• Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial
• If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic cancer
• Data presented at SITC 2022 showed a near tripling of overall response rate for pelareorep + gemcitabine + nab-paclitaxel + a PD-L1 inhibitor compared to historical control trials

 

San Diego, CA and Calgary, AB – June 22, 2023 – Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).

 

Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to pre-specified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials.

 

“We are delighted at being selected by the Precision Promise panel of experts,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. “Our next step is to engage with stakeholders to finalize the protocol for Precision Promise’s pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval.”

 

Julie Fleshman, JD, MBA, President and CEO of PanCAN commented, “With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care.”

 

Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech, commented, “Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one and two-year survival and objective response rate. In addition, mechanistic data from these studies highlight how pelareorep’s immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option.”

 

Oncolytics expects to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024.

 

Pelareorep in Pancreatic Cancer

 

Pelareorep’s inclusion in Precision Promise is supported by prior clinical data in pancreatic cancer that suggests it synergizes with checkpoint inhibition and chemotherapy. These prior data include phase 1/2 results showing a 69% objective response rate (ORR, n = 13) in a cohort of first-line advanced/metastatic PDAC patients treated with pelareorep combined with atezolizumab, gemcitabine, and nab-paclitaxel. This compares to an average ORR of ~25% reported in relevant historical control trials1-4. In addition, a phase 2 study of pelareorep plus gemcitabine that included 29 evaluable chemotherapy-naïve pancreatic cancer patients showed a median overall survival (mOS) of 10.2 months and a one-year survival rate of 45%, compared to historical control trials showing mOS of approximately 6.7 months and one-year survival rates of approximately 20 – 22%, respectively1,5-6. A subsequent phase 2 study of pelareorep plus checkpoint inhibition without chemotherapy in pancreatic cancer patients who progressed after first-line treatment showed a 42% disease control rate (n = 12), post-treatment increases in PD-L1+ cells, and a correlation between clinical response and increased activation of anti-cancer CD8+ T cells.

 

References
1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O’Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070
5. Conroy et al. N Engl J Med 2011; 364:1817-1825. DOI: 10.1056/NEJMoa1011923
6. Goldstein et al. JNCI J Natl Cancer Inst (2015) 107(2): DOI:10.1093/jnci/dju413

 

About the Pancreatic Cancer Action Network

 

The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive. For 18 years in a row, PanCAN has earned a Four-Star Rating from Charity Navigator – the highest rating an organization can receive. This rating designates PanCAN as an official “Give with Confidence” charity, indicating strong financial health, ongoing accountability and transparency.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; the design and anticipated benefits of the Precision Promise study, including our belief that the study, if successful, will support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma; our plan to engage with stakeholders to finalize the protocol for Precision Promise’s pelareorep-containing investigational treatment so that we can enter into the study; our expectation that we will be in a position to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024; our plans to advance towards a registrational study in metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
jpatton@oncolytics.ca Investor Relations for Oncolytics

 

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
tim@lifesciadvisors.com

 

Source:  Oncolytics

• Pelareorep-paclitaxel combination reduced risk of disease progression by 71% (hazard ratio of 0.29) compared to paclitaxel monotherapy
  

• 37.5% confirmed overall response rate with pelareorep-paclitaxel vs. 13.3% with paclitaxel monotherapy
  

• 12-month progression-free survival rate of 32.8% for pelareorep-paclitaxel compared to 0% for paclitaxel monotherapy and 0% for pelareorep-paclitaxel-avelumab
  

• Oncolytics’ HR+/HER2- breast cancer program now phase 3-ready and advancing to a registrational study of pelareorep-paclitaxel combination
  

• Data to be discussed during a key opinion leader webinar today, June 5^th at 8:00 a.m. ET (registration link here)
  

 

SAN DIEGO, CA and CALGARY, AB – June 5, 2023 – Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced updated results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer, which include data featured in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, as well as additional new data and analyses.

 

BRACELET-1 enrolled 48 patients, including 45 that were randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio^®). A three-patient safety run-in was also conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. All participants enrolled in the trial had previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor. No patients in BRACELET-1 received chemotherapy for metastatic disease prior to enrolling in the trial.

 

Updated data from BRACELET-1 showed a median progression-free survival (mPFS) of 9.5 months in the paclitaxel plus pelareorep cohort vs. 6.3 months in the paclitaxel monotherapy cohort for a hazard ratio of 0.29 as of a March 3, 2023 cut-off date. Confirmed overall response rate (ORR) in these cohorts was 37.5% and 13.3%, respectively. As previously reported, ORR at week-16 (the trial’s primary endpoint) in the pelareorep plus paclitaxel and paclitaxel monotherapy cohorts was 31.3% and 20%, respectively. Overall survival data from the trial continue to mature.

 

“BRACELET-1’s positive results complement prior phase 2 data showing a statistically significant increase in overall survival when pelareorep was combined with paclitaxel by demonstrating similar robust improvements in PFS and ORR in less heavily pre-treated patients,” said Dr. Matt Coffey, President and Chief Executive Officer. “Given this exciting finding, our next step is to discuss our data with the FDA to investigate incorporating dual PFS and OS endpoints into our breast cancer program’s registrational study. Including a PFS endpoint could substantially reduce the time to a pivotal readout from the registrational trial, thereby accelerating pelareorep’s path to potential approval as we work to address the urgent needs of HR+/HER2- breast cancer patients.”

 

A summary of response and PFS data from all 48 patients enrolled in BRACELET-1 is shown below.

 

Additional updated BRACELET-1 data ¹:

 

	Paclitaxel (PTX) Monotherapy (n=15)	PTX + Pelareorep (n=16)	PTX + Pelareorep + Avelumab (n=17)2
Confirmed ORR Over Course of Trial	2 (13.3%)	6 (37.5%)	3 (17.6%)
mPFS (months)	6.3 (95% CI: 3.9, NR)	9.5 (95% CI: 6.5, NR)	6.2 (95% CI: 4.0, NR)
PFS Hazard Ratio vs. PTX Monotherapy	–	0.29 (95% CI: 0.09, 0.98)	1.31 (95% CI: 0.47, 3.65)
12-month PFS Rate (%)	0 (95% CI: -, -)	32.8 (95% CI: 11.7, 92.4)	0 (95% CI: -, -)
1. Data from a March 3, 2023 cut-off date. Numbers presented may change as they are derived from an unlocked database. 2. Data include all patients enrolled in trial. Response data presented by Clark et al. at ASCO 2023 included the 45 randomized patients and excluded participants in the three-patient safety run-in in cohort 3. CI: Confidence interval; NR: Not reached.

 

Key biomarker and safety findings from BRACELET-1 include:

 

• Association between T cell expansion and efficacy measures: A statistically significant increase in T cell fraction, a measure of T cell expansion, was observed in cohort 2 (paclitaxel + pelareorep) but not cohort 3 (paclitaxel + pelareorep + avelumab)
• Generally favorable and manageable safety profile: Pelareorep displayed a manageable safety profile consistent with what has been observed in prior clinical trials that have collectively treated over 1,100 patients

 

Dr. Thomas Heineman, Chief Medical Officer, commented, “BRACELET-1’s impressive initial results are maturing quite favorably. While five patients in the pelareorep-paclitaxel group had partial responses at week 16, six patients in total had confirmed responses. This includes two patients who improved from stable disease to partial responses at later times, consistent with pelareorep’s immunologic mechanism of action. Moreover, the compelling ORR and PFS hazard ratio achieved align with translational results showcasing pelareorep’s immune-mediated mechanism of action and complement additional data that support the combination therapy’s generally favorable safety profile. Collectively, these results bolster an expansive clinical dataset supporting the potential of pelareorep-paclitaxel combination therapy in HR+/HER2- metastatic breast cancer and are expected to propel our program to a pivotal licensure-enabling study.”

 

A copy of slides from the ASCO oral presentation on BRACELET-1, titled “BRACELET-1 (PrE0113): Inducing an Inflammatory Phenotype in Metastatic HR+/HER2- Breast Cancer with the Oncolytic Reovirus Pelareorep in Combination with Paclitaxel and Avelumab,” is available on the Posters & Publications page of Oncolytics’ website (LINK). Additional data and analyses from BRACELET-1 beyond those reported at the ASCO Annual Meeting will be available in the most recent investor presentation available by clicking here. Details of the key opinion leader webinar are shown below.

 

Key Opinion Leader Webinar

 

Oncolytics will host a key opinion leader (KOL) webinar featuring Richard Vile, Ph.D., (Mayo Clinic), Aleix Prat, M.D., Ph.D. (Clínic Barcelona), and Martine J. Piccart, M.D., Ph.D. (Université Libre de Bruxelles) today, June 5, 2023 at 8:00 a.m. ET. During the webinar, the KOLs and members of the Oncolytics management will discuss the current treatment landscape for HR+/HER2- metastatic breast cancer, as well as BRACELET-1’s results. A live question and answer session will follow a formal presentation and roundtable discussion with the KOLs. To register for the event, please click here.

 

About BRACELET-1

 

The BRACELET-1 (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti-PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer. The study randomized 45 patients 1:1:1 into three cohorts. A three-patient safety run-in was also conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts are treated as follows:

 

• Cohort 1: paclitaxel

 

• Cohort 2: paclitaxel + pelareorep

 

• Cohort 3: paclitaxel + pelareorep + avelumab (Bavencio^®)

 

Patients in cohort 1 receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate at week 16. Exploratory endpoints include progression-free survival, peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; our plans to discuss our data with the FDA to enable our breast cancer program’s expeditious advancement to a registrational study with dual PFS and OS endpoints; the anticipated benefits of including a PFS endpoint in a registrational study; our expectation that the results of our BRACELET-1 study will propel our program to a pivotal licensing-enabling study; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

31% week-16 overall response rate and 9.6-month median progression-free survival with pelareorep plus paclitaxel vs. 20% and 6.4 months with paclitaxel alone as of Oct. 2022 ASCO abstract cut-off date

 

Updated data from May 2023 cut-off date will be presented in an oral presentation on June 3, 2023

 

Oncolytics to advance to registrational study of pelareorep-paclitaxel combination in HR+/HER2- breast cancer

 

SAN DIEGO, CA and CALGARY, AB – May 26, 2023 – Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced positive results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. The results are published in an abstract accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2 – 6, 2023 in Chicago, Illinois and online. The abstract is available on the ASCO Annual Meeting website.

 

BRACELET-1 enrolled 48 patients randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio^®). All participants enrolled in the trial previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor.

 

Compared to the paclitaxel monotherapy cohort, the cohort evaluating the combination of paclitaxel plus pelareorep showed ≥50% improvements on the trial’s primary endpoint of overall response rate (ORR) at week 16 (31.3% vs. 20%) as of the ASCO abstract cut-off date (October 2022). This cohort also reported median progression-free survival (mPFS) of 9.6 months vs. 6.4 months as of the cut-off date. Overall survival data from the trial continue to mature. Data from this study validate the results of IND-213, a prior phase 2 trial that showed a statistically significant near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep combined with paclitaxel (21.0 months, n = 28) vs. those treated with paclitaxel alone (10.8 months, n = 29).

 

“BRACELET-1 substantially de-risks our HR+/HER2- breast cancer program by providing a second randomized dataset showing pelareorep plus paclitaxel outperforming paclitaxel alone,” said Dr. Matt Coffey, President and Chief Executive Officer. “Importantly, evidence of pelareorep’s ability to synergistically enhance paclitaxel’s efficacy has now been seen consistently across multiple clinical efficacy endpoints of overall survival, progression-free survival, and ORR. With these data, our program is phase 3-ready, and efforts to expeditiously advance to a two-arm registrational study of pelareorep-paclitaxel combination therapy are well underway. I would like to thank BRACELET-1’s participants as well as our collaborators at Pfizer, Merck KGaA, Darmstadt, Germany, and PrECOG, all of whom contributed to an important trial that will inform and accelerate pelareorep’s path to approval.”

 

A detailed summary of BRACELET-1’s data are shown below. Updated results as of a May cut-off date will be featured in an oral presentation at the ASCO meeting on June 3, 2023.

 

Response and Progression-free Survival (October 2022 data cut-off):

 

	Paclitaxel (PTX) Monotherapy (n=15)	PTX + Pelareorep (n=16)	PTX + Pelareorep + Avelumab (n=17)
ORR at Week 161	3 (20%)	5 (31.3%)	3 (17.6%)
Disease Control Rate at Week 16 (CR+PR+SD)	7 (46.7%)	10 (62.5%)	12 (70.6%)
mPFS (months)1	6.4 (95% CI: 2.0, NR)	9.6 (95% CI: 6.5, NR)	7.5 (95% CI: 3.8, NR)
6-month PFS Rate	62.5% (95% CI: 27.6%, 84.2%)	92.9% (95% CI: 59.1%, 99%)	73.2% (95% CI: 42%, 89.4%)
1. Three patients who withdrew consent prior to starting therapy and two patints who discontinued treatment after week 1 were considered non-responders and censored for PFS CI: Confidence interval; CR: Complete response; PR: Partial response; SD: Stable disease; NR: Not reached

 

Biomarker and Safety

 

• A statistically significant increase in T cell fraction, a measure of T cell expansion, was observed in cohort 2 (paclitaxel + pelareorep) but not cohort 3 (paclitaxel + pelareorep + avelumab)
• Pelareorep displayed an acceptable safety profile consistent with what has been observed in prior clinical trials that have collectively treated over 1,100 patients

 

Dr. Thomas Heineman, Chief Medical Officer, commented, “BRACELET-1 was a well-conducted study in a randomized setting that included a control arm that performed as expected and a test arm that provides significant evidence of pelareorep’s ability to provide additional meaningful clinical benefit in HR+/HER2- breast cancer patients. Mechanistic data from prior clinical trials indicate pelareorep’s anti-cancer effects are derived from its ability to reverse immunosuppressive tumor microenvironments and stimulate the expansion of anti-cancer T cells. These prior data align with BRACELET-1’s results that show an association between T cell expansion and efficacy.”

 

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, “BRACELET-1’s data greatly enhance our pipeline’s value proposition, bringing our breast cancer program to pivotal trial-readiness and confirming pelareorep’s potential to address large markets by synergistically combining with other anti-cancer agents. Looking ahead, we believe our data in breast cancer, together with the second registration opportunity offered by our pancreatic cancer program, leave us well-positioned as we continue to execute our business development efforts. To ensure we maximize value for shareholders, we remain committed to taking a disciplined and methodical approach as we further discussions with our potential partners in the biopharma community.”

 

Details on the upcoming ASCO oral presentation on BRACELET-1 are shown below.

 

Title: BRACELET-1 (PrE0113): Inducing an Inflammatory Phenotype in Metastatic HR+/HER2- Breast Cancer with the Oncolytic Reovirus Pelareorep in Combination with Paclitaxel and Avelumab

Abstract Number: 1012

Session Type: Clinical Science Symposium

Session Title: The Dr. Bernard Fisher Memorial Annual Clinical Science Symposium Supported by the Breast Cancer Research Foundation: Harnessing the Breast Cancer Immune Response

Session Date and Time: June 3, 2023 | 1:15 p.m. – 2:45 p.m. CT

 

A copy of slides from the ASCO presentation will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the meeting.

 

About BRACELET-1

 

The BRACELET-1 (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti-PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Pfizer Inc. and Merck KGaA, Darmstadt, Germany. PrECOG LLC, a leading cancer research network, is managing the study. The study randomized 45 patients 1:1:1 into three cohorts. A three-patient safety run-in was also conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts are treated as follows:

• Cohort 1: paclitaxel
• Cohort 2: paclitaxel + pelareorep
• Cohort 3: paclitaxel + pelareorep + avelumab (Bavencio^®)

 

Patients in cohort 1 receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate at week 16. Exploratory endpoints include progression-free survival, peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; our belief that the BRACELET-1 study substantially de-risks our HR+/HER2- breast cancer program by providing a second dataset showing pelareorep plus paclitaxel outperforms paclitaxel alone; our belief that our program is phase 3-ready; pelareorep’s potential to address large markets by synergistically combining with other cancer agents; our belief that our data in breast cancer, together with the second registration opportunity offered by our pancreatic cancer program, leave us well-positioned as we continue to execute our business development efforts; our commitment to a disciplined and methodical approach as we further discussions with our potential partners in the biopharma industry; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.co

 

SOURCE:  Oncolytics Biotech^® Inc.

