US pharma major Bristol-Myers Squibb Company, and UK-based F-star Alpha Ltd. announced that the companies, together with the F-star Alpha Ltd. shareholders, have entered into an agreement that provides Bristol-Myers Squibb the exclusive option to acquire F-star Alpha Ltd, and gain worldwide rights to its lead asset FS102. FS102 is a novel phase 1 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.
“This agreement is consistent with our R&D strategy to develop promising treatments that address areas of high unmet medical need, and provides the opportunity to complement our oncology portfolio with a novel targeted therapy,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. “We look forward to working with F-star and leveraging our broad clinical expertise in oncology to uncover the full potential of FS102.”
“We are thrilled that a company with the oncology experience and expertise of Bristol-Myers Squibb will be advancing our first clinical asset with the potential to provide a significant improvement over the current standard of care for a defined group of patients with HER2-positive cancer,” said John Haurum, chief executive officer at F-star Biotechnology Ltd. “In addition to the important improvement of cancer therapy FS102 may provide to patients, this programme also provides validation of the Modular Antibody Technology platform as a powerful engine to discover and rapidly develop novel targeted biologics.”
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 tumours. 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 tumour cells. In preclinical studies, FS102 has demonstrated encouraging efficacy against certain HER2-positive cancers and major regression in tumours, including those that are refractory to treatment with trastuzumab plus pertuzumab.
Under the terms of the agreement, Bristol-Myers Squibb will make payments aggregating to $50 million that consist of an option fee for the right to acquire F-star Alpha Ltd., payment for certain rights and licenses from F-star Alpha Ltd. and a clinical milestone payment upon initiation of the Phase 1 trial. Bristol-Myers Squibb will be responsible for conducting and funding development of FS102 during the option period. Bristol-Myers Squibb can exercise the option to acquire F-star Alpha Ltd. in its sole discretion upon its decision to commence a phase 2b 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 3 clinical trial and regulatory approvals in the US and Europe.
F-star GmbH and its wholly-owned subsidiary F-star Biotechnology Ltd. (F-star) is a biopharmaceutical company dedicated to developing novel bispecific antibody products that provide a significant improvement over the current standard of care. In 2013, F-star established an asset-centric vehicle structure through the formation of F-star Alpha Ltd., which included out-licencing of FS102 from F-star to F-star Alpha Ltd.
Given its strong patent position, F-star is the only biopharmaceutical company with the ability to create and develop Fcabs and bispecific antibodies by modifying the constant region of an antibody. In particular, F-star’s Modular Antibody Technology enables rapid discovery and development of bispecific antibodies by engineering additional binding sites into the constant region of an antibody. This technology offers unprecedented speed and ease in the development and manufacturing of genuine bispecific antibody products. Using the Modular Antibody Technology, F-star generates bispecific antibodies (mAb2) that possess the favourable characteristics of traditional monoclonal antibodies, without the production challenges often associated with other antibody formats. F-star is now applying its proprietary technology to the development of a pipeline of product candidates.