Drug intelligence / Profile preview

sotigalimab + nivolumab + ipilimumab

Development stage
Phase 1
Lead developer
Pyxis Oncology
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

sotigalimab + nivolumab + ipilimumab is an investigational combination immunotherapy regimen being evaluated for the treatment of advanced solid tumors, specifically melanoma and renal cell carcinoma. The regimen consists of sotigalimab (APX005M), a humanized IgG1 monoclonal antibody that acts as an agonist for the CD40 receptor on antigen-presenting cells; nivolumab, a monoclonal antibody that inhibits the programmed death-1 (PD-1) receptor; and ipilimumab, a monoclonal antibody that targets the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). By combining a CD40 agonist with dual checkpoint inhibition, the therapy aims to simultaneously activate the innate immune system and remove inhibitory brakes on T-cell activity, potentially overcoming resistance to standard-of-care immunotherapies. Clinical development for this triplet is being conducted in collaboration with Yale University.

Other names
APX005M + nivolumab + ipilimumab
02

Targets

CD40 (Cluster of differentiation 40 receptor)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)PDCD1 (Programmed cell death protein 1 receptor)

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