Post by
Noteable on Jun 28, 2023 12:53pm
PanCan's Precision Promise adaptive clinical trial program
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/
Comment by
Noteable on Aug 03, 2023 5:42pm
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/
Comment by
Noteable on Aug 16, 2023 2:30pm
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.
Comment by
Noteable on Oct 03, 2023 9:22pm
Accelerated Approval would be sought on the basis of surrogate endpoints such as ORR and/or mPFS.
Comment by
Noteable on Sep 26, 2023 10:10am
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.
Comment by
Noteable on Sep 26, 2023 10:15am
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.
Comment by
Noteable on Sep 26, 2023 10:35am
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.
Comment by
Noteable on Sep 26, 2023 5:35pm
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.