Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC)

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Oncolytics Biotech® Announces Investigator Sponsored Phase 2 Trial Evaluating Pelareorep-anti-PD-1 Combination Treatment in Triple-Negative Breast Cancer

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.

Oncolytics Biotech® Doses First Patient in Phase 2 BRACELET-1 Study Evaluating Pelareorep-Based Combination Therapies in Metastatic Breast Cancer

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.

 

Oncolytics Biotech® Provides Recap of Key Opinion Leader Call Highlighting the Induction of Rapid and Persistent Immune Responses with Systemic Pelareorep Treatment
  • 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.

Oncolytics Biotech® Announces Favorable AWARE-1 Safety Update

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.

Oncolytics Biotech® Announces Statistically Significant Data Demonstrating the Potential of CEACAM6 as a Prognostic Biomarker for Pelareorep in the Treatment of Pancreatic Adenocarcinoma

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.

Oncolytics Biotech® Announces Publication of an Abstract for the 2020 Gastrointestinal Cancers Symposium Highlighting CEACAM6 as a Potential Prognostic Biomarker Candidate for Pancreatic Cancer

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

Oncolytics Biotech® Announces Positive Multiple Myeloma Data Presented at the 61st Annual Meeting & Exposition of the American Society of Hematology

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.

About Oncolytics Biotech


Innately Adaptive™

 

Oncolytics Biotech Inc. is developing pelareorep, a safe and well-tolerated intravenously delivered immuno-oncolytic virus (IOV) that kills cancer through a unique mechanism of action with two components, selective tumor lysis and activation of the innate and adaptive immune systems, creating an inflamed phenotype to treat a variety of solid tumors and hematological malignancies.

 

Developing Potential Treatments for a Variety of Tumor Types

 

Oncolytics Biotech Inc. is developing an intravenously delivered immuno-oncolytic virus called pelareorep, for the treatment of solid tumors and hematological malignancies. Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus that: 1) induces selective tumor lysis, and 2) promotes an inflamed tumor phenotype through innate and adaptive immune responses. Our clinical development plan is based on these two components of the mechanism of action, with a focus on obtaining regulatory approval as soon as possible.

 

Partnering, Collaborating & Combining Towards the Future

 

Oncolytics will grow through partnerships, collaborations and combinations, including:

 

  • Co-development agreement with Pfizer & Merck KGaA to study their PD-L1 checkpoint inhibitor Bavencio® in combination with pelareorep in HR+ /HER2- metastatic breast cancer.
  • Master Supply Agreement with Roche to supply Tecentriq® – their PD-L1 checkpoint inhibitor – for Oncolytics’ clinical development program. This was put to use immediately in the AWARE-1 study in breast cancer, a collaboration with the cooperative group SOLTI
  • Combination studies with Merck’s PD-1 checkpoint inhibitor Keytruda® in both multiple myeloma and pancreatic cancer.
  • Combination study with Bristol-Myers Squibb’s PD-1 checkpoint inhibitor Opdivo® in multiple myeloma.
  • Partnership with Adlai Nortye in China to develop pelareorep for metastatic breast cancer, as well as potentially additional indications

 

We continue to investigate further collaboration and partnership opportunities, particularly with checkpoint inhibitors and other immuno-oncology drugs, that will help us to advance pelareorep in the adjuvant setting.

 

Manufacturing

 

Pelareorep is currently being manufactured at commercial scale in its final formulation under a commercial supply agreement with MilliporeSigma.

 

Clinical Development Plan

 

Oncolytics is currently focused on immunotherapy combinations, including our studies with Bavencio®, Keytruda®, Opdivo® and Tecentriq®.

 

Our clinical development plan is based on pelareorep’s broad applicability to boost the effectiveness of a range of immunotherapies – with an immediate focus on checkpoint inhibitors – across multiple cancer indications. The primary objective is to obtain regulatory approval for pelareorep as quickly as possible and is based on our compelling metastatic breast cancer survival data, our synergies with checkpoint approved inhibitors and our biomarker. The second objective is to expand pelareorep into commercially valuable new treatment areas including other immunotherapy agents in collaboration with pharmaceutical partners.

 

We are excited to work with Pfizer, Merck KGaA, Merck, Bristol-Myers Squibb and Roche with their checkpoint inhibitors, and look forward to developing our programs to evaluate the efficacy and safety in our clinical studies targeting metastatic breast cancer, early stage breast cancer, multiple myeloma and pancreatic cancer.   There is great potential to eventually work with additional immunotherapies in additional indications and this will only drive the potential for treatment with pelareorep.

