Bristol-Myers Squibb (BMS) has signed an exclusive option for up to $475 million to acquire F-star Alpha and gain worldwide rights to its lead asset and first clinical compound FS102, the companies said today.
FS102 is a Phase I-ready breast and gastric cancer treatment that targets human epidermal growth factor Receptor 2 (HER2) in patients who do not respond to or resist current therapies.
FS102 is designed to work by binding to a unique site on HER2, then inducing programmed cell death in HER2-positive tumor cells. In preclinical studies, F-star has said, FS102 has demonstrated encouraging efficacy against certain HER2-positive cancers and major regression in tumors, including those refractory to treatment with trastuzumab plus pertuzumab.
BMS agreed to pay F-star a $50 million option fee for the right to acquire F-star Alpha, a payment for rights and licenses from F-star Alpha, and an unspecified clinical milestone payment upon initiation of the Phase I trial.
F-star Alpha is an entity created by F-star Biotechnology to own key assets of parent F-star. These assets include FS102 and other Fcabs or bispecific antibodies (mAb2™) against oncology and immuno-oncology targets, generated through the company’s Modular Antibody Technology platform. The platform is designed to enable rapid discovery and development of bispecific antibodies by engineering additional binding sites into the constant region of an antibody.
F-star Alpha was launched last year through a Series A investment of €9.4 million (nearly $12 million) from Atlas Venture, Aescap Venture, TVM Capital, SR One, MP Healthcare Venture Management, and MS Ventures.
John Haurum, M.D., F-star’s CEO, added that the deal validates the Modular Antibody Technology “as a powerful engine to discover and rapidly develop novel targeted biologics.”
BMS will oversee conducting and funding development of FS102 during the option period, and can exercise the option to acquire F-star Alpha in its sole discretion upon its decision to commence a Phase IIb trial. The company has also agreed to make payments tied to milestones that include the start of a Phase III clinical trial and regulatory approvals in the U.S. and Europe.
“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,” Francis Cuss, BMS’ evp and CSO, said in a statement.
BMS is one of three pharma giants with which F-star has collaborations in progress. F-star and Merck Serono in 2011 agreed to jointly discover new antibody-derived therapeutic products against up to three therapeutic targets, in a deal that could net F-star up to €492 million (about $627.3 million) and undisclosed tiered royalties on product sales.
A year earlier, F-star and Boehringer Ingelheim (BI) launched a partnership for joint discovery of new antibody-derived therapeutic products against up to seven separate therapeutic targets. F-star stands to gain up to €180 million ($229.5 million) in milestone payments from BI tied to “full commercial success” of multiple therapeutic products, plus royalties on net sales. In January, F-star said it received an undisclosed milestone payment from BI for successfully delivering Fcab antibody fragments against an undisclosed target.