Randomized phase 2 data from BRACELET-1 trial in HR+/HER2- metastatic breast cancer to be shared in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting

 

Guidance on the registration paths for pelareorep in HR+/HER2- metastatic breast and first-line pancreatic cancer expected in H2 2023

 

$29.7 million in cash, cash equivalents, and marketable securities as of March 31, 2023 provides projected cash runway for at least 12 months

 

Management hosting conference call and webcast today at 8:30 a.m. ET

 

SAN DIEGO, CA and CALGARY – May 5, 2023 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the first quarter ended March 31, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted.

 

“Our core programs in breast and pancreatic cancer are moving towards registrational studies with compelling clinical data and important milestones expected this year,” said Dr. Matt Coffey, President and Chief Executive Officer. “The first of these milestones will come later this month when we report data from BRACELET-1, a randomized phase 2 trial expected to inform the design of a subsequent pivotal registrational study in HR+/HER2- metastatic breast cancer. Stakeholders across the breast cancer community have demonstrated a keen interest in this readout, which will add to a dataset that already includes statistically significant phase 2 results showing pelareorep’s ability to drive a robust overall survival benefit in this indication. Notably, the BRACELET-1 abstract was selected for an oral presentation at the upcoming ASCO meeting, providing a highly prestigious venue to discuss the results with potential partners and the clinical community.”

 

Dr. Coffey continued, “Looking into the second half of 2023, we expect to report updated results from GOBLET’s first-line pancreatic cancer cohort and provide guidance on the optimal registration paths for our breast and pancreatic cancer programs. With these programs both targeting large markets with significant clinical unmet needs and supported by robust clinical proof-of-concept data, we believe confirming their paths towards approval will represent important value-creating events and substantially de-risk and maintain pelareorep’s development pathway.”

 

First Quarter and Subsequent Highlights

 

Breast Cancer Program

 

BRACELET-1 data to be shared in an oral presentation at the ASCO Annual Meeting

 

BRACELET-1 is designed to confirm and expand upon Oncolytics’ prior positive clinical results for pelareorep in HR+/HER2- metastatic breast cancer and inform the design of a subsequent registrational study. These prior data include phase 1 results demonstrating pelareorep’s single-agent activity, as well as randomized phase 2 data that showed a statistically significant near doubling of median overall survival in patients treated with pelareorep combined with paclitaxel compared to those treated with paclitaxel monotherapy. Additionally, data from early-stage HR+/HER2- breast cancer patients demonstrated pelareorep’s ability to stimulate anti-tumor immunity, remodel tumor microenvironments, and potentially improve patient prognosis by decreasing the risk of cancer recurrence score.

 

BRACELET-1 includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep, and paclitaxel plus pelareorep in combination with avelumab in HR+/HER2- metastatic breast cancer. The trial was designed to enroll a total of 48 patients and is not powered to detect statistical significance. An abstract corresponding to the upcoming oral presentation will be published by ASCO on May 25, 2023, at 5:00 p.m. ET. The oral presentation will take place on June 3, 2023, during a session being held from 2:15 p.m. – 3:45 p.m. ET.

 

Additional Immunotherapeutic Opportunity

 

Upcoming ASCO poster on preclinical pelareorep-chimeric antigen receptor (CAR) T cell therapy combination program

 

The poster, titled “Efficacy of function-enhanced, re-activatable, dual-specific CAR T cells pre-loaded with oncolytic virus for immunotherapy of high-grade glioma,” will be presented in Poster Hall A from 2:15 p.m. – 5:15 p.m. ET on June 3, 2023. The corresponding abstract will be published prior to the ASCO meeting, on May 25, 2023, at 5:00 p.m. ET.

 

The data to be presented at the ASCO meeting follow preclinical results published in Science Translational Medicine (STM), which showed pelareorep synergistically enhancing the efficacy of CAR T cell therapy in murine solid tumor models (link to PR, link to the paper). Oncolytics is currently advancing preclinical research collaborations evaluating pelareorep-CAR T cell combination therapies, one of which has generated results with a potential partner’s own CAR T constructs that are in-line with those published in the STM publication.

 

Key Opinion Leader Webinar

 

Oncolytics will host a key opinion leader (KOL) webinar on June 5, 2023 at 8 a.m. ET, where KOLs and the Oncolytics management team will discuss recent data from the BRACELET-1 study. A live question and answer session will follow the formal presentation.

 

To register for the webinar, please click here.

 

Financial Highlights

 

• As of March 31, 2023, the Company reported $29.7 million in cash, cash equivalents, and marketable securities.

 

• The net loss for the first quarter of 2023 was $6.4 million, compared to a net loss of $6.8 million for the first quarter of 2022. The basic and diluted loss per share was $0.10 in the first quarter of 2023, compared to a basic and diluted loss per share of $0.12 in the first quarter of 2022.

 

• Net cash used in operating activities for the three months ended March 31, 2023 was $7.8 million, compared to $6.3 million for the three months ended March 31, 2022. The change reflected higher net operating activities and non-cash working capital changes.

 

• General and administrative expenses for the first quarter of 2023 were $3.2 million, compared to $2.6 million for the first quarter of 2022. The increase was mainly due to increased investor relations activities, partly offset by lower share-based compensation expense.

 

• Research and development expenses for the first quarter of 2023 were $3.5 million, compared to $3.7 million for the first quarter of 2022. The decrease was primarily due to lower BRACELET-1 study costs and share-based compensation expense, partly offset by increased manufacturing expenses associated with a process development production run and higher personnel-related expenses.

 

2023 Anticipated Milestones and Catalysts

 

• Overall response rate and progression-free survival data from phase 2 BRACELET-1 metastatic breast cancer study: Q2 2023
• Preclinical data from the combination of pelareorep and CAR T cell therapy: Q2 2023
• Updated data in advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) from the GOBLET study: H2 2023
• Update on the metastatic colorectal and anal cancer cohorts from the GOBLET study: H2 2023
• Guidance for the registration paths for HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC: H2 2023

 

Webcast and Conference Call

 

Management will host a conference call for analysts and investors at 8:30 a.m. ET today, May 5, 2023. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 3550-3191. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 503-191#.

 

ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)

(in thousands of Canadian dollars, except share amounts)

As at	March 31, 2023		December 31, 2022
Assets
Current assets
Cash and cash equivalents	$              15,872		$              11,666
Marketable securities	13,798		20,472
Other receivables	730		521
Prepaid expenses	3,861		3,025
Total current assets	34,261		35,684
Property and equipment	339		356
Right-of-use assets	501		296
Prepaid expenses	227		998
Total assets	$              35,328		$              37,334
Liabilities and Shareholders’ Equity
Current liabilities
Accounts payable and accrued liabilities	$                 2,232		$                 3,650
Lease liabilities	189		216
Warrant derivative	48		79
Total current liabilities	2,469		3,945
Contract liability	6,730		6,730
Lease liabilities	378		157
Total liabilities	9,577		10,832
Commitments and contingencies
Shareholders’ equity
Share capital Authorized: unlimited Issued: March 31, 2023 – 63,990,950 December 31, 2022 – 61,327,914	409,412		404,040
Contributed surplus	40,368		40,051
Accumulated other comprehensive income	659		662
Accumulated deficit	(424,688)		(418,251)
Total shareholders’ equity	25,751		26,502
Total liabilities and shareholders’ equity	$              35,328		$              37,334

 

ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands of Canadian dollars, except share amounts)

For the three months ended March 31,	2023		2022
Expenses
Research and development	$                      3,539		$                      3,708
General and administrative	3,195		2,602
Loss before the following	(6,734)		(6,310)
Change in fair value of warrant derivative	31		(13)
Foreign exchange gain (loss)	1		(474)
Interest income, net	265		18
Net loss	(6,437)		(6,779)
Other comprehensive loss items that may be reclassified to net loss
Translation adjustment	(3)		(47)
Net comprehensive loss	$                    (6,440)		$                    (6,826)
Basic and diluted loss per common share	$                       (0.10)		$                       (0.12)
Weighted average number of shares (basic and diluted)	62,344,544		56,576,462

 

ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(unaudited)

(in thousands of Canadian dollars)

	Share Capital		Warrants		Contributed Surplus		Accumulated Other Comprehensive Income		Accumulated Deficit		Total
As at December 31, 2021	$           391,348		$                3,618		$             34,161		$                     388		$         (393,416)		$             36,099
Net loss and other comprehensive loss	—		—		—		(47)		(6,779)		(6,826)
Issued pursuant to stock option plan (notes 6, 7)	19		—		(7)		—		—		12
Issued pursuant to incentive share award plan (notes 6, 7)	46		—		(46)		—		—		—
Issued pursuant to “At the Market” Agreement (note 6)	5,267		—		—		—		—		5,267
Share issue costs (note 6)	(176)		—		—		—		—		(176)
Share-based compensation expense (note 7)	—		—		639		—		—		639
As at March 31, 2022	$           396,504		$                3,618		$             34,747		$                     341		$         (400,195)		$             35,015
As at December 31, 2022	$           404,040		$                     —		$             40,051		$                     662		$         (418,251)		$             26,502
Net loss and other comprehensive loss	—		—		—		(3)		(6,437)		(6,440)
Issued pursuant to “At the Market” Agreement (note 6)	5,552		—		—		—		—		5,552
Share issue costs (note 6)	(180)		—		—		—		—		(180)
Share-based compensation expense (note 7)	—		—		317		—		—		317
As at March 31, 2023	$           409,412		$                     —		$             40,368		$                     659		$         (424,688)		$             25,751

 

ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands of Canadian dollars)

For the three months ended March 31,	2023		2022
Operating Activities
Net loss for the period	$                    (6,437)		$                    (6,779)
Depreciation – property and equipment	21		24
Depreciation – right-of-use-assets	76		74
Share-based compensation expense	317		639
Interest (income) expense, net	(96)		24
Unrealized foreign exchange (gain) loss	(124)		410
Change in fair value of warrant derivative	(31)		13
Change in non-cash working capital	(1,555)		(657)
Cash used in operating activities	(7,829)		(6,252)
Investing Activities
Acquisition of property and equipment	(5)		(36)
Maturities of marketable securities	6,674		—
Cash provided by (used in) investing activities	6,669		(36)
Financing Activities
Proceeds from exercise of stock options	—		12
Proceeds from “At the Market” equity distribution agreement	5,372		5,091
Payment of lease liabilities	(101)		(89)
Cash provided by financing activities	5,271		5,014
Increase (decrease) in cash and cash equivalents	4,111		(1,274)
Cash and cash equivalents, beginning of period	11,666		41,262
Impact of foreign exchange on cash and cash equivalents	95		(505)
Cash and cash equivalents, end of period	$                    15,872		$                    39,483

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; our 2023 milestones and catalysts and the anticipated timing thereof and expected benefits therefrom, including the release of data in relation to our BRACELET-1 study in Q2 2023, our study on the combination of pelareorep and CAR T cell therapy in Q2 2023; our GOBLET study in H2 2023 and the release of guidance for the registration paths for HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC in H2 2023; our plans to advance towards a registration study in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results or anticipated milestones and catalysts, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. Additionally, general market conditions resulting from high inflation, high interest rates, the Russia-Ukraine conflict, bank failures, general market uncertainty, and other macroeconomic factors, as well as market conditions affecting companies in the life sciences industry in general, may make it difficult to obtain financing from the capital markets on attractive terms or at all. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

  

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

Source:  Oncolytics Biotech^® Inc.

Thirteen of fourteen (93%) evaluable patients achieved disease control, with twelve (86%) showing tumor shrinkage

 

San Diego, CA and Calgary, AB – December 8, 2022 – Oncolytics Biotech^® Inc.’s (NASDAQ: ONCY) (TSX: ONC) Chinese partner Adlai Nortye today announced interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer. The data were featured in a poster presented yesterday at the San Antonio Breast Cancer Symposium (SABCS), which is being held at the Henry B. González Convention Center in San Antonio, Texas through December 10, 2022.

 

Fifteen patients were treated in the trial as of the data cut-off date (September 26, 2022), with fourteen having had at least one post-baseline tumor assessment (i.e., evaluable for efficacy). All patients enrolled into the trial were previously treated with at least one endocrine therapy and no more than one line of chemotherapy for recurrent/metastatic disease. Data and conclusions presented in the poster are summarized below.

 

• Disease control, partial response (PR) or stable disease (SD), was achieved in thirteen of fourteen evaluable patients (93%), with twelve (86%) showing tumor shrinkage from baseline.
• Seven of fourteen evaluable patients achieved a PR (50%). Three of these patients achieved a confirmed PR (20%), while two patients are awaiting potential confirmatory scans.
• One patient achieving a PR at week 8 has maintained the PR through week 48 and remains on study.
• Evolving median progression-free survival (PFS) for trial participants as of the data cut-off date was 9.1 months (95% confidence interval: 3.8 – NA).
• The studied combination has been well tolerated, with no dose-limiting toxicities or serious adverse events (SAEs) reported to date.

 

“These impressive results have us well-positioned to leverage Oncolytics’ prior positive data and join pelareorep’s global development program,” said Lars Birgerson, M.D., Ph.D., Adlai Nortye President and Chief Medical Officer. “With no SAEs reported, the data suggests the favorable safety and potent anti-cancer activity displayed by the studied combination in North American HR+/HER2- breast cancer patients extends to the Chinese population. There are also promising signs of pelareorep-paclitaxel combination therapy driving durable clinical benefit, with one patient notably still on study for nearly a year while maintaining a PR. We look forward to further characterizing the efficacy and durability of the studied combination as data from the trial mature and to continuing our collaboration with Oncolytics.”

 

Data from the bridging trial are expected to accelerate Adlai Nortye’s development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics’ North American metastatic breast cancer trials, IND-213 and BRACELET-1. IND-213 is a previously completed randomized phase 2 trial that showed a statistically significant near doubling of median overall survival when HR+/HER2- metastatic breast cancer patients were treated with paclitaxel plus pelareorep vs. paclitaxel alone. BRACELET-1 is an ongoing randomized phase 2 trial in HR+/HER2- metastatic breast cancer patients with cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 inhibitor avelumab. Oncolytics expects to report overall response rate, PFS, and evolving overall survival data from BRACELET-1 at a major medical meeting in the first half of 2023.

 

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, “BRACELET-1’s upcoming readout represents a crucial catalyst for Oncolytics, as data from the trial are expected to pave the way for pelareorep’s advancement to a registrational breast cancer study. We believe Adlai Nortye’s latest data significantly de-risk this upcoming readout as they validate IND-213’s positive results by confirming the ability of pelareorep plus paclitaxel to drive durable clinical responses in HR+/HER2- breast cancer patients. I’d like to thank Adlai Nortye for the productive partnership that led to these results, providing us with added enthusiasm for the outlook of our breast cancer program.”

 

A copy of the SABCS poster (P3-07-04), entitled, A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced/Metastatic Breast Cancer (REO 026-1), will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.