 

Collaborators

 

Based on the Company’s Clinical Development Plan, Oncolytics is investigating potential partnerships for its phase 3 registration program in metastatic breast cancer (mBC), as well as additional collaborations with checkpoint inhibitors that will help advance pelareorep in different indications and disease states, including the adjuvant setting.

 

Partnering

 

We are working with Adlai Nortye, a biopharmaceutical company focused on discovering and developing important new treatments for cancer and metabolic diseases, to advance our phase 3 registration program in mBC and to leverage their distinct experience and expertise in drug development and commercialization in China, Hong Kong, Macau, Singapore, South Korea and Taiwan. Under the terms of the agreement, Adlai Nortye has exclusive development and commercialization rights to pelareorep for all indications in these territories.

 

Co-Development

 

Oncolytics entered into a co-development agreement with Pfizer and Merck KGaA to develop pelareorep in combination with paclitaxel and Bavencio®, a human anti-PD-L1 antibody, for the treatment of hormone-receptor positive, human epidermal growth factor 2-negative (HR+ / HER2-) metastatic breast cancer. Oncolytics and Pfizer will share costs associated with the phase 2 clinical trial called BRACELET-1 (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti-PD-L1 and Paclitaxel), an open label study that will enroll 45 patients into three cohorts with 15 patients per cohort: paclitaxel alone, paclitaxel in combination with pelareorep and paclitaxel in combination with both pelareorep and avelumab. The study will examine the expression of immune-related biomarkers to identify changes in T cell clonality between pre-treatment and on-therapy biopsies to confirm our previously identified biomarker and is designed to assess efficacy in terms of overall response rate at week 16 per RECIST 1.1 and iRECIST. The safety of the combination will also be evaluated.

 

Collaborations & Supply Agreements

 

SOLTI

The Window of Opportunity (WOO) study in breast cancer, in collaboration with SOLTI, an academic research group dedicated to clinical and translational research in breast cancer, is being sponsored by Oncolytics and facilitated by SOLTI. The WOO study is in the neoadjuvant setting for breast cancer where patients will receive the appropriate standard of care for their cancer subtype plus pelareorep with or without the anti-PD-L1 cancer immunotherapy atezolizumab (Tecentriq®). The study will be 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. SOLTI has a network of more than 300 professionals, mostly medical oncologists, in over 80 hospitals in Spain, Portugal, France and Italy. Final study design and other details will be announced upon enrollment of the first patient, expected early 2019.

 

Roche

Oncolytics entered into a Master Clinical Supply Agreement with Roche to supply atezolizumab (Tecentriq®) for use in the company’s clinical development program. The supply agreement enables Oncolytics to further investigate pelareorep’s impact on cancer treatments in combination with atezolizumab and has already been incorporated into the company’s clinical program via the SOLTI WOO study in breast cancer. Data from studies with Tecentriq will broaden Oncolytics’ experience with the entire drug class as the company looks to demonstrate the impact of pelareorep with checkpoint inhibitors. Under this five-year Master Clinical Supply Agreement, Roche will supply Tecentriq for the proposed clinical trial with both parties having access to the clinical data.

 

Combinations

 

Merck

Oncolytics is combining pelareorep with Merck’s anti-PD-1, pembrolizumab (Keytruda®), in two Investigator Sponsored Trials (IST’s). The goal is to expand the use of checkpoint inhibitors as anti-cancer agents by promoting an inflamed phenotype in the tumor or turning cold tumors hot.

 

The first study is in second line pancreatic cancer run by Dr. Devalingham Mahalingam. It will enroll approximately 40 patients with advanced pancreatic cancer and be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

 

The second study, in collaboration with the Keck School of Medicine of University of Southern California (USC), is in multiple myeloma. This study, facilitated by Dr. Kevin Kelly, Associate Professor of Clinical Medicine, continues to build on the Company’s I-O program by combining proteasome inhibitors and pelareorep to demonstrate an increase of PD-L1 expression on multiple myeloma cells and recruitment of T-cells to the bone marrow.

 

Bristol-Myers Squibb

Oncolytics is combining pelareorep and nivolumab (Opdivo®) with a proteasome inhibitor for patients with relapsed/refractory multiple myeloma. The study will be facilitated by Craig C. Hofmeister, MD, MPH at Emory University and Douglas Sborov MD, MS at the University of Utah and expands on Oncolytics’ strategy of investigating the importance of systemic pelareorep administration followed by checkpoint blockade. This combination study will not only help demonstrate the specific role of pelareorep in promoting an inflamed phenotype, it should also help demonstrate how the virus can promote responses to checkpoint blockade in cold tumors.

 

Source:  https://www.oncolyticsbiotech.com/

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