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 > How does Accelerated Approval work

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Comment by Noteableon Nov 26, 2024 4:23pm

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RE:RE:RE:RE:RE:RE:How does Accelerated Approval work

With the pathwat to Accelerated Approval (AA) open and the FDA granting Replimmune's intratumorally (IT) delivered OV therapy Breakthrough Therapy Designation (BTD), ONCY's pelareorep 'second mouse' strategy leads the path towards gaining AA and BTD on ONCY's IV administered OV pelareorep, and in particular now gaining a much earlier AA than some think, as exampled through the now available BTD opportunity.

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