 

About Adlai Nortye

 

Adlai Nortye is a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, with its R&D centers in both China and the U.S. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with seven drug candidates in development, including (i) Buparlisib (AN2025), which was in a global Phase III clinical trial in combination with paclitaxel for the treatment of patients with recurrent or metastatic HNSCC after anti-PD-1/PD-L1 treatment; (ii) Palupiprant (AN0025), an oral EP4 antagonist which is undergoing Phase Ib trial in combination with Keytruda^® in patients with multiple solid tumors; and (iii) AN4005, an oral small molecule PD-L1 inhibitor which was currently in Phase Ia trial. Adlai Nortye is also conducting a Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025, AN0025 and atezolizumab (a PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in the U.S. In addition, Adlai Nortye owns the exclusive rights to Pelareorep (AN1004) in greater China, Singapore, and South Korea, and is conducting a bridging trial in China to assess the safety and tolerability of AN1004 in combination with paclitaxel for the Chinese patient population with metastatic HR+/HER2- breast cancer.

 

Adlai Nortye has assembled an experienced management team, built its proprietary immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The mission of the Company is to transform deadly cancer into a chronic and eventually a curable disease. For more information, please visit: www.adlainortye.com.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding the timing and anticipated content of upcoming poster presentations involving pelareorep; Oncolytics’ belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our expectation that data from the Adlai Nortye bridging trial will accelerate Adlai Nortye’s development of pelareorep in China; our expectation that data from the Adlai Nortye bridging trial will pave the way for pelareorep’s advancement to a registrational breast cancer study; our plans for clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid hematological malignancies; our plans to advance towards a registration study in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc

FDA Fast Track designation granted after presentation at the SITC 37^th Annual Meeting demonstrating 69% objective response rate

 

San Diego, CA and Calgary, AB – December 1, 2022 – Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep’s second FDA Fast Track designation.

 

“Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication,” stated Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. “We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study. With our core programs in breast and pancreatic cancer both nearing pivotal trials, and eligible for the Fast Track program’s numerous benefits, we believe we are at a crucial point in Oncolytics’ evolution and are excited for what’s ahead.”

 

In November 2022, at the Society for Immunotherapy of Cancer (SITC) 37^th Annual Meeting, Oncolytics reported interim clinical data showing a 69% objective response rate (ORR) including a complete response (n=13) in a cohort of first-line advanced/metastatic PDAC patients treated with the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in the Company’s phase 1/2 GOBLET study. This ORR is nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer^1-4.

 

Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need. For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation. A clinical program that receives Fast Track designation may benefit from more frequent meetings and communications with the FDA to discuss development plans and ensure the collection of appropriate data needed to support approval. In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.

 

References

1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O’Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding the timing and anticipated content of upcoming poster presentations involving pelareorep; Oncolytics’ belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our expectation regarding the effects and benefits of  Fast Track designation for pelareorep for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma; our plans to advance towards a registration study in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

• One complete response (CR) and eight partial responses (PR) achieved in thirteen evaluable patients 
• 69% objective response rate (ORR) is nearly three times greater than the average ORR of ~25% reported in historical control trials 
• Data support Oncolytics’ plan to advance its pancreatic cancer program into a pivotal study 
• Data to be discussed during a key opinion leader webinar on November 14^th at 10 a.m. ET 

 

SAN DIEGO, CA and CALGARY, AB – November 10, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced updated results from the phase 1/2 GOBLET study’s first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) cohort. Patients in this cohort are treated with the combination of pelareorep, Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel. The updated data are featured in a poster presentation at the ongoing Society for Immunotherapy of Cancer (SITC) 37^th Annual Meeting, which is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA.

 

Objective response rate (ORR) and clinical benefit rate (CBR) in GOBLET’s PDAC cohort (n=13) were 69% and 85%, respectively, as of the SITC poster’s data cutoff date (October 12, 2022). Additional data and conclusions presented in the poster are summarized below.

 

• One of thirteen evaluable patients achieved a confirmed CR
• Eight of thirteen evaluable patients achieved a PR
• Two of thirteen evaluable patients achieved stable disease (SD)
• The observed ORR of 69% is substantially higher than the average ORR of ~25% reported in historical control trials of gemcitabine and nab-paclitaxel in pancreatic cancer^1-4
• GOBLET’s PDAC cohort exceeded the protocol-specified success criterion for Stage 1 of ≥ 3/12 objective responses
• The studied treatment combination has been well tolerated, with no safety concerns identified to date

 

“GOBLET’s interim results indicate pelareorep may be the key to finally improving the standard-of-care for first-line treatment of pancreatic cancer, a clear need given that treatment options have not changed for many years despite their limited benefits,” commented Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. “The robust efficacy signal in GOBLET markedly exceeded expectations based on historical results and is especially encouraging as most responding patients had their tumor regressions confirmed by subsequent evaluations. We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy.”

 

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., added, “The impressive results being presented at SITC, together with prior clinical data providing a strong mechanistic rationale for the apparent synergies being displayed by pelareorep, PD-L1 inhibition, and chemotherapy, support our pancreatic cancer program’s advancement into a pivotal trial. We look forward to discussions with regulators to enable these efforts and align on the optimal design for a licensure-enabling study. In parallel, we continue to make strong progress with our breast cancer program; and are thrilled to be advancing a pipeline that includes two potentially compelling registration opportunities.”

 

The poster (#650), entitled, Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study, will be available for live viewing at the SITC meeting tomorrow, November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET. A copy of the poster will also be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the meeting.

 

Key Opinion Leader Webinar

 

Oncolytics will host a key opinion leader (KOL) webinar featuring Dirk Arnold, M.D., Ph.D. (Asklepios Tumorzentrum Hamburg), Andrea Bullock, M.D., MPH (Beth Israel Deaconess Medical Center) and Thomas Seufferlein, M.D., Ph.D. (Ulm University, Germany) on November 14, 2022 at 10 a.m. ET. During the webinar, the KOLs and members of the Oncolytics management team will discuss the current treatment landscape and unmet medical need in pancreatic cancer, as well as the updated interim GOBLET study results being presented at the SITC meeting. A live question and answer session will follow the formal presentations.

 

To register for the webinar, please click here.

 

References

 

1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O’Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070

 

About GOBLET

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

 

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line advanced/metastatic pancreatic cancer patients (n=12);

 

1. Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

 

1. Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients (n=14); and

 

1. Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients (n=10).

 

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

 

About AIO

 

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; our belief that pelareorep may be the key to finally improving the standard-of-care for first-line treatment of pancreatic cancer; the purpose and design of our ongoing clinical studies; our plans to advance towards a registration study in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

70% objective response rate (ORR; n=10) is nearly triple the average ORR of ~25% reported in historical control trials^1-4

  

Data suggest pelareorep synergizes with PD-(L)1 inhibitors and standard-of-care chemotherapy in advanced/metastatic pancreatic ductal adenocarcinoma

  

Oncolytics plans to present pancreatic cancer data to regulators to determine the most expeditious path to approval

  

Company management to discuss these results and ongoing efforts to advance pelareorep into registration studies in breast and pancreatic cancer during Q3 earnings call today at 8:30 a.m. ET

  

Updated data from GOBLET’s pancreatic cancer cohort to be presented in a poster at the SITC meeting and discussed during a key opinion leader webinar on November 14^th at 10 a.m. ET

  

San Diego, CA – November 7, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today reported interim results from the phase 1/2 GOBLET study’s first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) cohort in an abstract published as part of the Society for Immunotherapy of Cancer (SITC) 37^th Annual Meeting. The SITC meeting is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA, from November 8 – 12, 2022.

 

As of the abstract’s data cutoff date (July 28, 2022), seven of ten evaluable patients in GOBLET’s PDAC cohort, which evaluates pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel, achieved a partial response (3 confirmed, 4 unconfirmed as of the cutoff date). An additional two patients achieved stable disease for an ORR and clinical benefit rate of 70% and 90%, respectively. No safety signals were observed with the studied combination.

 

“The ORR reported in the SITC abstract is remarkably nearly triple the average ORR seen in historical control trials of gemcitabine plus nab-paclitaxel, which is only about 25%,” said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. “Further, PD-(L)1 inhibitors only benefit fewer than one percent of pancreatic cancer patients classified as MSI-high. GOBLET’s interim results, therefore, strongly suggest that pelareorep’s ability to reverse immunosuppressive tumor microenvironments produces synergies when combined with checkpoint inhibition and chemotherapy, leading to vastly improved responses. Given the urgent need for novel therapies in pancreatic cancer, I believe this exciting finding highlights an opportunity for pelareorep to transform the standard of care.”

 

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, “GOBLET’s interim results represent a crucial clinical milestone, providing robust proof-of-concept in a difficult-to-treat indication. Our next step is to discuss these data with regulatory authorities and potential partners, with the goal of advancing our pancreatic cancer program into a pivotal study. By adding a second near-term registration opportunity alongside our breast cancer program, we have enhanced pelareorep’s value proposition and further de-risked our clinical pipeline. I look forward to discussing the strategic implications of our new data during our earnings call today and to hearing expert perspectives on GOBLET’s results at our key opinion leader webinar next week.”

 

Updated results from GOBLET’s PDAC cohort, which is designed to enroll twelve evaluable patients, will be presented in a poster at the upcoming SITC meeting. The trial’s metastatic colorectal and advanced anal cancer cohorts are proceeding as planned, with the cohort in third-line metastatic colorectal cancer now fully enrolled.

 

Alongside this potential PDAC opportunity, Oncolytics continues to advance pelareorep towards a registration study in metastatic breast cancer. The company’s randomized phase 2 trial in HR+/HER2- metastatic breast cancer, BRACELET-1, remains on track for a readout on overall response rate, progression-free survival, and evolving overall survival data in the first half of 2023.

 

Additional details related to the SITC abstract and upcoming poster, entitled, Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study, are shown below.

 

Abstract Number: 650

Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET

Poster Session Location: Boston Convention and Exhibition Center, Hall C

 

A copy of the abstract is currently available for viewing in the Journal for ImmunoTherapy of Cancer (JITC) supplement. A copy of the poster will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the meeting.

 

Earnings Webcast and Conference Call

 

The Oncolytics management team will discuss the data published in the SITC abstract and the Company’s clinical development strategy in pancreatic cancer during its third quarter earnings call taking place today, November 7, 2022 at 8:30 a.m. ET. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 4240-6541. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 406-541#.

 

Key Opinion Leader Webinar

 

Oncolytics will host a key opinion leader (KOL) webinar on November 14, 2022 at 10 a.m. ET. During the webinar, the KOLs and members of the Oncolytics management team will discuss the current treatment landscape and unmet medical need in pancreatic cancer, as well as the updated interim GOBLET study results that will be presented at the SITC meeting. A live question and answer session will follow the formal presentations.

 

To register for the webinar, please click here.

 

References

1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O’Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070

 

About GOBLET

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

 

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line advanced/metastatic pancreatic cancer patients (n=12);

 

1. Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

 

1. Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients (n=14); and

 

1. Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients (n=10).

 

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

 

About AIO

 

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the mode of action, potential and benefits of pelareorep as a cancer therapeutic; our plan to discuss our GOBLET data with regulatory authorities and potential partners; our goal of advancing its pancreatic cancer program into a pivotal study; Oncolytics’ belief that pelareorep’s value proposition has been enhanced and that the Company’s clinical program has been further de-risked by virtue of the GOBLET data; the timing of release of updated GOBLET and BRACELET-1 results; our plans to advance towards a registration study in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Interim results from the phase 1/2 GOBLET study’s pancreatic cancer cohort to be presented in a poster on November 11^th and discussed during a key opinion leader webinar on November 14^th at 10 a.m. ET

 

SAN DIEGO, CA and CALGARY, AB –  October 5, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the acceptance of two abstracts for poster presentations at the Society for Immunotherapy of Cancer (SITC) 37^th Annual Meeting, which is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA, from November 8 – 12, 2022.

 

Both abstracts will be published by SITC at 8:00 a.m. ET on November 7, 2022. Additional details on the abstracts and corresponding poster presentations are shown below.

 

Title: Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study

Abstract Number: 650

Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET

Poster Session Location: Boston Convention and Exhibition Center, Hall C

 

Title: The oncolytic virus pelareorep in combination with immune checkpoint inhibitor activates T-cell functioning in early breast cancer patients – immunophenotype results from AWARE-1 study

Abstract Number: 548

Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET

Poster Session Location: Boston Convention and Exhibition Center, Hall C

 

Key Opinion Leader Webinar on Pancreatic Cancer and Interim Phase 1/2 GOBLET Study Data

Oncolytics will host a key opinion leader (KOL) webinar to discuss the current treatment landscape and unmet medical need in pancreatic cancer, as well as the interim GOBLET study results that will be presented at the SITC conference on November 14, 2022 at 10 a.m. ET. The webinar will include both formal presentations and a live question and answer session.

 

To register for the webinar, please click here.

 

About GOBLET

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

 

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line advanced/metastatic pancreatic cancer patients (n=12);

 

1. Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

 

1. Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients (n=14); and

 

1. Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients (n=10).

 

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE: Oncolytics Biotech^® Inc.

Partial responses achieved in all patients in cohort’s 1b portion

 

Expansion criteria for pancreatic cancer cohort has been met to allow for additional patient enrollment

 

Data suggest pelareorep synergistically combines with chemotherapy and checkpoint inhibition in a highly challenging indication and are featured in an abstract at the ESMO World Congress on Gastrointestinal Cancer

 

SAN DIEGO, CA and CALGARY, AB – June 28, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the pancreatic cancer cohort of the multi-indication phase 1/2 GOBLET study has met the efficacy expansion criteria for Stage 1 of the trial. The data from the phase 1b portion of this cohort, which are featured in an abstract accepted for a poster presentation at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2022, show a strong efficacy signal as evidenced by all patients achieving a partial response (n = 3). An independent safety review noted no toxicity concerns in these patients. The trial’s metastatic colorectal and advanced anal cancer cohorts are proceeding as planned.

 

The GOBLET study’s pancreatic cancer cohort is evaluating the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. Per the study’s Simon two-stage design, any cohort meeting a pre-specified efficacy threshold in Stage 1 (defined as achieving a minimum number of objective radiologic responses by week 16) may be expanded to enroll additional patients in an optional Stage 2 study expansion. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab combinations, the study seeks to assess the potential of CEACAM6 and T cell clonality to serve as predictive biomarkers that may increase the probability of success in subsequent trials by informing patient selection. The study is being conducted at 14 clinical sites in Germany and is being managed by AIO, a leading academic cooperative medical oncology group.

 

“With Stage 1’s pre-specified efficacy threshold met after just the first three patients, the GOBLET trial’s pancreatic cancer cohort is clearly exceeding expectations,” said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. “Novel therapeutic approaches are urgently needed in pancreatic cancer, as standard-of-care chemotherapy has a limited response rate, and less than 2% of patients are eligible for treatment with checkpoint inhibitors. Prior data in pancreatic cancer patients demonstrated pelareorep’s ability to remodel the tumor microenvironment to be less immunosuppressive. These latest results indicate that pelareorep’s immunotherapeutic effects may enhance the efficacy of checkpoint inhibitors in pancreatic cancer and increase tumor response rates. This promising finding suggests that pelareorep has the potential to dramatically improve the current therapeutic approach in an indication that is amongst the most difficult to treat.”

 

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, “Though early, these data provide a strong and exciting signal of efficacy for the studied combination. Looking forward, we will continue to follow this cohort closely to see if its initial positive results are substantiated as additional patients are evaluated and the data mature. If this impressive signal persists, it may enable us to pursue regulatory paths in pancreatic cancer that include subsequent trials designed to facilitate an expedited approval. We intend to engage regulators to gain insights on pelareorep’s optimal path forward in pancreatic cancer later this year and believe this program has the potential to provide a significant source of value that will complement our core efforts in breast cancer.”

 

Additional details related to the upcoming poster and corresponding abstract, entitled, GOBLET: A phase 1/2 multiple indication signal finding and biomarker study in advanced gastrointestinal cancers treated with pelareorep and atezolizumab – safety and preliminary response results, are shown below.

 

Congress Location: Centre de Convencions Internacional de Barcelona (Barcelona, Spain)

Session Date: Thursday, June 30, 2022

Session Times: 9:30 – 10:00 a.m. CET and 5:15 – 5:45 p.m. CET

Abstract Number: P-49

 

The poster’s corresponding abstract is currently available for viewing on the congress website (LINK). A copy of the poster will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the congress.

