RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsJune 18, 2024 - FDA halts BioNTech's ADC Phase 1 clinical trial due to safety issues.
The FDA has slammed the brakes on a trial of MediLink Therapeutics’ BioNTech-partnered antibody-drug conjugate (ADC) that has already seen three fatalities, with the agency citing a risk of “unreasonable and significant risk of illness or injuries.”
The German drugmaker announced in a SEC Commission filing on June 18, 2024 that the FDA has placed a phase 1 trial on partial hold over concerns that BNT326/YL202 “may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries.” This includes “providing additional information in the investigators brochure regarding the safety findings including grade 5 adverse events observed” in both the phase 1 study as well as a phase 2 trial of the ADC which, according to ClinicalTrials.gov, kicked off at the end of last year.
A grade 5 adverse event signifies a fatality.
https://www.fiercebiotech.com/biotech/fda-halts-trial-biontech-medilink-adc-over-significant-risk-illness