Drug intelligence / Profile preview

LV305

Development stage
Phase 1
Lead developer
Merck
Modality
Dendritic Cell Vaccines → Immune Effector Cells → Other Cell Types → Cell Therapies, mRNA Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Lentiviral Vectors → Retroviral Vectors → Viral Vectors → Gene Addition/Replacement → Gene Therapies
Administration
Intradermal
01

Overview

LV305 is an engineered, integration-deficient, replication-incompetent lentiviral vector designed to target dendritic cells in vivo and deliver the gene encoding the full-length human tumor-associated antigen NY‑ESO‑1. By transducing dendritic cells at the injection site, LV305 induces expression of NY‑ESO‑1 within these antigen-presenting cells, stimulating a robust CD8+ T-cell immune response against tumors expressing this cancer-testis antigen. The therapy aims to generate long-lasting antitumor immunity with low inflammatory response and early induction of memory T-cells. Developed as a novel immunotherapy for patients with advanced or metastatic solid tumors positive for NY‑ESO‑1—including melanoma, sarcoma (including synovial sarcoma), ovarian cancer, and non-small cell lung cancer—LV305 has been evaluated as both a single agent and in combination regimens (notably as part of CMB305). Clinical trials have demonstrated favorable safety profiles and promising immunogenicity[5][6][7][8].

Brand names
DCVex NY-ESO-1DCVex/NY-ESO-1 cancer vaccine
Other names
ZVex-based NY-ESO-1 vaccine
02

Targets

CD209 (Dendritic cell-specific intercellular adhesion Molecule-3-Grabbing non-integrin)

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