 

About GOBLET

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

 

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line advanced/metastatic pancreatic cancer patients (n=12);

 

Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

 

Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients (n=14); and

 

Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients (n=10).

 

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

 

About AIO

 

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

 

About Gastrointestinal Cancer

 

Excluding skin cancers, colorectal cancer is the third most common cancer, with estimates indicating that 106,180 new cases of colon cancer and 44,850 new cases of rectal cancer will be diagnosed in the U.S. in 2022¹. Also, for the 2022 year, the American Cancer Society estimates there will be 62,210 new cases of pancreatic cancer² and 9,440 new cases of anal cancer³ in the U.S.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References

 

1. “Key Statistics for Colorectal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html

 

1. “Key Statistics for Pancreatic Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html

 

1. “Key Statistics for Anal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/anal-cancer/about/what-is-key-statistics.html

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; Oncolytics’ expectations regarding its ability to  pursue regulatory paths in pancreatic cancer that include subsequent trials designed to facilitate an expedited approval; Oncolytics’ intention to engage regulators to gain insights on pelareorep’s optimal path forward in pancreatic cancer later this year; Oncolytics’ belief that its pancreatic cancer program has the potential to provide a significant source of value that will complement its core efforts in breast cancer; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Pelareorep treatment resulted in a favorable Risk of Recurrence Score (ROR-S) in 100% of evaluable patients compared to 55% at baseline in a window-of-opportunity study

  

Statistically significant increases in markers of tumor cell death and T cell activation observed following treatment with pelareorep-based combinations

 

SAN DIEGO, CA and CALGARY, AB – May 4, 2022 – Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research today announced new clinical biomarker data demonstrating pelareorep’s immunotherapeutic effects, synergy with checkpoint inhibition, and potential to improve the outlook for patients with HR+/HER2- breast cancer. The data, which are featured in a poster presentation at the 2022 European Society for Medical Oncology (ESMO) Breast Cancer Meeting, are from cohorts 1 and 2 of the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.

 

Patients in AWARE-1’s first two cohorts were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1), or with (cohort 2), the PD-L1 checkpoint inhibitor atezolizumab approximately 21 days prior to the surgical resection of their tumors. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with HR+/HER2- disease, the breast cancer subtype that Oncolytics intends to examine in a future registrational study. Previously reported results showed AWARE-1 met its primary translational endpoint, with cohort 2 achieving the pre-specified success criteria for treatment-induced increases in CelTIL score (link to the PR). CelTIL score is a metric for tumor inflammation and cellularity and is associated with improved clinical outcomes in breast cancer patients.

 

“The latest data from AWARE-1 further demonstrate pelareorep’s potential to improve clinical outcomes in breast cancer patients through its ability to activate T cells and remodel the tumor microenvironment,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. “Notably, pelareorep treatment increased markers of tumor cell death and, perhaps even more impressive, 100% of evaluable pelareorep-treated patients had a favorable Risk of Recurrence Score (ROR-S) compared to 55% at baseline. Together, these latest AWARE-1 results further establish pelareorep’s ability to attack tumors through multiple mechanisms.”

 

Key data and conclusions from the ESMO Breast Cancer poster include:

 

• Gene expression analyses showed 100% of evaluable patients had a Risk of Recurrence Score (ROR-S) classified as “low” at surgery vs. 55% with a “low” ROR-S at baseline (information pertaining to prognostic testing of gene signature assays in breast cancer can be found by clicking here)
• Treatment with pelareorep with (cohort 2) or without (cohort1) atezolizumab led to the conversion of tumors from the more aggressive luminal B to the luminal A subtype, which is associated with improved clinical outcomes
  • 100% of evaluable cohort 2 tumors were luminal A at surgery (21 days post-treatment) vs. 70% at baseline (pre-treatment)
  • 70% of evaluable cohort 1 patients had luminal A tumors at surgery vs. 40% at baseline
• Pooled analysis of tumors from cohorts 1 and 2 shows a statistically significant 4-fold post-treatment increase in the average expression of caspase 3, which is a marker of apoptotic cell death
• Pooled analysis across cohorts 1 and 2 shows statistically significant increases in markers of T cell activation and no significant changes in markers of T cell exhaustion from baseline to surgery

 

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, “AWARE-1’s results continue to exceed our expectations. With each new dataset, we gain additional clarity on how pelareorep’s immunologic mechanism of action synergistically combines with checkpoint inhibition. The study has also identified changes in blood T cell populations as a potential biomarker to predict patient response. We are now working to confirm these promising findings with efficacy data and additional biomarker analyses from our ongoing BRACELET-1 trial. If positive, we expect BRACELET-1’s results to inform the design of a registrational study in HR+/HER2- breast cancer and validate our broader strategy of developing pelareorep in combination with leading anti-cancer agents.”

 

BRACELET-1 is a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. The trial includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep, and paclitaxel plus pelareorep in combination with a checkpoint inhibitor. Top-line data from the trial are expected in Q4 2022.

 

The poster, entitled, The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients – Results from AWARE-1 study, is being presented during the “Biomarkers and translational research and precision medicine” session of the ESMO Breast Cancer Meeting. Following the conclusion of the meeting, the poster will be available on the Posters & Publications page of Oncolytics’ website (LINK).

 

About AWARE-1

AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; our plans to confirm our findings with efficacy data and additional biomarker analyses from our ongoing BRACELET-1 trial; our expectations that positive results from the BRACELET-1 trial may inform the design of a registrational study in HR+/HER2- breast cancer and validate our broader strategy of developing pelareorep in combination with leading anti-cancer agents; the anticipated timing of receipt of top-line data from the trial are expected in Q4 2022; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Pelareorep-CAR T combination may expand the commercial potential of CAR T cells to solid tumors

 

Combining CAR T cells with pelareorep prevented antigen escape by creating CAR T cells with dual specificity through a novel mechanism

 

Loading CAR T cells with pelareorep led to dramatic improvements in their persistence and anti-cancer activity as well as cures in multiple murine solid tumor models

  

SAN DIEGO, CA and CALGARY, AB – April 14, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the publication of preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with chimeric antigen receptor (CAR) T cell therapy in solid tumors. The paper, entitled “Oncolytic virus-mediated expansion of dual-specific CAR T cells improves efficacy against solid tumors in mice,” was published in Science Translational Medicine in collaboration with researchers at several prestigious institutions, including the Mayo Clinic and Duke University. A link to the paper can be found by clicking here.

 

“Having these results published in such a high-impact journal provides important external validation of their significance,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. “While CAR T cells have generated long-term cures in hematologic malignancies¹, the immunosuppressive tumor microenvironments (TMEs) of solid organ cancers have thus far limited their efficacy in these indications. Pelareorep has repeatedly been shown to reverse immunosuppressive TMEs, and in the present publication pelareorep is shown to enable the effectiveness of CAR T cells in multiple murine solid tumor models. This is a powerful finding that, if translated to the clinic, could significantly improve the prognosis of patients with a variety of highly prevalent cancers by providing a novel and potentially durable treatment option. By demonstrating the ability to improve T cell perseverance, reduce antigen escape, and overcome challenging solid tumor TMEs, the inclusion of pelareorep addresses the three most challenging roadblocks to effective CAR T therapy.”

 

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, “Despite revolutionizing the treatment of certain cancers and surpassing a billion dollars in sales last year, CAR T therapies currently only serve a small subset of patients suffering from hematologic malignancies. With these latest results, we now have strong preclinical evidence that pelareorep can fully unlock the value of CAR T therapies by expanding their commercial potential to the significantly larger market of cancer patients who are battling solid tumors.”

 

Preclinical studies published in the paper evaluated the persistence and efficacy of pelareorep-loaded CAR T cells (“CAR/Pela therapy”) in multiple murine solid tumor models. The effects of combining CAR/Pela therapy with a subsequent intravenous dose of pelareorep (“pelareorep boost”) were also investigated. Key data and conclusions from the paper include:

 

• The persistence and anti-cancer activity of CAR T cells improved drastically when loaded with pelareorep. Compared to either treatment alone, treatment with CAR/Pela therapy led to statistically significant survival benefits in murine skin and brain cancer models.
• CAR/Pela therapy followed by a pelareorep boost led to enhanced efficacy in murine skin and brain cancer models and tumor cures in >80% of treated mice in each model.
• Loading CAR T cells with pelareoep led to improved cancer cell targeting and prevented antigen escape in vivo by generating CAR T cells with dual specificity that target their designed antigen and the native T cell receptor antigen. These results indicate that CAR/Pela therapy may provide longer-lasting therapeutic benefits compared to treatment with CAR T cells alone.

 

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. and co-author of the paper commented, “These exciting results are an excellent example of how we are leveraging collaborations with key opinion leaders and premier research institutions to broaden pelareorep’s potential therapeutic impact. This allows us to remain primarily focused on our lead breast cancer program, which has shown how pelareorep’s ability to promote tumor T cell infiltration leads to synergy with checkpoint inhibitors in the clinic. These newly published preclinical findings show pelareorep’s synergistic benefits extend even beyond checkpoint inhibitors and highlight an opportunity to increase our addressable patient population. As we pursue this opportunity moving forward, we intend to utilize relationships with academic or industry partners so that we can continue to execute on our clinical and corporate objectives with efficiency.”

 

About CAR T cells and CAR T therapy

 

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.²

 

About Science Translational Medicine

 

Science Translational Medicine is the leading weekly online journal publishing translational research at the intersection of science, engineering, and medicine. The goal of Science Translational Medicine is to promote human health by providing a forum for communicating the latest research advances from biomedical, translational, and clinical researchers from all established and emerging disciplines relevant to medicine. In addition to original research, Science Translational Medicine also publishes Reviews, Editorials, Focus articles, and Viewpoints.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References

 

1. Melenhorst, J.J., Chen, G.M., Wang, M. et al.Decade-long leukaemia remissions with persistence of CD4⁺ CAR T cells. Nature (2022). https://doi.org/10.1038/s41586-021-04390-6
2. National Cancer Institute. CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. Updated July 31, 2019. Accessed February 18, 2021. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; including potentially significantly improving the prognosis of patients with a variety of highly-prevalent cancers by providing them with a novel and potentially durable treatment option and the opportunity to potentially expand our addressable patient population; our intention to utilize relationships with academic or industry partners so that we can continue to execute on our clinical and corporate objectives with efficiency; our leveraging of collaborations with key opinion leaders to broaden pelareorep’s potential therapeutic impact; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE: Oncolytics Biotech^® Inc.

First two cohorts indicate pelareorep in combination with paclitaxel was well-tolerated with no new safety signals observed to date

 

Trial is designed to satisfy regulatory requirements and accelerate pelareorep’s development in large and rapidly growing pharmaceutical markets, including China, Hong Kong, Macau, Taiwan, Singapore, and South Korea

 

Final cohort’s dosing regimen is equivalent to Oncolytics’ North American phase 2 trial in metastatic breast cancer (BRACELET-1)

 

SAN DIEGO, CA and CALGARY, AB, March 24, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that its partner Adlai Nortye has advanced to the third and final dose escalation cohort of the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. The trial’s first two cohorts have completed their dose escalation evaluation periods and indicated pelareorep in combination with paclitaxel was well-tolerated with no new safety signals observed to date.

 

The dosing regimens for the bridging trial’s second and third cohorts are equivalent to those administered in Oncolytics’ randomized North American breast cancer trials, IND-213 and BRACELET-1, respectively. In IND-213, HR+/HER2- breast cancer patients treated with pelareorep and paclitaxel showed a statistically significant, near doubling of overall survival compared to those treated with paclitaxel alone. BRACELET-1, an ongoing phase 2 study evaluating pelareorep-paclitaxel combination therapy with and without a checkpoint inhibitor, is on track for a top-line data readout in Q4 2022 that will inform the design of a registrational study in the United States. Final results from the Chinese bridging trial are expected to accelerate pelareorep’s development in territories such as China, Hong Kong, and Macau, by allowing Adlai Nortye to include data from IND-213 and BRACELET-1 in future submissions to regulators in these jurisdictions.

 

“The territories covered by our partnership with Adlai Nortye represent an important component of our business development strategy, as China and the other areas in which Adlai Nortye anticipates commercializing pelareorep are among the largest in the world and growing rapidly,” said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. “With the bridging trial entering its final cohort less than six months after dosing began, Adlai is making major strides towards satisfying the regulatory criteria needed to accelerate pelareorep’s development in China. The trial also continues to generate positive safety data, which will serve us well as we collaborate with Adlai Nortye to advance pelareorep towards approval in key global markets.”

 

About Breast Cancer

 

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 2020¹. In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 2020².

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Adlai Nortye

 

Adlai Nortye is a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, with its R&D centers in both China and the U.S. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with more than 10 drug candidates in development. Currently, four of them are being investigated in multiple clinical trials, including (i) Buparlisib(AN2025) which received the FDA Fast-Track designation and was in a global Phase III clinical trial; (ii) Pelareorep (AN1004), an intravenously delivered oncolytic virus which received the FDA Fast-Track designation and have completed a phase II clinical trial; (iii) Palupiprant (AN0025), an oral EP4 antagonist which has completed Phase Ib trial in a neoadjuvant setting in localized advanced rectal cancer and is undergoing Phase Ib trial in combination with Keytruda® in patients with multiple solid tumors; and (iv) AN4005, an orally available, small molecule PD-L1 inhibitor which was currently in Phase Ia trial that was shown to functionally overcome the inhibition derived from PD-1/L1 interaction in reporter- and human PBMC (hPBMC)-based cellular assays. In addition, Adlai Nortye also completed the first patient dosing for its Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025, AN0025 and Tecentriq® (PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in September 2021 in the U.S.

 

Adlai Nortye has assembled an experienced management team, built its proprietary immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The mission of the Company is to transform deadly cancer into a chronic and eventually a curable disease. For more information, please visit: www.adlainortye.com.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References

1. “Breast Cancer Statistics and Resources.” Breast Cancer Research Foundation. https://www.bcrf.org/breast-cancer-statistics-and-resources
2.  Cao, Wei, et al; Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020, Chinese Medical Journal: April 5, 2021 – Volume 134 – Issue 7 – p 783-791. doi:10.1097/CM9.0000000000001474;

https://journals.lww.com/cmj/Fulltext/2021/04050/Changing_profiles_of_cancer_burden_worldwide_and.5.aspx

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; including management’s belief that the BRACELET-1 study is on track for a top-line data readout in Q4 2022 that will inform the design of a registrational study in the United States; management’s expectation that final results from the Chinese bridging trial are expected to accelerate pelareorep’s development in territories such as China, Hong Kong, and Macau, by allowing Adlai as China and the areas in which Adlai Nortye anticipates commercializing pelareorep to include data from IND-213 and BRACELET-1 in future submissions to regulators in these jurisdictions; management’s beliefs as to the rapid growth in the areas in which Adlai Nortye anticipates commercializing pelareorep; management’s belief that the Company is making major strides towards satisfying the regulatory criteria needed to accelerate pelareorep’s development in China and the other areas in which Adlai anticipates commercializing pelareorep; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Independent safety review completed with no toxicity concerns

 

Cohort builds on prior proof-of-concept data demonstrating clinical benefit of pelareorep-checkpoint inhibitor combination in pancreatic cancer

 

Multi-indication trial being conducted in collaboration with Roche and AIO also includes cohorts in metastatic colorectal and advanced anal cancers

 

SAN DIEGO, CA and CALGARY, AB – February 2, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the successful completion of the three-patient safety run-in for the pancreatic cancer cohort of the phase 1/2 GOBLET study following evaluation by the study’s Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns in these patients and recommended the study proceed as planned. The safety run-in for the trial’s third-line metastatic colorectal cancer cohort remains ongoing.

 

The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.

