FDA stops inclusion of patients in cancer research trial led by Biontech's partner.
Last year in October, Biontech obtained the rights to a revolutionary cancer medication from Chinese MediLink Therapeutics in a potential deal worth over a billion dollars. However, MediLink, the Chinese partner, had to temporarily halt the Phase-1 trial of the drug due to safety concerns voiced by the US Food and Drug Administration (FDA), as stated in Biontech's press release.
The FDA had issues with the drug potentially causing severe diseases or injuries to the participants at higher doses. In response, MediLink stopped enrolling new patients in the study and assured compliance with the FDA's guidelines by providing pertinent pharmacological data.
This study, which is the initial phase of a three-phase clinical development, tested the drug in both the US and China for patients with advanced or metastatic lung or breast cancer who have undergone extensive prior treatment.
MediLink announced in October that Biontech had gained global rights to the drug, excluding mainland China, Hong Kong, and Macau. MediLink was to receive an initial payment of 70 million dollars, along with performance-based milestone payments that could reach one billion dollars.
This drug belongs to the category of Antibody-Drug Conjugates (ADCs), which target cancer cells and aim to eliminate them while minimizing harm to healthy tissue. These treatments are anticipated to be more tolerable than chemotherapy. Biontech's ADC program is just one of several.
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Because of the safety concerns raised by the FDA, the inclusion of new patients in Biontech's partner's cancer study was stopped. The FDA had voiced these concerns during the review of the drug's Phase-1 trial conducted by Biontech's partner. The FDA's actions led to a pause in patient admissions for the Cancer study conducted by Biontech's partner and themselves.
