On June 17, 2024 BioNTech and its partner MediLink Therapeutics (Suzhou) Co., Ltd ("MediLink") reported that the U.S. Food and Drug Administration ("FDA") has placed a partial clinical hold on the multicenter, open-label, first-in-human Phase 1 clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage antibody-drug conjugate ("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 (Press release, BioNTech, JUN 17, 2024, View Source [SID1234645735]). The partial hold affects the enrollment of new patients in the trial in the U.S.

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The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries. In order to address the FDA requests, certain steps need to be taken, including reviewing clinical and safety data, sharing available pharmacological data with the Agency and providing additional information in the investigators brochure regarding the safety findings including grade 5 adverse events observed in studies YL202-INT-101-01 and YL202-CN-201-01. MediLink has taken actions to pause enrollment of new patients in the U.S. and address the FDA requirements.