JHVEPhoto BioNTech ( NASDAQ: BNTX ) said the FDA has placed a partial clinical hold on a Phase 1 study for its oncology drug candidate BNT326/YL202 over safety concerns. The clinical trial is being sponsored by development partner Suzhou MediLink. The study is evaluating the antibody drug conjugate, or ADC, in the treatment of advanced or metastatic EGFR-mutated non-small cell lung cancer or HR+/HER2- breast cancer, according to a BioNTech filing .
BioNTech said the partial hold was placed over concerns about the safety of the drug at higher doses. Enrollment in the study will be paused while MediLink addresses the FDA’s concerns. MediLink and BioNTech entered into an agreement to development BNT326 in October.
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