 

“This positive safety evaluation adds to a robust body of evidence demonstrating the favorable safety profile of pelareorep-checkpoint inhibitor combinations across multiple indications,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. “It also represents an important step in the development of these combinations for the treatment of pancreatic cancer and builds on prior clinical proof-of-concept data in this indication. These data highlight the potential of pelareorep to benefit patients with pancreatic and other gastrointestinal cancers by reversing immunosuppressive tumor microenvironments that limit the effectiveness of checkpoint inhibitors. We believe adding pelareorep to treatment regimens will improve clinical response rates in these patients, and we look forward to evaluating this hypothesis through successfully advancing the GOBLET study.”

 

The GOBLET study’s pancreatic cancer cohort extends previously reported clinical data demonstrating the synergy and anti-cancer activity of pelareorep combined with checkpoint inhibition in pancreatic cancer patients who progressed after first-line treatment (link to PR, link to poster). It also builds on prior early clinical data that showed a greater than 80% increase in median progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression who received pelareorep in combination with chemotherapy (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, GOBLET also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may increase the likelihood of success of future registrational studies by allowing selection of the most appropriate patients.

 

About GOBLET

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

 

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line metastatic pancreatic cancer patients (n=12);
2. Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
3. Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients (n=14); and
4. Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients (n=10).

 

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

 

About AIO

 

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

 

About Gastrointestinal Cancer

 

Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer expected to be diagnosed in the U.S. in 2021¹. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer² and 9,090 new cases of anal cancer³ in the U.S.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References

1. “Key Statistics for Colorectal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
2. “Key Statistics for Pancreatic Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
3. “Key Statistics for Anal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/anal-cancer/about/what-is-key-statistics.html

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; management’s expectations as to enrollment in the Company’s GOBLET study; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Enrollment in the first dose escalation is complete with no safety issues reported to date

 

Trial is designed to accelerate pelareorep’s development in Asian territories such as China, the world’s second-largest pharmaceutical market

 

SAN DIEGO, CA and CALGARY, AB – January 27, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that its partner Adlai Nortye has advanced to the second of three dose escalation cohorts in the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Dosing in the trial’s first dose escalation cohort is complete and no safety issues have been reported. The second dose escalation cohort is the equivalent dose that was administered in the IND-213 study, which reported a near doubling of survival in HR+/HER2- metastatic breast cancer patients.

 

“Initiation of the bridging trial’s second dose escalation cohort is an important advancement that reflects the positive safety findings observed in the trial to date,” said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. “Completion of the bridging trial will allow future Chinese regulatory submissions that will include previously reported clinical data demonstrating pelareorep’s potential to substantially benefit metastatic breast cancer patients. This may accelerate pelareorep’s development in rapidly growing pharmaceutical markets such as China, which is the second largest in the world after the United States. Looking ahead, we will continue to collaborate closely with Adlai Nortye to advance pelareorep towards registration in these jurisdictions and maximize its potential therapeutic impact.”

 

The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep’s development in territories that include China, Hong Kong, and Macau. Results from the trial are expected to allow Adlai Nortye to include data from Oncolytics’ randomized North American metastatic breast cancer trials in future submissions to regulators in China and its territories.

 

The first of Oncolytics’ randomized North American trials, IND-213, showed a statistically significant near doubling of overall survival in patients treated with pelareorep and paclitaxel compared to those treated with paclitaxel alone. Oncolytics’ second randomized North American trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor. Oncolytics expects to complete enrollment in BRACELET-1 later this quarter and to report top-line data from the trial in Q4. Oncolytics believes completion of BRACELET-1 represents the last major clinical step on pelareorep’s path to a registrational study in metastatic breast cancer in the United States.

 

About Breast Cancer

 

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 2020¹. In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 2020².

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Adlai Nortye

 

Adlai Nortye is a global clinical-stage biopharmaceutical company focused on innovative oncology drugs, with its R&D and global clinical operation centers in both China and the United States. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with more than 10 drug candidates in development. Currently, four of them are being investigated in multiple clinical trials, including the FDA Fast-Track designated Buparlisib (AN2025) in a global phase III clinical trial; the FDA Fast-Track designated intravenously administered oncolytic virus pelareorep (AN1004) to have completed a phase II clinical trial; an oral EP4 antagonist (AN0025, Palupiprant) has completed Phase 1b trial in a neoadjuvant setting in locally advanced rectal cancer and is undergoing Phase 1b trial in combination with Keytruda^® in patients with multiple solid tumors; an oral small molecule PD-L1 drug (AN4005) currently in Phase 1 trial that was shown to functionally overcome the inhibition derived from PD-1/L1 interaction in reporter- and human PBMC (hPBMC)-based cellular assays. In addition, the Company also completed the first patient dosing for its Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025, AN0025 and atezolizumab (PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in September 2021 in the U.S.

 

The Company has assembled a world-class management team, built its unique immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The ultimate goal of the Company is to transform cancer into manageable conditions. For more information, please visit: www.adlainortye.com.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References

1. “Breast Cancer Statistics and Resources.” Breast Cancer Research Foundation. https://www.bcrf.org/breast-cancer-statistics-and-resources
2.  Cao, Wei, et al; Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020, Chinese Medical Journal: April 5, 2021 – Volume 134 – Issue 7 – p 783-791. doi:10.1097/CM9.0000000000001474;

https://journals.lww.com/cmj/Fulltext/2021/04050/Changing_profiles_of_cancer_burden_worldwide_and.5.aspx

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; pelareorep’s potential to substantially benefit metastatic breast cancer patients; the potential acceleration of pelareorep’s development in rapidly growing pharmaceutical markets such as China; Oncolytics’ plans to continue to collaborate closely with Adlai Nortye to advance pelareorep towards registration in certain jurisdictions and maximize its potential therapeutic impact; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Successfully enrolled first-line metastatic pancreatic and third-line metastatic colorectal safety run-ins 

 

Company moving to full enrollment pending independent safety review 

 

Multi-center trial being conducted in collaboration with Roche and AIO builds on prior promising data from pancreatic and colorectal cancer trials

 

SAN DIEGO, CA and CALGARY, AB –  January 20, 2022 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) provided an enrollment update on the phase 1/2 GOBLET study in a poster presentation at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI).

 

The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes three-patient safety run-ins for two of its four cohorts (first-line metastatic pancreatic and third-line metastatic colorectal cancer). Enrollment in these safety run-ins is complete. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.

 

“There is a pressing unmet need for agents that can synergize with immune checkpoint inhibitors (ICI) in gastrointestinal (GI) cancers, as fewer than half of these patients respond to ICI monotherapy,” said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. “These low response rates are driven by immunosuppressive tumor microenvironments, which pelareorep has been shown to reverse in prior clinical studies in GI, breast, and hematological cancers. We thus believe pelareorep can increase the proportion of GI cancer patients responding to checkpoint inhibitors and are seeking to validate this hypothesis in the GOBLET study. We are very pleased with the trial’s progress to date and look forward to its continued advancement.”

 

The GOBLET study builds on previously reported clinical proof-of-concept data for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the study also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may allow selection of the most appropriate patients in future registration studies and increase their likelihood of success.

 

A copy of the ASCO-GI poster titled, “GOBLET: A phase 1 / 2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal cancers exploring treatment combinations with pelareorep and atezolizumab,” will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.

 

About GOBLET

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line metastatic pancreatic cancer patients (n=12);
2. Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
3. Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients (n=14); and
4. Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients (n=10).

 

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

 

About AIO

 

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

 

About Gastrointestinal Cancer

 

Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer expected to be diagnosed in the U.S. in 2021¹. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer² and 9,090 new cases of anal cancer³ in the U.S.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References

1. “Key Statistics for Colorectal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
2. “Key Statistics for Pancreatic Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
3. “Key Statistics for Anal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/anal-cancer/about/what-is-key-statistics.html

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; management’s expectations as to enrollment in the Company’s GOBLET study; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech Inc.

Dr. Heineman has over two decades of experience successfully leading clinical development programs and previously served as Oncolytics’ Global Head of Clinical Development and Operations

 

SAN DIEGO, CA and CALGARY, AB, December 21, 2021 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Thomas (Tom) C. Heineman, M.D., Ph.D., has been promoted to the role of Chief Medical Officer (CMO). Dr. Heineman has over two decades of experience leading clinical development programs and previously served as Oncolytics’ Global Head of Clinical Development and Operations.

 

“Tom’s clinical expertise, deep understanding of oncology drug development, and impressive track record make him an ideal fit as our CMO,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. “Since joining Oncolytics in August 2020, Tom has provided crucial insights that have enabled the efficient advancement of our lead breast cancer program and facilitated our pipeline’s expansion into additional indications. Looking forward, Tom’s strategic guidance will continue to be an invaluable asset as we move towards a registration study in metastatic breast cancer and advance our broader pipeline.”

 

Dr. Heineman added, “The opportunity to serve as Oncolytics’ CMO is exciting. Pelareorep’s ability to recruit anti-cancer immune cells into tumors and promote an inflamed microenvironment positions it as a potential immunotherapeutic backbone that can enable the success of a wide range of immuno-oncology agents. We have demonstrated clinical proof-of-concept in several high unmet need indications and are now building on these results in ongoing trials. As CMO, I look forward to leading the clinical development of pelareorep through these and future trials, and to my continued work alongside my highly talented colleagues at Oncolytics.”

 

Prior to joining Oncolytics, Dr. Heineman was Senior Vice President and Head of Clinical Development at Denovo Biopharma. Prior to his time at Denovo, he served as Vice President and Head of Clinical Development at both Genocea Biosciences and Halozyme Therapeutics. At Halozyme, Dr. Heineman was also Head of Translational Medicine and oversaw clinical trials in indications such as breast and pancreatic cancer. Dr. Heineman’s experience further extends to big pharma and academia, as he previously worked as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine.

 

Dr. Heineman has co-authored over 60 peer-reviewed publications and is board certified in Internal Medicine and Infectious Diseases. He completed his fellowship in Infectious Diseases at the National Institutes of Health and his internship and residency at the University of Maryland. Dr. Heineman earned his M.D. and Ph.D. in Virology at the University of Chicago.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Treatment with intravenous pelareorep plus azacitidine reduced tumor burden

 

Treatment with pelareorep and azacitidine dramatically upregulated multiple genes known to drive anti-cancer immune responses

 

SAN DIEGO, CA and CALGARY, AB – December 15, 2021 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) announced preclinical data demonstrating the synergistic anti-leukemic effects of pelareorep combined with the chemotherapeutic agent azacitidine. The data were featured in a poster presentation at the 2021 American Society of Hematology (ASH) Annual Meeting, which took place from December 11-14, 2021, in Atlanta, Georgia.

 

• Preclinical studies featured in the poster evaluated pelareorep in combination with azacitidine in acute myeloid leukemia (AML) cells in vitro and in a leukemia xenograft mouse model. Key data and conclusions from the poster include:

 

• Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant reduction (p<0.01) in tumor burden in a leukemia xenograft mouse model

 

• Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant (p<0.001) synergistic enhancement of anti-leukemic activity against AML cell lines, a benefit that was confirmed in AML patient samples in vitro

 

• The combination of pelareorep and azacitidine dramatically upregulated multiple genes known to drive anti-cancer immune responses such as IFNβ1, BATF2, IL-12β, CCL2, TLR3, and PD-L1

 

“These compelling preclinical findings, together with previously reported data demonstrating clinical proof-of-concept in multiple myeloma, indicate that pelareorep’s immunotherapeutic effects extend across multiple hematological malignancies. They also further highlight pelareorep’s potential to enhance the efficacy of a wide range of cancer therapeutics and have stimulated interest in investigator-sponsored clinical studies of pelareorep in leukemia,” said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. “Given its ability to be administered intravenously without special handling procedures, pelareorep exerts a systemic effect that is uniquely suited to address liquid tumors compared to other oncolytic viruses. We look forward to leveraging collaborative relationships to continue evaluating pelareorep in hematological malignancies, which will allow us to potentially broaden its therapeutic impact while maintaining our primary focus on our lead breast cancer program.”

 

A copy of the ASH poster titled, “The Clinical Oncolytic Reovirus Formulation Reolysin Synergistically Augments the Anti-Leukemic Activity of Azacitidine,” is available on the Posters & Publications page of Oncolytics’ website (LINK).

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; the potential to leverage collaborative relationships to continue evaluating pelareorep and potentially broaden its therapeutic impact; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc

No safety concerns have been noted in any trial participants

 

Trial builds on prior clinical data demonstrating pelareorep’s ability to reverse immunosuppressive tumor microenvironments and upregulate PD-L1 expression in breast cancer

 

SAN DIEGO, CA and CALGARY, AB – December 10, 2021 – Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) announced a positive interim safety update from the investigator-sponsored, phase 2 IRENE trial in a poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS).

 

The IRENE trial is designed to evaluate the safety and efficacy of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC). Safety data from the trial show that the combination has been well-tolerated, as no safety concerns have been noted in any of the five patients enrolled in the trial at the time of reporting. The trial remains ongoing and will continue to enroll patients at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.

 

Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey, Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, and principal investigator of the trial commented, “Checkpoint inhibitors benefit only a minority of TNBC patients due to immunosuppressive tumor microenvironments (TMEs) and poor PD-L1 expression. Prior clinical studies have shown that pelareorep upregulates tumor PD-L1 expression and reverses immunosuppressive TMEs. These findings suggest that pelareorep can address a pressing unmet need in TNBC by synergizing with PD-1 inhibition to increase the proportion of patients responding to therapy. We look forward to evaluating this hypothesis through the IRENE study’s continued advancement and are pleased that the pelareorep-retifanlimab combination has been well-tolerated in each of the patients enrolled in the trial.”

 

In addition to evaluating the safety and efficacy of pelareorep plus retifanlimab, IRENE is also designed to assess changes in PD-L1 expression and correlations between treatment outcomes and changes in peripheral blood T cell populations. This could provide a potential biomarker of pelareorep response that may enable the success of future registrational trials by allowing for the early identification of patients most likely to respond to therapy.

 

A copy of the SABCS poster titled, “IRENE study: Phase 2 study of Retifanlimab and the oncolytic virus pelareorep in metastatic triple negative breast cancer,” will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.

 

About IRENE

 

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) for the second- or third-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and is being conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

 

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. Retifanlimab will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression-free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

 

For more information on the IRENE study, refer to https://clinicaltrials.gov/ct2/show/NCT04445844.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Multi-center trial is being conducted in collaboration with Roche and AIO

 

Trial is designed to assess the safety and efficacy of pelareorep-atezolizumab combination therapies across multiple gastrointestinal cancer indications

 

Trial builds on prior promising data from pancreatic and colorectal cancer trials

 

San Diego, CA and Calgary, AB – November 3, 2021 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the first patient has been dosed in the phase 1/2 GOBLET trial. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to investigate the use of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers.

 

“Fewer than half of gastrointestinal (GI) cancer patients respond to immune checkpoint inhibitor (ICI) monotherapy, creating a pressing unmet need for techniques to enhance the efficacy of these agents,” said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. “We believe that pelareorep can address this need and increase the proportion of GI cancer patients responding to ICIs, as clinical studies have shown that it reverses the immunosuppressive tumor microenvironments underlying checkpoint inhibitor resistance. Dosing the first patient in GOBLET represents a crucial step towards the evaluation of this hypothesis, and we look forward to the trial’s continued advancement.”

 

The GOBLET study builds on data that was recently presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting that demonstrated clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may allow selection of the most appropriate patients in future registration studies and increase their likelihood of success.

 

About GOBLET

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 15 centers in Germany. The primary endpoint of the study is safety, with overall response rate and biomarker evaluation (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned to be enrolled in four independent cohorts:

 

• Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^stline metastatic pancreatic cancer patients (n=12);
• Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
• Pelareorep in combination with atezolizumab and TAS-102 in 3^rdline metastatic colorectal cancer patients (n=14); and
• Pelareorep in combination with atezolizumab in 2^ndline advanced and unresectable anal cancer patients (n=10).

