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casdatifan + tivunatamig

Development stage: Unknown
Lead developer: Arcus Biosciences
Modality: Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration: Intravenous, Oral

Overview

Casdatifan + tivunatamig is an investigational combination therapy being evaluated for the treatment of advanced or metastatic clear cell renal cell carcinoma (ccRCC). The combination pairs casdatifan (AB521), an orally bioavailable small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2α) developed by Arcus Biosciences, with tivunatamig (PF-08634404 / SSGJ-707), a bispecific monoclonal antibody targeting programmed cell death protein 1 (PD-1) and vascular endothelial growth factor A (VEGF-A) developed by 3SBio and licensed to Pfizer. By simultaneously inhibiting HIF-2α, the PD-1 immune checkpoint axis, and VEGF-mediated angiogenesis, this combination aims to provide a synergistic, tyrosine kinase inhibitor (TKI)-sparing therapeutic approach. It is currently being evaluated in the Pfizer-sponsored Phase 1b/2 Symbiotic-GU-08 platform study in patients with first-line advanced renal cell carcinoma.

Other names: AB-521 + PF-08634404AB-521 + PF-4404AB-521 + SSGJ-707AB-521 + tivunatamigAB521 + PF-08634404AB521 + PF-4404AB521 + SSGJ-707AB521 + tivunatamigcasdatifan + PF-08634404casdatifan + PF-4404casdatifan + SSGJ-707casdatifan plus tivunatamig

Targets

EPAS1 (Hypoxia-inducible factor 2-alpha)PDCD1 (Programmed cell death protein 1 receptor)VEGFA (Vascular endothelial growth factor A)

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