The FDA has lifted the partial clinical hold on BioNTech and MediLink Therapeutics’ phase 1 trial of BNT326/YL202, the companies announced this week.
BNT326/YL202 is a HER3-targeting ADC codeveloped by the two companies. The hold was lifted after MediLink submitted a complete response, including data analysis, an updated investigator brochure, informed consent for patients, and an amended clinical trial protocol. The submissions addressed the FDA's requirements by incorporating additional risk mitigation measures.
With the hold lifted, trial recruitment will resume, focusing on dose levels no higher than 3 mg/kg, where the safety profile was manageable and clinical activity was promising.
The FDA has placed a partial hold on the phase 1 trial back in June, following BioNTech’s presentation of data at ASCO 2024, which showed that three patients had died in two dose cohorts.
MediLink and BioNTech began collaborating in October 2023 to develop an ADC targeting HER3, a receptor associated with tumor metastasis and disease progression in cancers like non-small cell lung cancer and breast cancer. Under the agreement, MediLink granted BioNTech exclusive global rights for development, manufacturing, and commercialization, excluding Mainland China, Hong Kong, and Macau. BioNTech made an upfront payment of $70 million to MediLink, with potential milestone payments exceeding $1 billion.