Drug intelligence / Profile preview

H101 + tislelizumab + lenvatinib

Development stage
Unknown
Lead developer
Shanghai Sunway Biotech
Modality
Small Molecules, Oncolytic Viruses → Oncolytic Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intratumoral, Intravenous, Oral
01

Overview

This combination therapy is being investigated as a first-line treatment for advanced hepatocellular carcinoma (HCC). It consists of three distinct agents: **H101 (Oncorine)**, an oncolytic virus; **tislelizumab**, a monoclonal antibody; and **lenvatinib**, a small molecule kinase inhibitor. H101 is a recombinant human adenovirus type 5 engineered with a deletion of the E1B-55kDa gene, which allows it to selectively replicate in and destroy p53-deficient tumor cells while sparing normal tissue. Tislelizumab is a humanized IgG4 monoclonal antibody that targets the Programmed Cell Death Protein 1 (PD-1) receptor, blocking its interaction with PD-L1 and PD-L2 to enhance the anti-tumor immune response. Lenvatinib is a multi-targeted tyrosine kinase inhibitor that inhibits the vascular endothelial growth factor receptors (VEGFR1-3), fibroblast growth factor receptors (FGFR1-4), platelet-derived growth factor receptor alpha (PDGFRα), KIT, and RET. The combination aims to leverage direct viral oncolysis, immune checkpoint blockade, and anti-angiogenic activity to improve outcomes in advanced HCC. This specific regimen is currently being evaluated in a Phase 2 study sponsored by The First Affiliated Hospital of Bengbu Medical University.

Brand names
OncorineTevimbraLenvima
Other names
Recombinant Human Adenovirus Type 5 + tislelizumab + lenvatinib
02

Targets

FGFR4 (Fibroblast growth factor receptor 4)PDCD1 (Programmed cell death protein 1 receptor)PDGFRA (Platelet-derived growth factor receptor alpha)KIT (c-KIT proto-oncogene receptor tyrosine kinase)VEGFR2 (Vascular endothelial growth factor receptor 2)ITGAV (Integrin αV)FGFR3 (Fibroblast growth factor receptor 3)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR3 (Vascular endothelial growth factor receptor 3)CAR (Chimeric antigen receptor)FGFR2 (Keratinocyte growth factor receptor)FGFR1 (Fibroblast growth factor receptor 1)RET (Rearranged during transfection receptor tyrosine kinase)

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