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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.


TSX:ONC - Post by User

Oncolytics Biotech Inc > MBC phase 3
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Comment by Noteableon Aug 20, 2023 11:58am
158 Views
Post# 35596923

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:MBC phase 3

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:MBC phase 3Biomarkers are used to identify the best treatment for a patient, to monitor the safety of a therapy, or to find out if a treatment is having the desired effect on the body.

Many biomarkers used today have been developed to be used in a specific disease or as part of the development program for a specific medical product. Under the FDA’s recently established Biomarkers Qualification Program, biomarkers shown to be useful indicators across different development programs may be designated by the FDA as qualified biomarkers.

The mission of the CDER Biomarker Qualification Program (BQP) is to work with external stakeholders to develop biomarkers as drug development tools. 

CelTIL score is a novel, combined biomarker based on stromal tumor-infiltrating lymphocytes and tumor cellularity and is determined in tumor biopsies involving anti-HER2 therapy.

According to the FDA, biomarkers and surrogate endpoints provide an early understanding of treatment benefit and underscores the importance of continued evaluation of both in a post-approval / post-market phase after products are approved based upon surrogate endpoints that have not been validated. This view appears to place pelareorep in a favorable position for an early approval Acelerated Approval in mBC and the need for ONCY to pursue the FDAs opportunity for early drug approval.

FDA Facts: Biomarkers and Surrogate Endpoints | FDA
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