FDA Places Partial Clinical Hold on BioNTech’s Anti-CTLA-4 Antibody Trial

Partial Clinical Hold:
The FDA has placed a partial clinical hold on a Phase 3 trial of an anti-CTLA-4 antibody developed by OncoC4 and its partner BioNTech.

Reason for Hold:
The hold was initiated due to concerns over the safety of the drug, although specific details were not disclosed in the available information.

Impact on Trial:
The partial hold means that enrollment of new patients in the trial has been paused, but existing patients may continue to receive treatment under certain conditions.

Previous Holds:
BioNTech has faced similar issues with another drug, BNT326/YL202, an antibody-drug conjugate (ADC) that was placed under a partial clinical hold in June 2024 due to patient deaths and significant risk of illness or injuries at higher doses. This hold was later lifted in August 2024 after the company amended the trial procedures to include additional risk mitigation measures.

Collaboration:
BioNTech and MediLink Therapeutics have a strategic collaboration and licensing agreement to develop ADCs targeting cancer, with BioNTech having rights to market the ADCs globally outside of the Greater China region.