Oncolytics Biotech Inc T.ONC

FDA comments on biomarkers as surrogate endpoints for AA

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March 21, 2023 - ".... for these gene therapies to make it through clinical trials in a “relatively facile manner”, the agency has to make use of what it has at its disposal to grant the therapies accelerated approval. This includes using surrogate endpoints like biomarkers to measure expected clinical benefit.

After accelerated approval is granted, the companies would then be required to confirm the therapy’s safety and efficacy through trials with measured endpoints. "

https://www.biospace.com/article/fda-official-backs-accelerated-approval-for-gene-therapies-ahead-of-sarepta-s-dmd-adcomm/

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Take what the FDA says about obtaining an accelerated approval with a specific cancer therapy and generally apply that to all cancer therapies with predictive and prognostic biomarkers lookiing at an accelerated approval, like ONCY would be with pelareorep.

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" Physicians, scientists, and regulators are pushing innovation to run clinical trials that are efficient, fast, and with high data quality. An example of this is how the measures of “success” (endpoints) have evolved from overall survival (OS), progression-free survival (PFS), or tumor measurements (overall response rate — ORR) to start including “surrogate endpoints”: biomarkers, quality of

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March 07, 2023 - Tumor infiltrating lymphocytes (TILs), reflect the local tumor microenvironment and may prove to be a superior endpoint in cancer vaccine/oncolytic virus trials. TILs are lymphocytes that have left the bloodstream, migrated to a tumor, and are at the right time able to recognize and kill cancerous cells . At the site of the tumor, subsets of TILs interact with each other and

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The journey of tumor-infiltrating lymphocytes as a biomarker in breast cancer: clinical utility in an era of checkpoint inhibition Highlights • TILs is a strong prognostic biomarker in some breast cancer subtypes in early-stage setting. • Our method of quantifying TIL published 5+ years ago has been standardized, is reproducible, and has been adopted

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https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-ord-shs?threadid=35837395

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  The journey of tumor-infiltrating lymphocytes (TiLs) as a biomarker in breast cancer: clinical utility in an era of checkpoint inhibition   Highlights • TILs is a strong prognostic biomarker in some breast cancer subtypes in early-stage setting.   • Our method of quantifying TIL published 5+ years ago has been standardized, is reproducible, and has been adopted

[Noteable]

 Tumor infiltrating lymphocytes (TILs), reflect the local tumor microenvironment and may prove to be a superior endpoint in cancer vaccine/oncolytic virus trials. TILs are lymphocytes that have left the bloodstream, migrated to a tumor, and are at the right time able to recognize and kill cancerous cells . At the site of the tumor, subsets of TILs interact with each other and with other

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Posted last year ... March 07, 2023 - Tumor infiltrating lymphocytes (TILs), reflect the local tumor microenvironment and may prove to be a superior endpoint in cancer vaccine/oncolytic virus trials.   TILs are lymphocytes that have left the bloodstream, migrated to a tumor, and are at the right time able to recognize and kill cancerous cells . At the site of the tumor, subsets of TILs

[Noteable]

March 21, 2023 - ".... for these gene therapies to make it through clinical trials in a “relatively facile manner”, the agency has to make use of what it has at its disposal to grant the therapies accelerated approval. This includes using surrogate endpoints like biomarkers to measure expected clinical benefit. After accelerated approval is granted, the companies would then be