Oncolytics Biotech Inc ONCY

Primary Symbol: T.ONC

Healthcare Biotechnology

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. 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. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.

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Oncolytics Biotech Inc > Pelareorep in 3rd line HR+/HER2 negative breast cancer

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Comment by Noteableon Sep 17, 2024 9:50am

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Post# 36226974

RE:RE:RE:RE:RE:RE:RE:Pelareorep in 3rd line HR+/HER2 negative breast cancer

ONCY has unequivocally stated that it would be seeking Accelerated Approval in this "adaptive" Phase2b->Phase3->Confirmatory trial given that the surrogate endpoint of progression free survival (PFS) will be the primary objective. ONCY has the capacity to conduct this trial on its own OR a Big Pharma may become involved instead.

An Accelerated Approval request can be made as early as the end of this year (2024) on the strength of the maturing overall survival (OS) Bracelet-1 data, as the expanded Phase2->Phase3 study is based off the Bracelet-1 Phase 2 study.

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