FDA slaps clinical hold on MediLink/BioNTech’s ADC drug trial

German biotech BioNTech (Nasdaq: BNTX) today announced that it has been informed by its partner, China’s MediLink Therapeutics (Suzhou), that the US Food and Drug Administration (FDA) has placed a partial clinical hold on a trial of their antibody-drug conjugate (ADC).

The study is a multicenter, open-label, first-in-human Phase I clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage ADC product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) or HR+/HER2-negative breast cancer. The partial hold affects the enrollment of new patients in the trial in the USA.

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