FDA Clears Path for MediLink's BNT326/YL202 Trial To Move Forward

The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on MediLink Therapeutics (Suzhou) Co., Ltd.’s Phase I trial of BNT326/YL202 (NCT05653752). This decision follows MediLink's detailed response, which addressed the FDA's safety concerns and included new risk mitigation strategies. BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC), is being developed in partnership with BioNTech SE. The trial will now resume recruitment, but only at dose levels up to 3 mg/kg, where the safety profile was manageable and clinical activity showed promise.

The FDA's decision follows MediLink's observation of a dose-dependent increase in treatment-related adverse events (TRAEs) such as neutropenia and mucositis, both common side effects of chemotherapy that can heighten the risk of severe infections. In response to these safety concerns, MediLink and BioNTech proactively paused enrollment at higher doses, reduced dosages for current participants, and updated trial documentation, including the investigator brochure, informed consent, and clinical trial protocol, to better address TRAEs and enhance safety measures.