Oncolytics Biotech Inc ONCY

Primary Symbol: T.ONC

Healthcare Biotechnology

Oncolytics Biotech Inc. is a 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 phase 3 licensure-enabling 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 > Conference Call

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Comment by Noteableon Aug 01, 2024 6:19pm

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Post# 36159359

RE:RE:RE:Conference Call

FDA current guidance on surrogate endpoints (biomarkers) in solid tumors like breast cancer

"Whether tumor measures such as ORR or PFS are used as an accelerated approval or traditional approval endpoint will depend on the disease context and the magnitude of the effect, among other factors"

https://www.fda.gov/media/71195/download

https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure

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First Nations contributions attract investor interest