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 and immunomodulatory drugs that will help advance pelareorep in 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.
Collaborations & Supply Agreements
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.
Celgene & Myeloma UK
We are working with Celgene and Myeloma UK, a cancer charity focused on improving quality of life for myeloma patients, on an immunotherapy trial that aims to treat relapsing myeloma patients by influencing the immune system.
MUK eleven is a first-of-its-kind immunotherapy trial that aims to modulate the immune system to target myeloma. The trial, run through the Myeloma UK Clinical Trial Network (CTN) in collaboration with charity Myeloma UK, the University of Leeds, Oncolytics and Celgene, launched in March 2017 and began enrolling patients in September 2017.
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.