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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.


TSX:ONC - Post by User

Oncolytics Biotech Inc > Adlai Nortye
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Comment by Capitalistaon Sep 29, 2022 8:11am
198 Views
Post# 34994264

RE:RE:RE:Adlai Nortye

RE:RE:RE:Adlai Nortye
Noteable wrote: This could also suggest that ONCY (or acquirer) may be looking to file for an accelerated marketing approval for pelareorep with the FDA based on the collective results the IND-213, AWARE-1, Bracelet-1 and Goblet Phase 2 clinical trials which investigated the effectiveness of pelareorep + immune checkpoint inhbitors.

The Adlai Nortye trials were designed as monotherapy pelareorep with chemotherapy (paciltaxel) versus paciltaxel - which doesn't fit with an accelerated approval for the above synergistc pelareorep + ICI I/O combination therapy. 


I'm not sure I follow your logic here, Noteable.  Wouldn't the applicant just have to exclude the AN trial from the FDA application?  AN is an independent company working in a different regulatory environment.  Can you clarify? 

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