FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase I clinical trial for BNT326/YL202, an anti-HER3 targeted antibody drug conjugate (ADC). This development paves the way for the resumption of trials focusing on the treatment of solid tumors.
BNT326/YL202, licensed from China’s MediLink Therapeutics (Suzhou) Co., Ltd, is a promising candidate in the field of oncology. The FDA’s decision comes after a review of safety concerns that had previously led to a partial clinical hold in June this year. The hold was initiated following patient deaths reported in two studies; however, these were attributed to high dosages of the drug.
Under the terms of the agreement with MediLink, BioNTech will now reinitiate trial recruitment, focusing on dosages not exceeding 3 mg/kg. This partnership, which has seen two deals struck between the companies, highlights BioNTech’s commitment to expanding its pipeline with innovative ADC candidates.
The first global approval for BNT326/YL202 was secured in the US in May 2023 for the treatment of patients with heavily pretreated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) or HR+/HER2-negative breast cancer. A conditional approval for the same patient population was granted by the FDA in February this year, marking a significant milestone for the molecule known as “Epkinly” in the US market.
With Edwards Lifesciences, accounting for 70% of the global valve market, having previously invested USD 180 million in BioNTech for product and market development, the future of BNT326/YL202 looks promising. The clinical trials’ resumption is expected to provide valuable data that could potentially change the treatment landscape for patients with certain types of cancer.- Flcube.com
