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# Partial Hold on BioNTech/Medilink Trial
- URL: https://www.fdaweb.com/partial-hold-on-biontech-medilink-trial/
- Published: 2024-06-17T12:00:00.000Z
- Updated: 2026-09-14T14:33:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157188

FDA has placed a partial clinical hold on a BioNTech/Medilink Therapeutics Phase 1 clinical (NCT05653752) trial that is evaluating an 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-mutated non-small cell lung cancer or HR+/HER2-negative breast cancer. The partial hold pauses the enrollment of new patients in the trial in the U.S., according to the companies.

The agency communicated concerns with MediLink that BNT326/YL202 may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries, according to the companies. “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,” they say. MediLink says it has paused enrollment of new patients in the U.S. to address the FDA requirements.