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 > New Press Release - Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program

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Comment by Noteableon Jun 29, 2024 12:23pm

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RE:RE:RE:RE:RE:RE:RE:New Press Release - Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program

That said ... PFS is considered by the FDA to be a "validated" surrogate endpoint that can also lead times an Accelerated Approval.

CelTil is a novel biomarker/surrogate endpoint that applies breast, pancreatic, CRC and anal caner which can lead to Accelerated Approval particularly involving pelareorep in combination with ICIs, such as Tecentriq.

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