The FDA has allowed BioNTech and Medilink to resume their Phase I oncology trial of BNT326/YL202, a HER3-targeting antibody-drug conjugate, but at a reduced dose due to safety concerns

The trial was previously halted due to adverse events such as decreased neutrophil counts and increased mucositis rates, which raised the risk of serious infections

Despite some concerns, the drug showed promising results at the ASCO 2024 Annual Meeting, although there were three reported deaths in the trial

With the clinical hold lifted, the trial will now proceed with a 3mg dose, and any patients currently on higher doses will be adjusted to this lower amount

BioNTech’s stock saw a notable increase following the announcement, and the company recently invested $70 million in a deal with MediLink for the drug’s development, with MediLink retaining rights in China and BioNTech holding the rights elsewhere