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 > Panc Biomarker Presentation at ASCO GI 18-20 Jan 2024

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Comment by Noteableon Dec 31, 2023 11:17pm

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RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Panc Biomarker Presentation at ASCO GI 18-20 Jan 2024

The FDA doesn’t “have to get to 100% certainty between an accelerated approval endpoint and a clinical endpoint," Marks added.

“If that were the case, there wouldn't be a difference, then we wouldn't have accelerated approval,” he said. The agency can mitigate uncertainty by “using science to the fullest extent," according to Marks—be it available animal data or strong human biomarkers related to, for example, the expression of a particular protein.

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