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 Apr 15, 2024 2:43pm

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Post# 35989952

RE:RE:RE:How does Accelerated Approval work

In the case of ONCY's biomarker driven registration studies, the number of enrolled patients for a Phase3/4 post approval confirmatory trial should be nominal due to the nature of the number of available patients with these Orphan / Rare conditions, and the urgency that having a serious cancer with an unment treatment need creates, such as with both advanced/metastatic pancreatic (PDAC) and breast cancers.

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