FDA Clears BioNTech-MediLink ADC Trial to Resume with Reduced Doses

FDA Approval:
The FDA has lifted the partial clinical hold on BioNTech and MediLink’s Phase I trial of BNT326/YL202, allowing the trial to resume with lower, safer doses.

Dose Adjustment:
The trial will focus on dose levels not exceeding 3 mg/kg, where the treatment has shown a manageable safety profile and encouraging clinical activity.

Safety Concerns:
The hold was due to concerns over dose-dependent treatment-related adverse events, including neutropenia and mucositis, which are known risks associated with established chemotherapies.

Proactive Measures:
MediLink and BioNTech took proactive measures, such as halting patient enrollment in higher dose cohorts and reducing doses for enrolled participants at higher levels.

Clinical Development:
With the FDA’s approval, MediLink and BioNTech will resume clinical development under revised guidelines, ensuring patient safety while exploring the potential of BNT326/YL202.

Stock Impact:
BNTX stock is up 1.10% to $86.13 following the announcement.