Oncolytics Biotech Inc T.ONC

Alternate Symbol(s): ONCY

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 > Promising Pathways Act (PPA)

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Comment by Noteableon Jul 09, 2023 9:30pm

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Post# 35533038

RE:RE:Promising Pathways Act (PPA)

The PPA provides for a provisional approval without the initial need for surrogate endpoints and without Phase 3 trial. However while the provisional approval is in effect, data from real world evidence (RWE) and surrogate endpoints can be collected over a period of 2 to 8 years and then subsequently submitted to the FDA for full product approval.

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