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 > Clinical Trial Size in Orphan and Rare Diseases

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Comment by Noteableon Dec 04, 2023 9:16am

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Post# 35766724

RE:RE:RE:RE:Clinical Trial Size in Orphan and Rare Diseases

For further distinction between Breakthrough Therapy and FastTrack designation, Breakthrough Therapy designation is requested by the drug company.

Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, and the FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request.

ONCY has already received FDA FastTrack designation.

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