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 9:47pm

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Post# 35533045

RE:RE:RE:Promising Pathways Act (PPA)

The Accelerated Approval (AA) process provides that a sponsor company have a Phase 3 planned, can show positive surrogate endpoints, such as ORR and PFS, and has initiated patient enrollment in the Phase 3 trial, which can happen in weeks or months after the sponsor company makes an AA request of the FDA.

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