AK104 + tinengotinib

AK104 + tinengotinib is a combination investigational regimen consisting of two distinct therapeutic agents: AK104, a bispecific monoclonal antibody targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4), and tinengotinib (TT-00420), a small-molecule multi-kinase inhibitor. AK104 functions as an immune checkpoint inhibitor by blocking both PD-1 and CTLA-4 pathways, thereby enhancing anti-tumor immune responses; tinengotinib inhibits several kinases including Aurora A and B, fibroblast growth factor receptors 1–3 (FGFR1/2/3), vascular endothelial growth factor receptors (VEGFRs), Janus kinase 1/2 (JAK1/2), and colony-stimulating factor 1 receptor (CSF1R), leading to antiproliferative, antiangiogenic, and immune modulatory effects. The combination is under investigation for advanced solid tumors, including triple-negative breast cancer, and has demonstrated activity in preliminary studies.