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 Feb 23, 2024 12:24pm

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RE:How does Accelerated Approval work

February 23, 2023 - European Medicines Agency (EMA) Committee for Medicianl Products for Human Use (CHMP) grants Accelerated Approval for a vaccine candidate based upon CHMP's decision that the vaccine candidate is of major interest for public health and therapeutic innovation.

Logic dictates that ONCY's pelareorep candidacy for use in combination with an immune checkpoint inhibitor, in the treatment of a rare disease with an unmnet medical need, namely L1 pancreatic (PDAC) cancer would be of major interest for public health and therapeutic innovation.

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