 

About AIO

 

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

 

About Gastrointestinal Cancer

 

Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer expected to be diagnosed in the U.S. in 2021¹. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer² and 9,090 new cases of anal cancer³ in the U.S.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References:

“Key Statistics for Colorectal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html

“Key Statistics for Pancreatic Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html

“Key Statistics for Anal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/anal-cancer/about/what-is-key-statistics.html

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech Inc.

 

Trial is designed to advance pelareorep’s clinical development in China, the world’s second-largest pharmaceutical market

 

San Diego, CA and Calgary, AB – October 14, 2021 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that its partner Adlai Nortye has initiated dosing in a bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer.

 

Results from the bridging trial are expected to allow Adlai Nortye to include data from Oncolytics’ North American metastatic breast cancer trials in a future submission to Chinese regulators. The first of Oncolytics’ randomized phase 2 trials, IND-213, showed that treatment with pelareorep and paclitaxel led to a statistically significant increase in overall survival compared to treatment with paclitaxel alone. Oncolytics’ second randomized phase 2 trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor.

 

“Adlai’s bridging trial is an important step forward for pelareorep’s clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second-largest in the world,” said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. “We are very pleased that dosing in the trial has commenced and congratulate our partner on this notable achievement. Looking ahead, we are eager to continue our partnership with Adlai as we work to advance pelareorep towards registration in major global markets.”

 

About Breast Cancer

 

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 2020.¹ In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 2020.²

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Adlai Nortye

 

Adlai Nortye is a global clinical-stage biopharmaceutical company focused on innovative oncology drugs, with its R&D and global clinical operation centers in both China and the United States. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with more than 10 drug candidates in development. Currently, three of them are being investigated in clinical trials, including the FDA Fast-Track designated Buparlisib (AN2025) in a global phase III clinical trial; the FDA Fast-Track designated intravenously administered oncolytic virus Pelareorep (AN1004) to have completed a phase II clinical trial; and an oral EP4 antagonist (AN0025) is in early-stage clinical development in multiple tumor types in combination with other treatment options including chemo-radiation and anti‑PD‑1/anti‑PD‑L1 therapies.

 

The Company has assembled a world-class management team, built its unique immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The ultimate goal of the Company is to transform cancer into manageable conditions. For more information, please visit: www.adlainortye.com.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References:

 

“Breast Cancer Statistics and Resources.” Breast Cancer Research Foundation. https://www.bcrf.org/breast-cancer-statistics-and-resources

Cao, Wei, et al; Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020, Chinese Medical Journal: April 5, 2021 – Volume 134 – Issue 7 – p 783-791. doi:10.1097/CM9.0000000000001474; https://journals.lww.com/cmj/Fulltext/2021/04050/Changing_profiles_of_cancer_burden_worldwide_and.5.aspx

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the mode of action and potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; the anticipated timing of completion of enrollment in Oncolytics’ BRACELET-1 study; our goals, objectives and strategies; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Combination treatment with pelareorep and radiotherapy promoted the tumor infiltration of anti-cancer T cells and prolonged survival in a murine cancer model

 

Increased infiltration of anti-cancer T cells was observed both in tumors exposed to local treatment with radiation and pelareorep and in tumors located away from the treatment site

 

San Diego, CA and Calgary, AB, September 20, 2021 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced preclinical data demonstrating the synergistic immunotherapeutic effects of pelareorep combined with radiotherapy in a murine cancer model. The data were featured in a poster presentation at The International Conference on Immunotherapy Radiation Combinations, which took place in Paris, France from September 14 – 17, 2021.

 

Preclinical studies presented in the poster evaluated various treatment combinations of pelareorep, ionizing radiation (radiotherapy), and anti-PD-1 therapy in mice with two bilateral tumors, each located subcutaneously (under the skin) on a different side of the body. Radiotherapy and/or pelareorep treatment was delivered locally to one tumor (denoted the primary tumor), while the second tumor (denoted the abscopal tumor) was not directly exposed to either therapy. Anti-PD-1 therapy was delivered systemically.

 

Results showed that in primary tumors, pelareorep monotherapy led to a numerical increase in the number of infiltrating anti-cancer CD8+ T cells, which reached statistical significance when combined with radiotherapy (a 15-fold increase compared to control). In abscopal tumors, both pelareorep monotherapy and pelareorep-radiation combination therapy led to a statistically significant increase in infiltrating anti-cancer CD8+ T cells. This effect was not seen with single-agent radiotherapy in either the primary or the abscopal tumors.

 

Local delivery of radiotherapy alone and the pelareorep-radiotherapy combination into primary tumors significantly improved survival compared to untreated controls. Compared to single-agent radiotherapy, the pelareorep-radiotherapy combination led to a numerical increase in survival, which reached statistical significance when anti-PD-1 therapy was added to the treatment regimen.

 

“The observed increases in survival and in the number of anti-cancer immune cells within both primary and abscopal tumors following treatment is indicative of the synergistic immunotherapeutic effects of the pelareorep-radiotherapy combination,” said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. “This is a compelling finding that has the potential to be broadly applicable across multiple cancer indications and warrants further study. Together with prior clinical and preclinical data, these results also highlight pelareorep’s potential as an enabling technology to enhance the efficacy of a wide range of therapies.”

 

A copy of the poster titled, “Combination treatment with radiotherapy and oncolytic reovirus generates CD8+ T cell infiltration in primary and abscopal tumours in an organoid model of basal-like breast cancer,” can be found on the Posters & Publications page of Oncolytics’ website (LINK).

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the mode of action and potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; our goals, objectives and strategies; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca

 

Investor Relations for Oncolytics

Timothy McCarthy

LifeSci Advisors

+1-917-679-9282

tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech Inc.

 

The study achieved a 42% disease control rate in difficult-to-treat, second-line pancreatic cancer patients despite the absence of chemotherapy in the treatment regimen

  

Pelareorep and pembrolizumab synergize to generate anti-cancer immune responses in patients showing disease control

  

Clinical response was associated with increased activation of anti-cancer CD8+ T cells

 

SAN DIEGO, CA and CALGARY, AB – May 20, 2021 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer. The data will be featured in an upcoming electronic poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place virtually from June 4 – 8, 2021.

 

The newly announced data are from a phase 2 trial evaluating pelareorep in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA^®) in pancreatic adenocarcinoma patients who progressed after first-line treatment. Findings from the trial indicate that pelareorep and pembrolizumab synergize and show anti-cancer activity in these difficult-to-treat patients, which is mediated through the complementary immunotherapeutic effects of the two agents.

 

“These results are very promising, particularly considering the extremely challenging patient population enrolled in the trial. That we saw a response signal in select patients, despite the absence of chemotherapy, provides evidence of the considerable anti-cancer activity of pelareorep-pembrolizumab combination therapy,” said Principal Investigator, Devalingam Mahalingam, M.D., Ph.D., Associate Professor of Medicine at The Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “We notably observed an association between treatment-induced anti-cancer immune responses and improved tumor control in some patients, which demonstrates pelareorep’s underlying immunologic mechanism of action and validates the strategy of combining it with checkpoint inhibition. I look forward to discussing these data with the scientific community at the upcoming ASCO conference and to the continued evaluation of pelareorep-checkpoint inhibitor combination therapy in select patients with pancreatic and other gastrointestinal cancers.”

 

The data presented in the upcoming ASCO poster represent an update based on additional data that was collected after the cutoff date used for the poster’s corresponding abstract. Key data and conclusions that will be featured in this upcoming poster include:

 

• Disease control was achieved in 42% (5/12) of patients, with one patient achieving a partial response and four patients achieving stable disease

 

• On-treatment tumor biopsies showed pelareorep replication and increased infiltration of CD8+ T cells and PD-L1+ cells relative to pre-treatment samples

 

• Patients achieving disease control showed reductions in pro-tumor regulatory T (T­_reg) cells in the peripheral blood and tumor tissue compared to those with progressive disease

 

• Patients achieving disease control showed increased activation of anti-cancer CD8+ T cells in the peripheral blood compared to those with progressive disease

 

• Pelareorep-pembrolizumab combination therapy was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2

 

Bin Zhang, M.D., Ph.D., Professor at The Northwestern University Feinberg School of Medicine, commented, “These data show that pelareorep can train the immune system to target pancreatic cancer while simultaneously promoting the infiltration of T cells into the tumor and remodeling the tumor microenvironments (TMEs) to be less immunosuppressive. This positions pelareorep to synergistically combine with both checkpoint inhibitors as well as a broad range of other immuno-oncology agents.”

 

“The findings from this study highlight the broad applicability of pelareorep’s immunotherapeutic mechanism of action as they are consistent with what has been seen in clinical trials in other indications such as breast cancer,” added Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. “The compelling findings from this phase 2 study highlight the potential of pelareorep to address the critical unmet need in pancreatic cancer by reversing the immunosuppressive TMEs that often limit the efficacy of checkpoint inhibitors. The anti-cancer activity demonstrated in this study bodes well for a successful outcome in our GOBLET trial, which includes a cohort evaluating pelareorep and the PD-L1 inhibitor atezolizumab in combination with chemotherapy as first-line therapy in metastatic pancreatic cancer patients.”

 

The electronic poster, titled, “Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma” will be made available on the ASCO Annual Meeting website at 9:00 a.m. ET on June 4, 2021. A copy of the poster will also be posted on the Posters & Publications page of Oncolytics’ website (LINK).

 

Oncolytics plans to further develop pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer in collaboration with Roche and AIO-Studien-gGmbH (AIO) through the GOBLET study, a phase 1/2 multi-center trial designed to investigate the use of pelareorep in combination with Roche’s anti-PD-L1 inhibitor atezolizumab (Tecentriq^®) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers (link to the GOBLET announcement PR). Oncolytics expects the first patient to be dosed in GOBLET in mid-2021.

 

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and biomarker evaluation (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts:

 

• Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^stline metastatic pancreatic cancer patients (n=12);
• Pelareorep in combination with atezolizumab in 2^nd and 3^rdline metastatic colorectal cancer patients that are diagnosed as MSI (microsatellite instability) high (n=19);
• Pelareorep in combination with atezolizumab and TAS-102 in 3^rdline metastatic colorectal cancer patients (n=14); and
• Pelareorep in combination with atezolizumab in 2^ndline advanced and unresectable anal cancer patients (n=10).

 

About Gastrointestinal Cancer

Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,610 new cases of colon cancer and 43,340 new cases of rectal cancer diagnosed in the U.S. in 2020¹. Also, for the 2020 year, the American Cancer Society estimates there will be 57,600 new cases of pancreatic cancer² and 8,590 new cases of anal cancer ³ in the U.S.

 

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

References:

 

• “Key Statistics for Colorectal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
• “Key Statistics for Pancreatic Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
• “Key Statistics for Anal Cancer.” The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/anal-cancer/about/what-is-key-statistics.html

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics’ expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; the timing and anticipated content of the presentation of additional data to be given at the 2021 ASCO annual meeting; our plans to further develop pelareorep through collaborations; the anticipated timing of the first patient being dosed under our GOBLET-1 study; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca   Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech^® Inc.

Mayo Clinic shows pelareorep vastly improved persistence and efficacy of CAR T cell therapy leading to cures in this model

  

Pelareorep’s synergistic effects with CAR T therapy appear to be specific and were not observed with the oncolytic virus VSV

  

Results demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors

  

San Diego, CA and Calgary, AB – February 23, 2021 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) announced publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors.

 

Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Efficacy of pelareorep-loaded CAR T cell (“CAR/Pela”) therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep (“pelareorep boost”), generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Survival data from the preclinical study are shown below:

 

Therapy	Survival Rate at End of Study
PBS (vehicle)	0% (0/7)
CAR T	14% (1/7)
Pelareorep	0% (0/7)
Pelareorep + Pelareorep boost	0% (0/7)
CAR/Pela	57% (4/7)
CAR/Pela + pelareorep boost	100% (7/7)
CAR/Pela + VSV boost	42% (3/7)

 

“These very exciting data demonstrate pelareorep’s ability to overcome major shortcomings of CAR T cells,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. “Despite commercial success in hematological cancers, CAR T therapies have limited efficacy against solid tumors due to immunosuppressive tumor microenvironments (TMEs) that promote T cell exhaustion and exclusion. Pelareorep’s ability to reverse immunosuppressive TMEs has been well documented in the clinic, and combining CAR T cells with pelareorep may enable their success against solid cancers. This would be a major advancement, as it would substantially broaden the applicability of CAR T cells to a variety of highly prevalent and difficult-to-treat indications.”

 

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, “While our primary focus is on advancing our lead breast cancer program to a registrational trial, we continue to evaluate additional opportunities to expand pelareorep’s business development and partnership potential. In clinical studies, pelareorep recruited high concentrations of T cells to solid tumors, positioning it to synergistically interact with checkpoint inhibitors. In this newly published study, we show the synergistic benefits of pelareorep can be extended to additional cutting-edge immunotherapeutic agents. Based on these findings, we are specifically exploring a partnership strategy to further the development of pelareorep as an enabling technology for CAR T cells and additional immunotherapies that require immune effector cell infiltration in solid tumors.”

 

The electronic poster titled “Combination Therapy with Oncolytic Viruses and CAR T Cells,” was developed in collaboration with researchers from the Mayo Clinic, Duke University, and Oncolytics. It is available on the Posters & Publications page of Oncolytics’ website (LINK).

 

About CAR T cells and CAR T therapy

 

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply, and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.¹

 

About Pelareorep

 

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

References:

1. National Cancer Institute. CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. Updated July 31, 2019. Accessed February 18, 2021. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, potential commercial opportunities for pelareorep; the Company’s primary focus on advancing its lead breast cancer program to a registrational trial; the Company’s evaluation and pursuit of business development and partnership potential opportunities; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Kirk Look Chief Financial Officer +1-403-670-7658 KLook@oncolytics.ca
Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

SOURCE:  Oncolytics Biotech Inc.

Pelareorep strongly increases CelTIL score, the primary endpoint and a measure of tumor cellularity and inflammation associated with favorable clinical outcomes

 

 Pelareorep increased tumor PD-L1 expression 105-fold, thereby making the tumors more amenable to immuno-checkpoint inhibitor treatment

 

 San Diego, CA and Calgary, AB  – December 9, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Breast Cancer Research today published an electronic poster at the 2020 San Antonio Breast Cancer Symposium (SABCS) with data from the AWARE-1 window-of-opportunity study in patients with early-stage breast cancer showing pelareorep delivers a significant boost known to increase the effectiveness of checkpoint inhibitors.

 

In the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, early-stage breast cancer patients are treated with pelareorep, with or without atezolizumab (Tecentriq^®), plus an appropriate therapy for each patient’s breast cancer subtype, followed by surgery. The SABCS poster includes 17 out of the 20 HR+/HER2- breast cancer patients comprising the study’s first two cohorts, the targeted patient population for our intended phase 3 study. Treatment with pelareorep increased the CelTIL score in tumor biopsies, which has been associated with improved clinical outcomes. In addition, pelareorep treatment dramatically upregulated PD-L1 expression in the tumor microenvironment (TME). These findings highlight the potential of pelareorep to act synergistically with checkpoint inhibitors and also provides a basis for the near doubling of overall survival observed in a prior phase 2 trial when pelareorep was added to chemotherapy in HR+/HER2- breast cancer patients (link to PR, link to poster).

 

“AWARE-1 data demonstrate pelareorep’s consistent remodeling of the tumor immune environment,” said Dr. Aleix Prat, M.D., Ph.D., Translational Investigator of AWARE-1, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. “Pelareorep seems to train the immune system to target cancer cells while simultaneously promoting tumor inflammation and priming a response to immune checkpoint blockade. This demonstrates pelareorep’s potential to overcome the immunosuppressive nature of the tumor microenvironment which could limit checkpoint inhibitor efficacy.”

