NEW YORK & SOUTH SAN FRANCISCO, Calif.—In a deal that expands on their existing relationship, Bristol-Myers Squibb Co. and Five Prime Therapeutics Inc. have struck an exclusive worldwide license and collaboration agreement to develop and commercialize Five Prime's colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008, currently in Phase 1 development for immunology and oncology indications. This deal takes the place of an existing clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Bristol-Myers Squibb's Opdivo (nivolumab), a programmed-death (PD-1) immune checkpoint inhibitor, with FPA008 in six tumor types.
“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,” Dr. Lewis T. “Rusty” Williams, president and CEO of Five Prime Therapeutics, remarked in a press release. “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. Bristol-Myers Squibb also has a rich pipeline of clinical candidates and approved products, a number of which may have therapeutic synergy when coupled with FPA008, given the potential of CSF1R inhibition to suppress the activity and survival of tumor associated macrophages. At the same time, Five Prime will continue to conduct trials in pigmented villonodular synovitis (PVNS) and immuno-oncology with FPA008, which is a product of our proprietary protein platform and our discovery of IL-34, one of the two ligands for CSF1R that FPA008 blocks.”
Per the terms of the agreement, Bristol-Myers Squibb will pay Five Prime $350 million up front, with the potential for up to $1.05 billion in development and regulatory milestone payments per anti-CSF1R product for oncology indications, and up to $340 million in development and regulatory payments per anti-CSF1R product for non-oncology indications. Five Prime also stands to receive double-digit royalties, which could be enhanced in the United States should Five Prime choose to exercise its co-promotion option.
Bristol-Myers Squibb will be responsible for developing and manufacturing FPA008 for all indications, subject to Five Prime's option to conduct certain future studies at its own cost, including registration studies to support approval of FPA008 in PVNS and in combination with Five Prime's internal immuno-oncology pipeline assets. Five Prime will continue conducting the ongoing Phase 1a/1b trial evaluating Opdivo together with FPA008 in six tumor settings through to completion, which is part of Five Prime and Bristol-Myers Squibb's initial clinical collaboration announced in November 2014. Bristol-Myers Squibb will be responsible for global commercialization, with Five Prime retaining rights to a co-promotion option in the United States.
“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,” Francis Cuss, executive vice president and chief scientific officer of Bristol-Myers Squibb, noted in a statement about the deal. “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.”
SOURCE: Bristol-Myers Squibb press release