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