Drug intelligence / Profile preview

Nofazinlimab + lenvatinib

Development stage
Phase 3
Lead developer
CStone Pharmaceuticals
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
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Overview

Nofazinlimab + lenvatinib is a combination therapy under investigation for the first-line treatment of advanced or unresectable hepatocellular carcinoma (HCC). Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody that targets programmed cell death protein 1 (PD-1), blocking its interaction with PD-L1 and PD-L2, thereby enhancing T-cell mediated anti-tumor immune responses. Lenvatinib is an oral multikinase inhibitor that blocks the kinase activities of vascular endothelial growth factor receptor 1 (VEGFR1), vascular endothelial growth factor receptor 2 (VEGFR2), vascular endothelial growth factor receptor 3 (VEGFR3), fibroblast growth factor receptor 1 (FGFR1–4), platelet-derived growth factor receptor alpha (PDGFRα), KIT, and RET. This dual approach aims to inhibit tumor angiogenesis and proliferation while simultaneously promoting immune-mediated tumor cell killing. The combination has shown promising efficacy and manageable safety in phase 1b/3 trials for advanced HCC. Nofazinlimab was developed by CStone Pharmaceuticals; lenvatinib was developed by Eisai.

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Targets

FGFR1 (Fibroblast growth factor receptor 1)FGFR2 (Keratinocyte growth factor receptor)FGFR3 (Fibroblast growth factor receptor 3)FGFR4 (Fibroblast growth factor receptor 4)KIT (c-KIT proto-oncogene receptor tyrosine kinase)PDCD1 (Programmed cell death protein 1 receptor)PDGFRA (Platelet-derived growth factor receptor alpha)RET (Rearranged during transfection receptor tyrosine kinase)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR2 (Vascular endothelial growth factor receptor 2)VEGFR4 (Vascular endothelial growth factor Receptor-3)

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