BMS, Five Prime Enter Combo Therapy Clinical Pact

Bristol-Myers Squibb and Five Prime Therapeutics have entered an exclusive clinical collaboration to evaluate the safety and efficacy of BMS’ investigational immune checkpoint inhibitor Opdivo (nivolumab) with FPA008, Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R). The Phase Ia/Ib study will evaluate the combination as a potential treatment for patients with non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. If approved, Opdivo will serve as the trademark for nivolumab.
 
Opdivo and FPA008 are immunotherapies designed to harness the body’s own immune system to fight cancer. Opdivo is approved in Japan for the treatment of unresectable melanoma, and is being developed in multiple tumor types. FPA008 is in development as a potential treatment for rheumatoid arthritis (RA) and preclinical data suggest that combining antibodies targeting PD-1 and CSF1R may lead to an enhanced anti-tumor immune response compared to either therapy alone.
 
BMS will make a one-time payment of $30 million and will be responsible for study costs and Five Prime will conduct the trial. The agreement provides for exclusivity with respect to the development, with a collaborative partner, of combination regimens of anti-PD-1/PDL1 antagonists with an anti-CSF1R antagonist. BMS will have a limited right of first refusal if Five Prime wishes to seek a partner for FPA008.
 
“This collaboration supports our strategy to expand the clinical development of Opdivo, including novel combination regimens and across numerous tumor types,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “We are excited to build upon our existing relationship with Five Prime Therapeutics in immunooncology, and explore the full potential of Opdivo and FPA008 in multiple tumor types.”
 
“We are pleased to establish a second collaboration with Bristol-Myers Squibb in the area of immune-oncology,” said Lewis T. “Rusty” Williams, M.D., Ph.D., president and chief executive officer of Five Prime. “Their vision aligns with our commitment to advancing promising immune-modulating targets, alone or in combination, to create next-generation immunotherapies for cancer patients. We look forward to initiating this study and expanding the development of FPA008 as a potential immunotherapy for these six types of cancer.”