 

Key data and conclusions from the SABCS poster include:

 

• 72% of evaluated patients (n=18) saw an increase in CelTIL, the study’s primary endpoint that is associated with favorable clinical outcomes.

 

• The maximum percentage increase in CelTIL (~300%) was achieved in a cohort 2 patient receiving pelareorep in combination with checkpoint blockade therapy.

 

• On average, there was a 105-fold increase in TME PD-L1 expression (n=13) from baseline (pre-pelareorep administration) to surgery (21-days post-administration).

 

• Tumor microenvironment PD-L1 expression increased in all evaluated patients (n=13).

 

• Preliminary imaging mass cytometry analysis showed pelareorep treatment promoted broad anti-tumor changes in the TME, including enhanced CD8+ T cell activation and the recruitment of memory T cells.

 

Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, “In the AWARE-1 study, pelareorep delivered consistent increases in tumor PD-L1 expression and recruitment of anti-cancer immune cells into tumors, as well as increases in CelTIL score for over 70% of the patients. This is highly encouraging given the association between CelTIL and clinical outcomes, and we hope to observe the same success from our phase 2 BRACELET-1 trial, which is  exclusively enrolling HR+/HER2- breast cancer patients.”

 

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, “Immune deserts or immunosuppressive tumor microenvironments limit tumor PD-L1 expression levels and thereby limit regulatory approval and commercial success of checkpoint inhibitors in certain breast and other malignancies. AWARE-1 data show that pelareorep can alter the tumor microenvironment and induce robust PD-L1 expression, highlighting the potential of pelareorep to boost the efficacy of checkpoint inhibitors and increase the proportion of patients eligible for these therapies. We expect this synergistic potential to enable the continued execution of our strategy to develop pelareorep-based therapies in collaboration with industry leaders.”

 

The electronic poster, titled “A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)” is available in the SABCS virtual poster hall and on the Posters & Publications page of Oncolytics’ website (LINK).

 

Ongoing ‘trial-in-progress’ posters giving an overview of Oncolytics’ IRENE and BRACELET-1 study designs were also presented at SABCS and are available at the same locations.

 

About AWARE-1

 

AWARE-1 is an open-label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

 

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

 

• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

 

• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

 

• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

 

• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

 

The study combines pelareorep, with or without atezolizumab, and the standard of care therapy according to breast cancer subtype. Patients are biopsied as part of their initial breast cancer evaluation, then again on day three following initial treatment, and a final tissue sample after three weeks, on the day of their mastectomy. Data generated from this study are intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

 

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

 

Tecentriq^® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

 

About Breast Cancer

 

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Pelareorep

 

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About SOLTI

 

SOLTI is a leading cooperative group in the field of clinical cancer research. With its academic and translational core, the group is committed to designing and executing clinical trials based on the molecular biology of tumors. Its focus is on breast cancer, but it also explores other kinds of tumors. The main goal of SOLTI is to promote through disruptive means the development of innovative research that will improve the well-being and future outcomes of cancer patients. Since its creation in 1995, SOLTI’s purpose has been to bring about a paradigm shift in clinical and translational cancer research from within academia. With 77 clinical trials under their belt and more than 30 ongoing investigations, SOLTI counts on the work of more than 400 researchers from a network comprising more than 100 hospitals in Spain and Portugal, all coordinated by the team of 50 workers from the head office. SOLTI is a member of the Spanish Society of Medical Oncology (SEOM).

 

To find out more about SOLTI, visit www.gruposolti.org / Twitter: @SOLTI / LinkedIn / Youtube

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the Company’s intentions regarding a potential phase 3 study involving pelareorep; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company Contact Kirk Look Chief Financial Officer +1-403-670-7658 KLook@oncolytics.ca
Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

 

Source:  Oncolytics Biotech^® Inc.

AWARE-1 data support the results of a prior phase 2 trial that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- breast cancer patients

  

Data show pelareorep-induced generation and expansion of anti-tumor T cell clones that may contribute to a durable anti-cancer immune memory effect and improve outcomes in breast cancer

  

70% of cohort-1 patients saw an increase in CelTIL, the study’s primary endpoint and a measure of tumor inflammation that is associated with favorable clinical outcomes

  

San Diego, CA and Calgary, AB – November 9, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Breast Cancer Research today announced the publication of an electronic poster with clinical data from the AWARE-1 window-of-opportunity breast cancer study at The Society for Immunotherapy of Cancer (SITC) 35^th Anniversary Annual Meeting.

 

The AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, combines the appropriate intervention for each patient’s breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq^®), followed by surgery in early-stage breast cancer patients. Data presented in the electronic poster were from the ten HR+/HER2- breast cancer patients that make up the study’s first cohort. These data demonstrate the ability of pelareorep to promote a pro-inflammatory tumor microenvironment (TME) and provide a basis for the findings of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- breast cancer patients (link to PR, link to poster).

 

“AWARE-1’s elegant paired-biopsy design allows us to assess the impact of pelareorep on each patient’s tumor immune environment, and the results to date have been very promising,” said Dr. Aleix Prat, M.D., PhD., Translational Investigator of the Study, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. “These data continue to support pelareorep’s ability to train the immune system to target cancer and highlight its potential to address a critical unmet need by increasing the number of patients responding to checkpoint inhibitor therapies. Data presented at SITC showing pelareorep-induced generation and expansion of anti-tumor and anti-viral T cell clones are also noteworthy, as they suggest the induction of a durable anti-cancer immune memory effect. These data, together with previously reported AWARE-1 results, provide strong support for the observed survival benefit in a prior randomized phase 2 study evaluating pelareorep in metastatic breast cancer patients.”

 

Key data and conclusions from the electronic poster include:

 

• Tumor-cell specific pelareorep replication was observed in all cohort-1 patients following systemic pelareorep administration

 

• 70% of cohort 1 patients saw an increase in CelTIL, the study’s primary endpoint and a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes

 

• On average, there was a 14-fold increase in intratumoral CD8+ T cells from baseline (pre-pelareorep administration) to surgery (21-days post-administration), with increases observed in all cohort-1 patients

 

• Pelareorep administration led to the generation and expansion of new T cell clones in the tumor and periphery, which included both anti-tumor and anti-viral clones

 

Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, “These newly announced AWARE-1 results add to the promising clinical dataset supporting pelareorep’s immunotherapeutic mechanism of action and to the proposed registration pathway in our lead metastatic breast cancer program. The observed 70% CelTIL response rate in cohort-1 patients is highly encouraging, as CelTIL is associated with favorable patient outcomes, and this response rate was achieved despite the absence of checkpoint blockade therapy. Further, previously announced data have shown that CelTIL scores correlate with high peripheral T cell clonality, underscoring T cell clonality’s potential as a predictive biomarker that may facilitate the design of future registrational trials and improve their chances of success. We look forward to presenting additional AWARE-1 data later this year and to the continued progress of the trial, which will be key as we move our lead breast cancer program towards a registrational study.”

 

The electronic poster, titled, “Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer” is being presented at SITC by Dr. Prat. As of the SITC data cut-off, AWARE-1 has enrolled 23 out of 38 patients, including all patients in the study’s first two cohorts.

 

Details on the AWARE-1 electronic poster, which are available on the SITC 2020 website and on the Posters & Publications page of Oncolytics’ website (LINK), are shown below.

 

Poster Number: 806

Title: Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer

Presentation Date and Time: Thursday, November 12 from 4:50-5:20 p.m. EST and Saturday, November 14 from 1:00-1:30 p.m. EST

Presenter: Dr. Aleix Prat

 

About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

 

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

 

• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

 

• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

 

• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

 

• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

 

The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

 

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

  

About Breast Cancer

 

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Pelareorep

 

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About SOLTI

 

SOLTI is a leading cooperative group in the field of clinical cancer research. With its academic and translational core, the group is committed to designing and executing clinical trials based on the molecular biology of tumors. Its focus is on breast cancer, but it also explores other kinds of tumors. The main goal of SOLTI is to promote through disruptive means the development of innovative research that will improve the well-being and future outcomes of cancer patients. Since its creation in 1995, SOLTI’s purpose has been to bring about a paradigm shift in clinical and translational cancer research from within academia. With 77 clinical trials under their belt and more than 30 ongoing investigations, SOLTI counts on the work of more than 400 researchers from a network comprising more than 100 hospitals in Spain and Portugal, all coordinated by the team of 50 workers from the head office. SOLTI is a member of the Spanish Society of Medical Oncology (SEOM).

To find out more about SOLTI, visit www.gruposolti.org / Twitter: @SOLTI / LinkedIn / Youtube

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action and benefits of pelareorep as a cancer therapeutic; the Company’s expectations respecting the delivery of additional clinical data and the timing thereof; the Company’s expectations respecting potential future registrational trials and the likelihood of success thereof; the timing of the presentation of the clinical data from the Company’s AWARE-1 study at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company Contact Kirk Look Chief Financial Officer +1-403-670-7658 KLook@oncolytics.ca     Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

Source:  Oncolytics Biotech Inc.

Multi-center trial to assess the safety and efficacy of pelareorep-atezolizumab combination therapies across multiple GI cancer indications

 

Treatment aimed at 4.8M global GI cancer cases annually¹ and the approximately 80% of GI cancer patients who do not respond to immune checkpoint inhibitor therapy currently

 

Study builds on prior early findings of greater than 90% clinical benefit in colorectal and greater than 80% increase in progression-free survival in pancreatic cancer patients

 

San Diego, CA and Calgary, AB – October 27, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced a new multi-indication gastrointestinal (GI) cancer study to be managed by AIO, a leading academic cooperative medical oncology group based in Germany.  The phase 1/2 trial, known as GOBLET, will investigate the use of pelareorep, in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq^®), in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers.

 

“We are very excited for the opportunity to treat patients with pelareorep, which has the potential to address significant unmet needs across multiple challenging indications with poor prognoses in the GI cancer space,” said Dirk Arnold M.D., Ph.D., Director of the Asklepios Tumorzentrum Hamburg, and principal investigator of the newly announced trial. “Despite the great commercial success of checkpoint inhibitors, as many as four in five patients do not respond to these therapies in most GI malignancies, often due to an immunosuppressive tumor microenvironment (TME). We believe that pelareorep treatment may substantially increase the proportion of patients who are eligible for, and respond to, checkpoint inhibitor therapy. Prior clinical data in breast, hematological, and also some early data in gastrointestinal cancers have shown that systemic pelareorep administration reverses immunosuppressive TMEs by increasing tumor immune cell infiltration and PD-L1 expression.”

 

Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, added, “In this trial, we aim to demonstrate that the great potential shown by pelareorep in our lead breast cancer program can be extended to other advanced malignancies for which new treatments are needed. Pelareorep’s potential in GI cancers is supported by the encouraging early clinical data we previously reported in pancreatic and colorectal cancer, which showed that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study), and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). We hope the GOBLET study, in addition to providing positive safety and efficacy data, will also support our previously identified predictive blood-based biomarkers CEACAM6 and T cell clonality. This will allow us to select the most appropriate patients for future registration studies, thereby increasing their likelihood of success.”

 

The GOBLET study will make use of a new master clinical supply agreement between Oncolytics and Roche. Per the agreement, Roche will supply atezolizumab for use in Oncolytics’ clinical development plan.

 

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, said, “The GOBLET study represents an exciting opportunity to further expand the commercial opportunity of pelareorep beyond our primary focus of breast cancer. We are especially grateful for Roche’s support of this study, which we view as an encouraging sign for pelareorep, the study design, and our strategy to develop pelareorep-based therapies in collaboration with industry leaders.  We are hopeful that the continued execution of this strategy could result in the rapid development and approval of pelareorep-based therapies for use in metastatic breast cancer and other indications.”

 

About GOBLET

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and blood-based biomarkers (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts:

 

>> Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line metastatic Pancreatic cancer patients (n=12);

 

>> Pelareorep in combination with atezolizumab in 2^nd and 3^rd line metastatic colorectal cancer patients that are diagnosed as MSI high (microsatellite instability) (n=19);

 

>> Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients (n=14); and

 

>> Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients (n=10).

 

About Tecentriq^®

 

Tecentriq^® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About Pelareorep

 

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About AIO

 

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society. AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

References:

 

Arnold M, Abnet CC, Neale RE, Vignat J, Giovannucci El, McGlynn KA, Bray F. Global Burden of 5 Major Types of Gastrointestinal Cancer. Gastroenterology. 2020 Apr 2:S0016-5085(20)30452-2. doi: 10.1053/j.gastro.2020.02.068. https://pubmed.ncbi.nlm.nih.gov/32247694/. PMID: 32247694.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic; the design, aims and timing of our GOBLET gastrointestinal cancer study; the potential for the GOBLET study to expand the commercial opportunity of pelareorep beyond the Company’s primary focus of breast cancer; the potential for our planned strategic approach to result in the rapid development and approval of pelareorep-based therapies for use in metastatic breast cancer and other indications; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Kirk Look Chief Financial Officer 403.670.7658 KLook@oncolytics.ca   Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 917.679.9282 tim@lifesciadvisors.com   Source:  Oncolytics Biotech® Inc.

Expansion of Oncolytics’ lead breast cancer program into a new disease subtype

 

Seek synergies between pelareorep and retifanlimab checkpoint inhibitor

 

San Diego, CA and Calgary, AB – August 26, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the first patient has been dosed in the Company’s investigator-sponsored phase 2 study of pelareorep-anti-PD-1 combination therapy in unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The study, known as IRENE, is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte. Participants in the multi-center study receive pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012).

 

The recently announced IRENE study builds on prior clinical data showing pelareorep-induced priming of an adaptive immune response in multiple breast cancer subtypes. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future registrational trials by facilitating study design and patient selection. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

 

Principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, commented, “The paucity of treatment options in metastatic triple-negative breast cancer combined with its aggressive clinical behavior results in a poorer prognosis when compared to other subtypes of breast cancer. This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option. I’m looking forward to getting this study underway to potentially make an impact in the lives of patients affected with metastatic triple-negative breast cancer.”

 

For more information about the IRENE study, refer to ClinicalTrials.gov (NCT04445844).

 

About IRENE

 

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

 

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

 

About Breast Cancer

 

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Pelareorep

 

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company Contact Kirk Look Chief Financial Officer 403.670.7658 KLook@oncolytics.ca

 

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 212.915.2564 tim@lifesciadvisors.com

 

Source:  Oncolytics Biotech^® Inc.

Multi-center trial to evaluate the safety and efficacy of pelareorep-anti-PD-1 combination therapy in triple-negative breast cancer, an indication of continued unmet medical need

 

Study builds on prior clinical data showing pelareorep-induced priming of an adaptive immune response in multiple breast cancer subtypes

 

Systemic pelareorep administration has the potential to increase the number of patients that are eligible for checkpoint inhibitor therapy

 

San Diego, CA and Calgary, AB – June 25, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), today announced a new investigator-sponsored triple-negative breast cancer (TNBC) study to be managed by Rutgers Cancer Institute of New Jersey The phase 2 trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC.

 

“We are very excited to evaluate pelareorep in TNBC, as prior clinical data show it has the potential to address a pressing unmet need in this challenging indication,” said principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School. “Checkpoint inhibitors targeting interactions between PD-L1 and PD-1, while commercially successful, are ineffective in up to 80% of TNBC patients. This is often due to an immunosuppressive tumor microenvironment. Checkpoint inhibitors are beneficial in patients who have upregulation of PD-L1 expression in the tumor environment. Clinical data show that systemic pelareorep administration can upregulate PD-L1 expression in tumors across multiple breast cancer subtypes, highlighting its potential to substantially increase the percentage of patients who respond to checkpoint inhibitor therapy. Through the IRENE study, we aim to explore how pelareorep-induced adaptive immune responses synergistically interact with PD-1 inhibition to improve patient outcomes in TNBC.”

 

The newly announced IRENE study represents an expansion of Oncolytics’ lead breast cancer program into a new disease subtype (TNBC). In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future pivotal studies by facilitating the patient selection process. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center, and is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte.

