Pelareorep Along With Checkpoint Inhibitors Proving Critically Important for Early Stage Breast Cancer

Palm Beach, FL –December 9, 2020 – In the breast cancer therapy market, the rise in the healthcare awareness among individual’s disease and treatment, early detection of the cancer, better surgical and medical treatment, R&D initiatives, and technological advancement are the factors driving the growth of the market. Breast carcinoma had affected many women in North America. It was estimated that about 500 women are diagnosed in the U.S. each day with breast carcinoma. A sedentary lifestyle and genetic mutation are the factors associated with the risk of breast carcinoma in the region, leading to rising in demand for breast carcinoma treatments. According to the current analysis of Reports and Data, the global Breast Cancer Therapy Market was valued at USD 19.02 billion in 2018 and is expected to reach USD 40.47 billion by the year 2026, at a CAGR of 10.6%.   Breast cancer is a tumor that is found in the mammary tissue. A lump is mostly seen in the breast; It shows symptoms like change in the shape, a newly-inverted nipple, or a red or scaly patch of skin and fluid coming from the nipple. WHO had signified that breast cancer affects about 2.1 million women every year and is the primary cause of deaths associated with malignancy.   Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX), IGM Biosciences, Inc. (NASDAQ: IGMS), Ampio Pharmaceuticals, Inc. (NYSE: AMPE), Bristol Myers Squib (NYSE: BMY).


A report from Grand View added that the global breast cancer drugs market size was valued at USD 16.98 billion in 2017 and is expected to register at a CAGR of 10.7% through 2025. Rising prevalence of the disease along with emerging novel therapies are some of the major factors likely to drive the market. Early detection of breast cancer is a key to effective management of the disease.  “Early detection can lead to desired outcomes including increased survival rate, number of treatment options, and improved quality of life. According to an article 2018 Research Fast Facts published by Susan G. Komen, early detection and regular screening with mammography can lower the death rate by 30%.”  The report continued; “Increasing awareness and presence of established R&D infrastructure are among the key factors contributing to growth of the market in North America… Rising awareness about the benefits of early detection of cancer has driven the U.S.-based companies to make considerable investments in the development of targeted therapy drugs.”


Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics and SOLTI Report Clinical Synergy of Pelareorep with Checkpoint Inhibitors at the 2020 San Antonio Breast Cancer Symposium – Oncolytics Biotech® 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.”    Read this full press release and more news for ONCY at:    


Other recent developments in the biotech industry of note include:


Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) recently announced that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.


In the SOLOIST study, the primary endpoint was achieved with a hazard ratio (HR) of 0.67 (p<0.001) in people with type 2 diabetes and a recent hospitalization for worsening heart failure. In the SCORED study, the primary endpoint was achieved with a hazard ratio of 0.74 (p<0.001) in people with type 2 diabetes and chronic kidney disease with an estimated glomerular filtration rate (eGFR) of 25 to 60 ml/minute per 1.73 m² of body-surface area.


IGM Biosciences, Inc. (NASDAQ: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, recently announced the presentation of preliminary clinical results from the Company’s Phase 1 trial evaluating IGM-2323, a bispecific IgM antibody targeting CD20 x CD3, at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The data was featured today in a poster presentation titled “Preliminary Results of a Phase 1 Dose Escalation Study of the First-in-Class IgM Based Bispecific Antibody IGM-2323 (anti-CD20 x anti-CD3) in Patients with Advanced B-Cell Malignancies” (Abstract number 1142).


The multicenter, open-label Phase 1 dose escalation trial is intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell non-Hodgkin’s lymphoma (NHL). As of October 30, 2020, the data cutoff date for the presentation, 16 patients were enrolled and treated at escalating dose levels of IGM-2323. Dose escalation continues in the study toward the anticipated recommended Phase 2 dose (RP2D) range of between 100 and 1000 mg.


Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, recently announced that its AP-014 Phase I inhaled Ampion™ clinical study in COVID-19 patients is proceeding to full open enrollment following clearance by the Safety Monitoring Committee (SMC), which found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups. The trial can now accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment.


“The primary goal of this trial is to confirm the safety of inhaled Ampion, so we are pleased the SMC found no concerns after treatment of the first sets of patients,” Michael Macaluso, President and CEO of Ampio Pharmaceuticals. “The enrollment of patients will proceed quickly, perhaps doubling the number of patients enrolled by the end of today.


Bristol Myers Squib (NYSE: BMY) recently announced new results from the QUAZAR® AML-001 study presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, evaluating Onureg® (azacitidine tablets; CC-486), an oral hypomethylating agent, as a treatment for adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy. Results demonstrated treatment with Onureg improved overall survival (OS), the primary endpoint of the study, as well as showed clinical benefit across other key secondary endpoints, compared to placebo, in patients with AML in first remission.


“These analyses from the QUAZAR® AML-001 study provide further insight into the clinical activity of Onureg and its potential role in the treatment paradigm of patients with acute myeloid leukemia in first remission following intensive chemotherapy,” said Andrew Wei, MBBS, Ph.D., QUAZAR® AML-001 lead investigator, Alfred Hospital and Monash University, Melbourne, Australia. “Persistence of acute myeloid leukemia is frequently measurable after intensive chemotherapy, and these new analyses from the pivotal trial demonstrate that Onureg can improve survival in patients with or without measurable residual disease, and across a range of consolidation cycles.”


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