Hedley, did you see this BioNTech announcement from 17 June? Maybe the FDA is getting tough again.
“BioNTech SE has been informed by its partner MediLink Therapeutics (Suzhou) Co., Ltd (“MediLink”) that the U.S. Food and Drug Administration (“FDA”) has placed a partial clinical hold on the multicenter, open-label, first-in-human Phase 1 clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage antibody-drug conjugate (“ADC”) product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (“EGFR”)-mutated non-small cell lung cancer (“NSCLC”) or HR+/HER2-negative breast cancer. The partial hold affects the enrollment of new patients in the trial in the U.S.
The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries. In order to address the FDA requests, certain steps need to be taken, including reviewing clinical and safety data, sharing available pharmacological data with the Agency and providing additional information in the investigators brochure regarding the safety findings including grade 5 adverse events observed in studies YL202-INT-101-01 and YL202-CN-201-01. MediLink has taken actions to pause enrollment of new patients in the U.S. and address the FDA requirements.”
Hedley, did you see this BioNTech announcement from 17 June? Maybe the FDA is getting tough again.
“BioNTech SE has been informed by its partner MediLink Therapeutics (Suzhou) Co., Ltd (“MediLink”) that the U.S. Food and Drug Administration (“FDA”) has placed a partial clinical hold on the multicenter, open-label, first-in-human Phase 1 clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage antibody-drug conjugate (“ADC”) product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (“EGFR”)-mutated non-small cell lung cancer (“NSCLC”) or HR+/HER2-negative breast cancer. The partial hold affects the enrollment of new patients in the trial in the U.S.
The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries. In order to address the FDA requests, certain steps need to be taken, including reviewing clinical and safety data, sharing available pharmacological data with the Agency and providing additional information in the investigators brochure regarding the safety findings including grade 5 adverse events observed in studies YL202-INT-101-01 and YL202-CN-201-01. MediLink has taken actions to pause enrollment of new patients in the U.S. and address the FDA requirements.”
Thanks Alan - I didn't see that, so good catch. Did you see this: BioNTech—an illusonary company created by Bill Gates & Pfizer to scam the world - https://open.substack.com/pub/hedleyrees/p/biontechan-illusonary-company-created?r=xoehy&utm_campaign=post&utm_medium=web BioNTech doesn't have a snowballs chance of passing this kind of scrutiny. I think with the CDC out of its hair, runnning interference on regulatory matters, FDA is going to get onto the front foot. I have already point out that the Wyeth Biopharma inspection in 2021 had 13 serious safety observations, see: https://open.substack.com/pub/hedleyrees/p/fda-foia-control-2024-5142-missing?r=xoehy&utm_campaign=post&utm_medium=web Nice to heasr from you again, Alan :O)