Bristol-Myers Squibb Company and Five Prime Therapeutics, Inc., recently signed a new exclusive worldwide licensing and collaborative partnership revolving around the latter’s colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008, an agent currently in Phase I studies as an immuno-oncology candidate. The new agreement replaces the two parties’ previous collaborative partnership to evaluate the safety, tolerability and efficacy of Opdivo (nivolumab) when combined with Bristol-Myers Squibb’s programmed-death 1 (PD-1) immune checkpoint inhibitor, and FPA008 in six tumor types.
“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, MB BChir, 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, MD, PhD, 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. 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.”
According to the agreement’s terms, Five Prime will be entitled to an up-front payment of $350 million. Bristol-Myers Squibb will retain responsibility for developing and manufacturing FPA008 for the agreed upon range of indications, in support of Five Prime’s option to independently carry out studies geared toward bringing the agent closer to approval in Pigmented villonodular synovitis (PVNS), and in combination with its other pipeline immuno-oncology products.
Five Prime will proceed with and complete the ongoing Phase 1a/1b study on combined Opdivo and FPA008, which was originally launched under the two companies’ November 2014 agreement. Bristol-Myers Squibb will oversee global commercialization activities, while Five Prime retains rights to participate in commercial efforts in the United States.
Five Prime will also be eligible for development and regulatory milestone payments worth up to $1.05 billion for each anti-CSF1R product approved for cancer indications, and as much as $340 million per anti-CSF1R product approved for indications outside of cancer.