Oncolytics Biotech Inc ONCY

Primary Symbol: T.ONC

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 22, 2024 12:44pm

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

November 21, 2024 - OV company Replimmune's intratumoral (IT) delivered virus has been granted FDA Breakthrough Therapy designation made under the Accelerated Approval pathway in combination with immune checkpoint inhibitor (ICI) nivolumab (Opdvo) in the treatment of patients with advanced melanoma who previously received an anti-PD-1 containing regimen.

https://www.biospace.com/press-releases/replimune-receives-breakthrough-therapy-designation-for-rp1-and-submits-rp1-biologics-license-application-to-the-fda-under-the-accelerated-approval-pathway

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Advancing flagship Ishkõday Gold Project in Ontario