Oncolytics Biotech Inc T.ONC

PanCan's Precision Promise adaptive clinical trial program

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IMMray PanCan-d test is involved with PanCan's Early Detection Initiative.

https://pancan.org/research/early-detection-initiative/  

https://pancan.org/news/new-early-detection-blood-tests-what-to-know/

[ As aside Illumina had  attempted to acquire Grail for US$ 7.1 Billion but the merger has been overturned by the FTC with the FTC's issuance of a divestiture order. Pfizer faces the same challenge by the FTC with Pfizer's attempt to acquire Seagen for US$43 Billion ]

https://www.ftc.gov/news-events/news/press-releases/2023/04/ftc-orders-illumina-divest-cancer-detection-test-maker-grail-protect-competition-life-saving

Precision Promise is focused around providing an adaptive clinical trial program to accelerate new treatment options in pancreatic patients.

https://pancan.org/research/precision-promise/

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PanCan's Precision Promise clinical trial program is focused around providing an adaptive clinical trial program to accelerate new treatment options in pancreatic patients. https://pancan.org/research/precision-promise/ ONCY's June 22, 2023 announcement that PanCan has selected ONCY's pelareorep for a Phase 3 clinical trial program, will serve to support approval of pelareorep in

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" Julie Fleshman, JD, MBA, President and CEO of PanCAN commented, "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising

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In 2022 PanCan spent $38 Million per year out of a $52 Million annual budget on clinical trial programming with the "Precision Promise adaptive clinical trial statistical design being created by Berry Consultants, the world experts in the Bayesian approach to medical statistics." https://pancan.org/about-us/financial-information/archived-annual-reports/impact-report-2022/

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PanCan's and ONCY's pelareorep approval timelines for pancreatic cancer and mBC should be positively impacted by the FDA's determination to move towards an Accelerated Approval process that is tied directly to the FDA's Operation Warp Speed project.  

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Precision Promise is focused around providing an adaptive clinical trial program to accelerate new treatment options in pancreatic patients.   https://pancan.org/research/precision-promise The Precision Promise study has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel

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Accelerated Approval would be sought on the basis of surrogate endpoints such as ORR and/or mPFS.

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June 22, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents

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ONCY has also been granted PanCansTherapeutic Accelerator Award (TAA). To achieve this, ONCY was competitively selected for the TAA which provides grants of up to $5 million to incentivize pharma and biotech companies to prioritize new pancreatic cancer therapies and conduct early-stage (Phase 1 and 2) clinical trials for these therapies.

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Oncolytics will allocate the additional $5 million Therapeutic Accelerator Award (TAA) funds to ongoing research focused on a clinical trial with pelareorep in combination with modified Folfirinox chemotherapy with or without an immune checkpoint inhibitor. 

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All of PanCans initiatives granted to ONCY can be rolled over to ONCYs Big Pharma acquirer, thus offering a further incentive for a Big Pharma take-over.

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Think GOBLET data and Accelerated Approval with PanCan Precision Promise Phase 3 trial as the confirmatory trial that satisfies the FDA's post approval requirements.

[canadafan]

The ball is starting to roll. The shorts better start to cover or pay big time. A $5 million grant? Not huge $$ BUT HUGE afirmation of the opportunity to move Pela forward. About a month agao there was an institutional buy-in for $17 million. Now $5 million from a grant. These are larger outsiders doing a lot of due dilligence. I expect yet another N.R. tomorrow am, before the fireside chat. No