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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

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.


TSX:ONC - Post by User

Post by Quentin30on Nov 14, 2022 7:00pm
229 Views
Post# 35098285

Timing of Phase III for Panc

Timing of Phase III for PancJust for clarification. End of Phase II meeting will require a Type C meeting request, this will take 90 days. The end of Phase II meeting will inform what must be included in the Phase III design.

ONCY will need time to author their IND, which FDA could assess within 30 days.

So realistically, the earliest a Phase III or even Phase II/III for Panc could possibly start will be mid Q2 2023.

That may be of value to some here, and could certainly be an inflection point.
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