FDA Halts BioNTech-MediLink ADC Trial Due to ‘Significant Risk of Illness or Injuries’

1. Partial Clinical Hold: The FDA has placed a partial clinical hold on BioNTech and MediLink's Phase I study of an antibody-drug conjugate (ADC) candidate due to safety concerns.
2. Significant Risk: The FDA cited concerns that higher doses of BNT326 may expose patients to "unreasonable and significant risk of illness or injuries."
3. Patient Deaths: The trial has seen multiple patient deaths, with three fatalities reported.
4. Study Details: The study is testing the ADC as a later-line treatment option for patients with heavily pre-treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) or HR+/HER2-negative breast cancer.
5. Enrollment Pause: Enrollment of new patients in the U.S. has been paused while the companies review clinical and safety data, including observed grade 5 adverse events resulting in death.
6. Collaboration: BioNTech and MediLink are collaborating on the development of the ADC, with a deal worth potentially over $1 billion.
7. ADC Platform: The ADC candidate is based on MediLink's solid-tumor-focused TMALIN ADC platform, which BioNTech has also invested in for future applications.