FDA Partially Halts BioNTech-MediLink ADC Over 'Significant Illness Risk'

The FDA has imposed a partial clinical hold on a Phase I trial of an antibody-drug conjugate (ADC) developed by BioNTech and MediLink, intended for the treatment of certain types of non-small cell lung cancer (NSCLC) and breast cancer. This action follows the occurrence of several patient deaths during the study. BioNTech disclosed the hold in a recent SEC filing.

The ADC under investigation is aimed at patients with advanced or metastatic EGFR-mutated NSCLC or HR+/HER2-negative breast cancer who have already undergone extensive prior treatments. The FDA's partial hold specifically restricts the enrollment of new patients in the U.S. BioNTech noted that MediLink, the sponsor of the open-label trial, has been informed by the FDA that higher dosages of the ADC candidate, BNT326, might pose "unreasonable and significant risk of illness or injuries." Consequently, MediLink has temporarily halted patient enrollment to scrutinize clinical and safety data, including the grade 5 adverse events that have led to fatalities.

Details of the trial were outlined at the 2024 American Society of Clinical Oncology annual meeting, revealing that the ADC candidate demonstrated "adequate safety and tolerability." ADCs are designed to target cancer cells more accurately than traditional chemotherapy, thereby reducing harm to healthy cells.

In the dose-escalation study involving 52 participants, BioNTech reported a grade 3 dose-limiting toxicity event, specifically febrile neutropenia, at the highest dosing level. Other treatment-related adverse events included anemia, nausea, fatigue, and reductions in white blood cell, neutrophil, lymphocyte, and platelet counts.

Among the 46 patients who were evaluable, the companies observed one complete response, 16 partial responses, and 26 cases of stable disease. The ADC candidate is part of a collaborative research project between BioNTech and MediLink, announced in October 2023, which could potentially be worth over $1 billion. This collaboration highlights BioNTech's strategy to diversify its cancer treatment portfolio, especially as the demand for its COVID-19 vaccine diminishes.

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