{"id":398,"date":"2024-08-20T09:29:29","date_gmt":"2024-08-20T01:29:29","guid":{"rendered":"https:\/\/flcube.com\/?p=398"},"modified":"2024-10-13T18:44:02","modified_gmt":"2024-10-13T10:44:02","slug":"biontechs-bnt326-yl202-clears-fda-hurdle-advancing-in-clinical-trials-for-solid-tumor-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=398","title":{"rendered":"BioNTech’s BNT326\/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment"},"content":{"rendered":"\n

FRANKFURT\u2014BioNTech SE (NASDAQ: BNTX<\/a>), 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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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