Bristol-Myers Squibb (BMS) and Five Prime Therapeutics have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of the combination of Opdivo (nivolumab) and FPA008 in six tumour types.
Opdivo is BMS’s investigational programmed death-1 (PD-1) immune checkpoint inhibitor, while FPA008 is Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R).
As part of the deal, a Phase Ia/IIb trial will evaluate the combination of Opdivo and FPA008 as a potential treatment option for patients with non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.
BMS has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.
Both Opdivo and FPA008 are part of a new class of cancer treatments known as immunotherapies and they are designed to harness the body’s own immune system to fight cancer.
In Japan, Opdivo is approved to treat patients with unresectable melanoma and is being developed in multiple tumour types in more than 50 clinical trials.
Bristol-Myers Squibb senior vice-president and head of Development, Oncology Michael Giordano said: "This collaboration supports our strategy to expand the clinical development of Opdivo, including novel combination regimens and across numerous tumour types."
FPA008 is also being developed as a potential treatment for rheumatoid arthritis (RA) and solid tumours, has been dosed in a Phase I clinical trial in RA.
Preclinical data from this trial shows that combining antibodies targeting PD-1 and CSF1R may lead to an improved anti-tumour immune response compared to either approach alone in treating cancer.
As part of the deal, BMS will make a one-time payment of $30m to Five Prime and will be responsible for study costs, while the latter will be responsible for conducting the clinical trial scheduled to commence in 2015.