 

About IRENE

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

 

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

 

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the design, purpose, timing and anticipated benefits of the IRENE study; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company Contact Kirk Look, CFO Oncolytics Biotech Inc. 403-670-7658 klook@oncolytics.ca

 

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 212.915.2564 tim@lifesciadvisors.com

 

Source:  Oncolytics Biotech^® Inc.

therapy avelumab and improve outcomes in metastatic breast cancer

 

Study aims to validate T cell clonality as a biomarker of pelareorep response and enable advancement into a phase 3 registrational study

 

BRACELET-1 is being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer

 

San Diego, CA and Calgary, AB – June 23, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC),  today announced the first patient has been dosed in the Company’s phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer (mBC). The study, known as BRACELET-1, is being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business in the US and Canada as EMD Serono, and Pfizer Inc. (NYSE: PFE). Participants in the study receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck KGaA, Darmstadt, Germany and Pfizer’s anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio^®).

 

The randomized BRACELET-1 study is designed to support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment, by demonstrating pelareorep’s ability to induce a robust anti-tumor immune response in an identical patient population (patients with HR+/HER2- mBC). The ability of pelareorep-induced immune responses to enhance anti-PD-L1 therapy will also be evaluated through the inclusion of the paclitaxel-pelareorep-avelumab combination therapy cohort. Importantly, the trial also aims to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- mBC, which may aid in future registrational trial study design and patient selection.

 

For more information about the BRACELET-1 study, refer to ClinicalTrials.gov (NCT04215146).

 

About BRACELET-1

 

The BRACELET-1  (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti-PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study.  The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts.  A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

 

• Cohort 1 (n=15): paclitaxel
• Cohort 2 (n=15): paclitaxel + pelareorep
• Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio^®)

 

Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle.  Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle.  Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

 

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the design, aims and anticipated benefits of the BRACELET-1 study, and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Kirk Look Chief Financial Officer 403.670.7658 KLook@oncolytics.ca   Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 212.915.2564

tim@lifesciadvisors.com

 

Source:  Oncolytics Biotech Inc.

 

• Recently announced clinical data demonstrate pelareorep-induced priming of an
  adaptive immune response
• Pro-inflammatory effects of pelareorep observed across multiple breast cancer subtypes
• Data support further clinical development of pelareorep-anti-PD-L1 combination therapies

 

San Diego, CA and Calgary, AB –  June 4, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), today provided a recap of a Key Opinion Leader (KOL) call sponsored by Canaccord Genuity and held on June 2, 2020. The call focused on recently announced clinical data from Oncolytics’ AWARE-1 study presented at the European Society for Medical Oncology (ESMO) Breast Cancer Virtual Meeting 2020 and highlighted the ability of pelareorep to induce a pro-inflammatory tumor microenvironment across multiple breast cancer subtypes.

 

Featured on the KOL call was Dr. Aleix Prat, M.D., Ph.D., Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Chair of SOLTI and lead translational investigator of the AWARE-1 study.

 

“I am highly encouraged by the recently announced AWARE-1 data, which demonstrate the potential of pelareorep to address pressing unmet needs in multiple breast cancer subtypes and treatment settings,” said Dr. Prat. “Immunosuppressive tumor microenvironments are known to limit the efficacy of checkpoint inhibitor therapies and highlight the need for synergistic co-therapies to promote tumor inflammation. The data presented at the ESMO meeting show that pelareorep induces a rapid and persistent immune response and thus has the potential to address this critical need.  Importantly, the data also validate T cell clonality as a biomarker of pelareorep response, which may ultimately accelerate pelareorep’s approval by facilitating the efficient design of pivotal studies.”

 

The AWARE-1 study combines the appropriate intervention for each patient’s breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq^®), followed by surgery in early-stage breast cancer patients. Patients are biopsied on day one (followed immediately by treatment), then again on day three, and for a final time three weeks post-treatment (just prior to mastectomy). Biomarker data from the paired patient biopsies are then collected and analyzed.  At the time of data presentation at ESMO Breast Cancer, 13 patients had been enrolled in AWARE-1, and biopsy data were available on 6 of these.

 

Clinical findings highlighted during Dr. Prat’s discussion included:

 

• Intravenous administration of pelareorep led to robust, tumor-specific pelareorep replication.
• Pelareorep systemic administration increased tumor PD-L1 expression, infiltration of tumor immune lymphocytes, and CelTIL (a measurement of tumor-associated cellularity and tumor-infiltrating lymphocytes). These data demonstrate that pelareorep induces adaptive as well as innate immune responses and support the observed survival benefit in a previous randomized phase two study of pelareorep in metastatic breast cancer patients. Pelareorep-induced responses were both rapid (present three days after treatment) and persistent (remained through day twenty-one).
• Pelareorep-induced increase in tumor PD-L1 expression demonstrates the synergistic potential between pelareorep and checkpoint inhibitor therapies. Many patients are ineligible for (and fail to respond to) checkpoint inhibitor-based therapies due to an immunosuppressive tumor microenvironment and low PD-L1 expression.
• AWARE-1 data further support T cell clonality as a biomarker of pelareorep response. Peripheral T cell clonality correlated with changes in the tumor microenvironment as well as CelTIL, which is associated with favorable clinical response. These data highlight T cell clonality’s potential as a biomarker of pelareorep response and are consistent with data from a prior clinical study of pelareorep in pancreatic cancer. Use of T cell clonality as a predictive biomarker may facilitate the design of registrational trials and improve chances of trial success across multiple indications.
• Data suggest that pelareorep treatment has multiple therapeutic mechanisms in cancer. These mechanisms include the induction of an adaptive immune response, direct tumor cell killing, and induction of a durable immune memory effect against cancer cells. The multiple mechanisms of pelareorep may expand its clinical opportunity across multiple breast cancer subtypes (e.g. triple negative and HR+/HER2- breast cancer) and treatment settings (e.g. as an anti-PD-L1 co-therapy or neoadjuvant treatment).

 

Oncolytics would like to thank Dr. Prat for his time and insightful commentary, as well as Canaccord Genuity for hosting the call. A replay of the call can be found on the company website at https://ir.oncolyticsbiotech.com/events-presentations.

 

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

 

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

 

The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

 

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Michael Moore Investor Relations & Corporate Communications 858-886-7813 mmoore@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 212.915.2564 tim@lifesciadvisors.com

 

Source:  Oncolytics Biotech^® Inc.

Study continues enrollment in patients receiving Tecentriq combination

 

Clinical data to be presented at ESMO Breast in May

 

San Diego, CA and Calgary, AB – March 24, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced a favourable assessment from the Safety Committee following review of data from the window of opportunity study in early-stage breast cancer, known as AWARE-1.  Consistent with the safety run-in with patients receiving pelareorep and Tecentriq^®, Cohort 1 demonstrated widespread viral replication in the majority of tumors with the creation of a pro-inflammatory effect in the tumor microenvironment. No negative effects to healthy tissue were noted.

 

The Committee evaluated safety parameters from patients participating in the safety run-in phase of the trial, consisting of select patients from cohorts 2 and 3, along with the fully enrolled cohort 1, and determined there were no safety concerns.  The Committee also approved an amendment of the study to reduce the dose of Tecentriq to be consistent with the currently approved breast cancer dose of 840mg.  The study will continue to enroll patients and the Safety Committee will meet again for an additional pre-planned meeting. Cohorts 1 and 2 represent our target tumor type of HR+ / HER2- and data from these patients will inform the design of the planned phase 3.

 

“After reviewing the totality of safety data, including patients receiving pelareorep plus the standard of care and those also receiving Tecentriq, the Safety Committee for AWARE-1 confirmed no significant toxicity resulting from treatment,” said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics Biotech. “The study is continuing as planned, recruiting additional patients and examining the combination of pelareorep, plus the standard of care plus Tecentriq.  We look forward to presenting updated data at the ESMO Breast Cancer conference in May, which will describe meaningful changes to the tumor microenvironment, evidence of tumor infection, and of course, our biomarker correlated to immunogenic response and viral replication.”

 

About AWARE-1

 

AWARE-1 is an open label window-of-opportunity study in early stage breast cancer enrolling 38 patients into five cohorts:

 

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

 

The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

 

The study is being coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board.

 

About Breast Cancer

 

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

 

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

 

About Pelareorep

 

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About Oncolytics Biotech Inc.

 

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

 

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic; the planned continuation of the AWARE-1 study, including the recruitment of additional patients; the presentation of data at the ESMO Breast Cancer conference in May 2020, and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Michael Moore Investor Relations & Corporate Communications 858-886-7813 mmoore@oncolytics.ca   Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 212.915.2564 tim@lifesciadvisors.com

Source:  Oncolytics Biotech^® Inc.

Over 80% improvement in progression free survival in patients with low levels of CEACAM6

 

San Diego and Calgary, AB – January 27, 2020 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that a poster presentation highlighting statistically significant data demonstrating that CEACAM6 is a potential biomarker for pelareorep in the treatment of pancreatic cancer. The presentation was delivered at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco.

 

“We have potentially identified a second biomarker for pelareorep,” said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. “These results suggest that CEACAM6 levels can predict long term benefit in pancreatic cancer. We are working with potential industry partners and academic collaborators to verify this important finding not only in pancreatic cancer but potentially in other GI indications where this biomarker is linked to clinical outcomes”

 

The poster, CEACAM6 is a candidate biomarker for Reolysin^® (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), highlights data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer.  Data in the presentation associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer, with PFS increasing by more than 80%, from 5.72 months to 10.32 months (p=0.05).

 

“I’m extremely happy to see additional data come from this important study run by the Ohio State University Comprehensive Cancer Center,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech.  “This statistically significant result  suggests CEACAM6 may become an additional prognostic biomarker for pelareorep and could provide considerable clinical value as we investigate its potential in pancreatic and other GI cancers.”

 

CEACAM6 is differentially expressed in pancreatic adenocarcinoma cells.  High levels of CEACAM6 have previously been demonstrated to block viral trafficking in virally infected cells, thereby decreasing viral replication. Study investigators speculated that altered CEACAM6 levels may be predictive for pelareorep sensitivity and may serve as a biomarker.

 

Key data and conclusions:

 

CEACAM6 was the most differentially expressed gene with an eight-fold decrease in levels in long-term responders as compared to early progressors in patients receiving pelareorep.

 

Low levels of CEACAM6 mRNA expression were associated with prolonged PFS in pelareorep-treated patients (p=0.05). This treatment effect was not seen in non-pelareorep treated patients (p=0.35).

 

In pelareorep treated patients, CEACAM6 mRNA expression level was very influential with a hazard ratio of 1.54 (p=0.01), suggesting that one unit increase in CEACAM6, corresponds to an increase in the risk of progression and/or death by 54% in this arm. There was no significant relationship seen in non-pelareorep treated patients.

 

CEACAM6 may be included as a candidate biomarker of resistance to pelareorep and, in theory, could inhibit viral trafficking in tumor cells

 

The poster presentation was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona.  It can be found on the Posters & Publications page of the company’s website: https://www.oncolyticsbiotech.com/technology/posters-publications.

 

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype – turning “cold” tumors “hot” – through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Michael Moore Investor Relations & Corporate Communications 858-886-7813 mmoore@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 212.915.2564 tim@lifesciadvisors.com

 

 

Source:  Oncolytics Biotech^® Inc.

Statistically significant, near doubling of progression free survival

 

CEACAM6 – New prognostic biomarker candidate for pelareorep sensitivity

 

San Diego, CA and Calgary, AB –  January 22, 2019 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today stated that the previously announced abstract for a poster to be presented at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco, has been published.  The abstract highlights new biomarker data from the randomized study NCI 8601:  Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer.

 

The abstract, CEACAM6 is a candidate biomarker for Reolysin^® (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona.

 

Data in the abstract associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer, with PFS improving from 5.72 months to 10.32 months (p=0.05). This effect was not seen in non-pelareorep treated patients. Consequently, CEACAM6 may serve as a prognostic biomarker for sensitivity of pancreatic tumors to pelareorep treatment.  Additional data will be announced following the poster presentation.

 

Abstracts are available on the ASCO meeting library website at https://meetinglibrary.asco.org/.  The poster will be added to the Oncolytics corporate website shortly after the presentation.

 

Abstract ID:                       285103

Abstract Number:             746

Poster Board:                    M13

Abstract Title:    CEACAM6 as a candidate biomarker for pelareorep sensitivity in pancreatic adenocarcinoma (PDAC)

Session Information:       Poster Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer

Session Date & Time:      January 24, 2020 from 12:00 PM-1:30 PM & 4:30 PM-5:30 PM

 

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype – turning “cold” tumors “hot” – through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

 

Company Contact Michael Moore Investor Relations & Corporate Communications 858-886-7813 mmoore@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 212.915.2564 tim@lifesciadvisors.com

 

Source:  Oncolytics Biotech^® Inc

Pre-clinical and clinical data demonstrate synergies between pelareorep and the proteasome inhibitor carfilzomib through inflammation, apoptosis and tumor responses

 

Data provides scientific rationale supporting the ongoing phase 1b trial in multiple myeloma patients

 

San Diego, CA and Calgary, AB –  December 9, 2019 — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that a poster presentation was given over the weekend highlighting pre-clinical and clinical results of combining pelareorep with the proteasome inhibitor carfilzomib in the treatment of multiple myeloma. The presentation was given on Saturday, December 7 as part of the 2019 American Society of Hematology Annual Meeting & Exhibition.

 

The abstract, titled, “Proteasome Inhibitors Impair the Innate Antiviral Immune Response and Potentiate Pelareorep-Based Viral Therapy in Multiple Myeloma” describes synergies between proteasome inhibitors and pelareorep concerning immune cell changes and response in multiple myeloma patients.

 

“These findings demonstrate that pelareorep, in combination with carfilzomib, infects multiple myeloma cells, thereby providing a strong scientific rationale regarding immune cell changes,” said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics Biotech. “The combination of carfilzomib and pelareorep promotes expansion of killer T cells in patients on an ongoing phase 1b study and how it may lead to tumor response when pelareorep is combined with proteasome inhibitors. We are confident that pelareorep could add significant clinical value to the treatment of multiple myeloma patients with the combination of these agents. Our first data in patients from an ongoing study has been very encouraging and further data will be presented at subsequent clinical conferences.”

 

Key data and conclusions:

 

• Demonstrated that pelareorep treatment selectively infected multiple myeloma cells and not normal bone marrow cells
• Carfilzomib enhances reovirus entry, infection, and killing of multiple myeloma cells
• Reovirus significantly increases the frequency and activation of certain killer T cells, and increases the anti-tumor activity of immune cells in multiple myeloma
• Data supports that the combination of pelareorep, and carfilzomib potentiates the expansion of CD8+ killer T cells

 

The poster presentation was authored by Dr. Flavia Pichiorri, Associate Professor in the Judy and Bernard Briskin Center for Multiple Myeloma Research within the Hematologic Malignancies and Stem Cell Transplantation Institute at the City of Hope, et al. The poster can be found on the Posters & Publications page of Oncolytics’ website, https://www.oncolyticsbiotech.com/technology/posters-publications.

 

Title:                     Proteasome Inhibitors Impair the Innate Antiviral Immune Response and Potentiate Pelareorep-Based Viral Therapy in Multiple Myeloma

Number:             1816
Presenter:          Dr. Flavia Pichiorri
Program:             Oral and Poster Abstracts
Session:               652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster I

 

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

 

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype – turning “cold” tumors “hot” – through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

 

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

 

Oncolytics Contact Michael Moore Vice President, Investor Relations & Corporate Communications 858-886-7813 mmoore@oncolytics.ca
Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors 212.915.2564 tim@lifesciadvisors.com	Media Contact for Oncolytics Jason Spark Canale Communications 619-849-6005 jason@canalecomm.com

 

 

SOURCE:  Oncolytics Biotech^® Inc.