California-based Arcus Biosciences (NYSE: RCUS) and Bristol Myers Squibb (BMS; NYSE: BMY) announced a clinical trial collaboration and supply agreement to evaluate casdatifan in combination with pumitamig in advanced renal cell carcinoma. Under the arrangement, Arcus will supply casdatifan for inclusion as two new arms within the BMS-sponsored Phase I/II ROSETTA RCC-208 trial, which evaluates pumitamig — the PD-L1/VEGF-A bispecific antibody jointly developed by BioNTech and BMS — alone or in combination across advanced RCC settings. Each company retains independent development and commercial rights to its respective asset, and the agreement is mutually non-exclusive.

Casdatifan is an oral, once-daily small-molecule inhibitor of hypoxia-inducible factor 2-alpha, a transcription factor dysregulated in the majority of clear cell RCC cases due to loss-of-function mutations in the VHL tumor suppressor gene. Pumitamig is a bispecific antibody (BsAb) from BioNTech and BMS that combines PD-L1 checkpoint blockade with VEGF-A neutralization, targeting two independently validated pathways in RCC. The ROSETTA RCC-208 trial will assess the combination regimen across Phase I/II dose-finding and expansion cohorts in advanced RCC, with casdatifan combinations added as two distinct arms to the existing trial structure.

Financial terms were not disclosed. Each company retains full development and commercial rights to its own asset; no royalties, milestones, or profit-sharing provisions apply under this supply arrangement. Arcus holds global rights to casdatifan outside Japan and select Asian territories, where Taiho Pharmaceutical holds an exclusive license exercised in October 2025.

Arcus previously included casdatifan in a collaboration with Gilead, but reclaimed rights after the latter declined to exercise an option to the molecule in February 2025. Arcus simultaneously raised USD 150 million to self-fund a Phase III program. BMS’s involvement follows the June 2025 announcement of its up-to-USD 11.1 billion global co-development and co-commercialization partnership with BioNTech for pumitamig across more than ten solid tumor indications, making the Arcus supply agreement a direct downstream extension of that foundational collaboration.

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