The FDA has lifted the partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC).
This decision, announced on August 15, follows the submission of a complete response that includes data analysis, updated documentation, and additional risk mitigation measures, the company reported in an SEC filing.
The MediLink-sponsored trial evaluates the early-stage antibody-drug conjugate product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer or HR+/HER2-negative breast cancer.
The FDA has shared with ...
