Bristol-Myers Squibb has paid £350m upfront to Five Prime Therapeutics to gain rights to a development programme that complements its cancer immunotherapy pipeline.
The deal gives BMS rights to Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody programme, currently headed by FPA008 which is in early-stage clinical testing.
BMS and Five Prime have been working together on a clinical trial combining FPA008 alongside Opdivo (nivolumab), BMS’ PD-1 inhibitor for melanoma and lung cancer.
The agreement – which includes $1.1bn in potential milestone payments in oncology and another $340m per product for milestones outside the cancer arena – is yet another indicator of the massive potential the industry sees in a new generation of drugs that harness the power of the immune system, particularly when used in combination.
BMS and its rivals in the field – such as Merck & Co, Roche, AstraZeneca and Merck KGaA/Pfizer – have spent billions of dollars forging alliances with other drug developers that have immuno-oncology candidates over the last couple of years.
In the latest deal Five Prime also stands to receive double-digit royalties on future sales and has an option to co-promote FPA008 in the US.
According to the company, preclinical data suggest that combining antibodies targeting PD-1 and CSF1R may lead to “an enhanced anti-tumour immune response compared to either drug alone”.
Like PD-1, CSF1R is involved in a pathway that leads to suppression of the immune system and switching it off is thought to help cancer patients’ own immune responses destroy malignant cells.
Specifically, the drug reduces the activation and survival of immunosuppressive tumour-associated macrophages (TAMs), by blocking the interaction of interleukin-34 (IL-34) with the receptor.
BMS and Five Prime will initially test the Opdivo/FPA008 combination in six tumour types, namely non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.
By late 2015 or early 2016, Five Prime expects to complete the phase Ia dose escalation portion of the study and commence phase Ib, which should provide some indicators of safety and efficacy.
Five Prime chief executive Rusty Williams noted however that its CSF1R-targeting drugs “may have therapeutic synergy” with a number of immuno-oncology candidates in BMS’ pipeline.
Meanwhile Five Prime is also conducting a phase I/II trial of FPA008 in pigmented villonodular synovitis (PVNS) – a rare and aggressive cancer affecting the joints – as well as a phase I trial in rheumatoid arthritis.
The company also has its own portfolio of immuno-oncology compounds outside the CSF1R programme, including a GITR agonist antibody and a CAR-T cell therapy partnered with Bluebird Bio.