Bristol-Myers Squibb inks option agreement with F-Star Alpha

NEW YORK & CAMBRIDGE, United Kingdom—Bristol-Myers Squibb Co. and F-star Alpha Ltd., a biopharmaceutical company focused on the development of novel bispecific antibody products, have established an agreement that gives Bristol-Myers Squibb an exclusive option to acquire F-Star Alpha and gain worldwide rights to FS102, its lead drug candidate.

Per the terms of the agreement, Bristol-Myers Squibb will pay an aggregate of $50 million, which includes an option fee for the acquisition right, payment for certain rights and licenses from F-star Alpha Ltd. and a clinical milestone payment upon initiation of a Phase 1 trial for FS102. During the option period, Bristol-Myers Squibb will be responsible for conducting and funding development of the compound. The company can exercise its acquisition option in its sole discretion should it decide to initiate a Phase 2b trial. Total consideration for the deal could reach $475 million, which includes the payments totaling $50 million, the option exercise fee and milestone payments upon beginning a Phase 3 clinical trial and regulatory approvals in the United States and Europe.

“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,” commented John Haurum, M.D., D.Phil., CEO at F-star Biotechnology Ltd., a wholly owned subsidiary of F-star GmbH. “In addition to the important improvement of cancer therapy FS102 may provide to patients, this program also provides validation of the Modular Antibody Technology platform as a powerful engine to discover and rapidly develop novel targeted biologics.”

FS102 is a novel, Phase 1-ready Human Epidermal growth factor Receptor 2 (HER2)-targeted therapy being developed for the treatment of breast and gastric cancer within a population of HER2-positive patients who either do not respond or develop resistance to existing therapies. While HER2 is a highly validated target in these types of cancers, and treatments targeting HER2 are often successful in patients, a high number of HER2-positive patients do not respond to such treatments, and some who do can develop eventual resistance.

FS102 can potentially eliminate cancer cells by binding to a unique site on HER2 then inducing programmed cell death in HER2-positive tumor cells. Preclinical studies have shown FS102 to be efficacious against certain HER2-positive cancers and demonstrate significant regression in tumors, including those that are refractory to treatment with trastuzumab plus pertuzumab, a current therapeutic option. Due to its novel mechanism of action, FS102 has the potential to bypass the issue of resistance developed against other drugs targeting HER2.

“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 at 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.”

SOURCE: Bristol-Myers Squibb press release