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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 Noteableon Jun 24, 2024 4:26pm
140 Views
Post# 36103920

RE:How does Accelerated Approval work

RE:How does Accelerated Approval work June 24, 2024 - Bristrol Myers Squibb's KRAS inhibitor has been granted Accelerated Approval as part of a combination treatment for a subset of colorectal cancer (CRC) patients.

The approval is based on results from cohorts of the Phase 1/2 KRYSTAL-1 open-label study which evaluated KRAZATI. The study met its primary endpoint, with a confirmed ORR of 34% (n=94, 95% CI: 25-45) for KRAZATI with cetuximab, all of which were partial responses

The matter of particular interest is that BMS's drug Krazati was approved in combination with another drug, which is the pathway to a approval that ONCY's pelareorep is taking in combination with immune checkpoint inhibitors, bispecifics, ADC and CAR-T therapy, and small molecules like CDK 4/6 and PARP inhibitors. 

https://pmlive.com/pharma_news/bristol-myers-squibbs-krazati-combination-granted-fda-accelerated-approval-in-colorectal-cancer/


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