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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

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.


TSX:ONC - Post by User

Comment by fasttrack5on Jul 18, 2024 2:06pm
61 Views
Post# 36138756

RE:RE:FDA guides on how AA can be converted to full approval.

RE:RE:FDA guides on how AA can be converted to full approval.
Noteable wrote: July 18, 2024 - The FDA turns down Agenus’ plans to seek accelerated approval for a colorectal cancer combination. Agenus is using a combination of its CTLA-4 blocking antibody botensilimab and PD-1 candidate balstilimab.

Agenus said the FDA discouraged a filing for accelerated approval because of its belief objective response rates may fail to translate into survival benefit.  

No biomarker work appears to have been conducted or  submitted.


In phase 1, Agenus saw a 23% response rate that translated into an estimated median overall survival of 21.2 months. The biotech made the estimate after a median of 13.6 months of follow-up. The median follow-up in the phase 2 cohorts ranges from 5.5 months to 9.5 months. 

The phase 2 data are immature, though. And while Agenus plans to keep talking to the FDA as the data matures, the company faces the prospect of having to run a phase 3 study before it can seek approval.


https://www.fiercebiotech.com/biotech/fda-wrecks-agenus-accelerated-approval-plan-triggering-push-partner-cancer-combination

What about our ONC:)
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