Bristol-Myers Squibb has entered into an agreement for the exclusive option to acquire F-star Alpha, an Austria-based biopharmaceutical company dedicated to developing novel bispecific antibody products, and gain worldwide rights to its lead asset FS102.

FS102 is a novel phase I-ready human epidermal growth factor receptor 2 (HER2)-targeted therapy in development for the treatment of breast and gastric cancer among a well-defined population of HER2-positive patients who do not respond or become resistant to current therapies.

HER2 is a highly validated target in breast and gastric cancers and plays a significant role in the growth of tumors and subsequent poor clinical outcome for patients with breast cancer and other solid tumors. Therapies that target HER2 have shown success in improving patient outcomes; however, a high proportion of HER2-positive patients do not respond to currently available treatments, and those who do may eventually develop resistance. 

FS102 is a HER2 targeted Fcab that has the potential to eliminate cancer cells through a novel mechanism of action in a biomarker-defined patient population. FS102 works differently than current HER2-targeted therapies, with the potential to overcome resistance that has developed against other HER2-targeted drugs. It binds to a unique site on HER2 and then induces programmed cell death in HER2-positive tumor cells. In preclinical studies, FS102 has demonstrated encouraging efficacy against certain HER2-positive cancers and major regression in tumors, including those that are refractory to treatment with trastuzumab plus pertuzumab. 

BMS will make payments aggregating to $50 million that consist of an option fee for the right to acquire F-star Alpha, payment for certain rights and licenses from F-star Alpha and a clinical milestone payment upon initiation of the phase I trial. BMS will be responsible for conducting and funding development of FS102 during the option period. BMS can exercise the option to acquire F-star Alpha in its sole discretion upon its decision to commence a phase IIb trial. Total aggregate consideration may reach $475 million, which includes the payments aggregating to $50 million, the option exercise fee and milestone payments upon the commencement of a phase III clinical trial and regulatory approvals in the U.S. and Europe.