Drug intelligence / Profile preview

LioCyx-M + lenvatinib

Development stage
Phase 2
Lead developer
Lion TCR
Modality
Cell Therapies, Gene Therapies, mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

**LioCyx-M + lenvatinib** is a combination therapy under clinical investigation for the treatment of hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). It consists of two components: - **LioCyx-M004** is an mRNA-encoded T-cell receptor (TCR)-T cell therapy product developed to target HBV-specific antigens. The therapy employs autologous T cells genetically engineered to express TCRs that recognize epitopes from the HBV virus, aiming to selectively eliminate HBV-infected hepatocytes and malignant liver cells presenting viral antigens. This approach seeks to restore anti-HBV immunity, which is functionally exhausted in these patients, enabling effective cytotoxic targeting of both cancerous and infected cells. - **Lenvatinib** is a small molecule, multi-kinase inhibitor approved as a first-line agent for advanced, unresectable HCC. Its mechanism includes inhibition of various receptor tyrosine kinases involved in tumor angiogenesis (VEGFR1, VEGFR2, VEGFR3), tumor proliferation (FGFR1-4), and the tumor microenvironment (PDGFRα, RET, KIT). The rationale for the combination is that lenvatinib modulates the tumor microenvironment to promote an immune-supportive profile, potentially enhancing T cell infiltration and efficacy. The combination is being evaluated in a multicenter Phase 2 clinical trial after FDA IND and Fast Track designation, targeting patients with HBV-related HCC refractory or relapsed to systemic therapies[1][3][4][5].

Other names
LioCyx-M004 + lenvatinib
02

Targets

FGFR1 (Fibroblast growth factor receptor 1)FGFR2 (Keratinocyte growth factor receptor)FGFR3 (Fibroblast growth factor receptor 3)FGFR4 (Fibroblast growth factor receptor 4)Hepatitis B virus peptide-human leukocyte antigen complexKIT (c-KIT proto-oncogene receptor tyrosine kinase)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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