The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on MediLink Therapeutics (Suzhou) Co., Ltd.’s Phase I trial evaluating BNT326/YL202 (NCT05653752).
 
The decision follows the submission of a comprehensive response by MediLink, addressing the FDA’s concerns regarding safety data and incorporating additional risk mitigation measures.
 
BNT326/YL202 is a HER3-targeting antibody-drug conjugate (ADC) being developed in collaboration with BioNTech SE. The trial will now resume recruitment, focusing on dose levels no higher than 3 mg/kg, where the safety profile was deemed manageable and encouraging clinical activity was observed.
 
The FDA’s decision comes after MediLink observed a dose-dependent trend of treatment-related adverse events (TRAEs), including neutropenia and mucositis. These are common side effects of established chemotherapies and can increase the risk of serious infections.
 
In response to the emerging safety data, MediLink and BioNTech took proactive measures, such as pausing enrollment at higher dose levels and reducing doses for existing participants. Additionally, the companies updated the investigator brochure, informed consent, and clinical trial protocol to address TRAEs and implement further risk mitigation strategies.