Incyte Corporation and Bristol-Myers Squibb have formed a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of a combination regimen of Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, nivolumab, and Incyte's oral, small-molecule indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, in a Phase I/II study. Multiple tumor types will be explored in the study, which could potentially include melanoma, non-small cell lung, ovarian, colorectal, squamous cell carcinoma of the head and neck, and diffuse large B-cell lymphoma.

Nivolumab and INCB24360 are part of a new class of cancer treatments known as immunotherapies. Nivolumab and INCB24360 target distinct regulatory components of the immune system, and there is preclinical evidence suggesting that the combination of these two agents may lead to an enhanced anti-tumor immune response compared to either agent alone. In 2013, the FDA granted Fast Track designation for nivolumab in these three tumor types.

The study, which is expected to begin in the fourth quarter of 2014, will be co-funded by the companies and conducted by Incyte. Additional details of the collaboration were not disclosed.

Earlier this month, Incyte had formed a clinical collaboration with Medimmune, the biologics arm of AstraZeneca. The Phase I/II oncology study will evaluate the efficacy and safety of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte's INCB24360.Both MEDI4736 and INCB24360 are immunotherapies.

Source: Bristol-Myers  Squibb

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