Oncolytics Biotech Inc T.ONC

Alternate Symbol(s): ONCY

Healthcare Biotechnology

Oncolytics Biotech Inc. is a 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 phase 3 licensure-enabling 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 > Canaccord Fireside Chat & pelareorep's approval in mBC

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Comment by Noteableon Aug 13, 2023 9:06pm

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Post# 35586322

RE:RE:RE:RE:RE:RE:RE:Canaccord Fireside Chat & pelareorep's approval in mBC

Both Phase 3 clinical trials can benefit from the FDA's enhanced Accelerated Approval process and the Precision Pathways Act that provide for the quick and early approval of drugs based on surrogate endpoints like ORR and PFS. These surrogates are later validated post approval, with long term OS data that is collected from the Phase 3 clinical study that is run concurrently while the drug' is on the market with the early approval. So shareholders could be looking at FDA conditional approvals or an acquisition as early as Q4 2023 or Q1 2024.

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