BMS, Five Prime In Immuno-oncology Alliance

Bristol-Myers Squibb Co.and Five Prime Therapeutics, Inc.have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of Five Prime’s colonystimulating factor 1 receptor (CSF1R) antibody program, including FPA008 which is in Phase I development for immunology and oncology indications. This agreement replaces the companies’ existing clinical collaboration to evaluate the safety, tolerability and efficacy of combining BMS’ Opdivo (nivolumab), a programmed-death 1 (PD-1) immune checkpoint inhibitor, with FPA008 in six tumor types.

BMS will make an upfront payment of $350 million and will be responsible for development and manufacturing of FPA008 for all indications, subject to Five Prime’s option to conduct certain future studies to support approval of FPA008 in PVNS and FPA008 in combination with its immuno-oncology pipeline assets. Five Prime will continue to conduct the current Phase 1a/1b trial evaluating the combination of Opdivo and FPA008 in six tumor settings.

BMS will be responsible for global commercialization, and Five Prime will retain rights to a U.S. co-promotion option. Five Prime will be eligible to receive as much as $1.05 billion in development and regulatory milestones per anti-CSF1R product for oncology indications (including combinations with Opdivo and any other agent), and as much as $340 million per anti-CSF1R product for non-oncology indications, as well as royalties.

“By blocking a key mediator of immunosuppression in the tumor microenvironment, CSF1R inhibition with FPA008 represents a potentially important complementary immuno-oncology mechanism of action to the T-cell directed antibodies and co-stimulatory molecules in our pipeline,” said Francis Cuss, MBBChir, FRCP, executive vice president and chief scientific officer of Bristol-Myers Squibb. “This agreement, which builds upon our existing relationship with Five Prime in immuno-oncology, is another important example of our commitment to expanding our presence in this space and to researching novel combination regimens.”

“We believe this transformational collaboration with Bristol-Myers Squibb for our CSF1R antibody program represents the best of both worlds in terms of maximizing the potential of FPA008,” said Lewis T. “Rusty” Williams, M.D., Ph.D., president and chief executive officer of Five Prime Therapeutics. “Bristol-Myers Squibb has undisputed leadership in the immuno-oncology landscape, deep clinical development and regulatory expertise, and an established commercial infrastructure to deliver important new therapies to patients.”