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FDA lifts Partial Clinical Hold from Ph 1 trial of BNT326/YL202

“The complete response including data analysis, updated investigator brochure and informed consent for patients, and amended clinical trial protocol meets the FDA’s requirements by incorporating additional risk mitigation measures. BNT326/YL202 is a Human Epidermal Growth Factor Receptor 3 (“HER3”)-targeting antibody-drug conjugate (“ADC”) candidate that is being developed in collaboration between BioNTech SE (“BioNTech”) and MediLink. The trial recruitment will be re-initiated. Clinical development will focus on dose levels no higher than 3 mg/kg, where the safety profile was manageable and encouraging clinical activity was observed.”

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