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6MHP + NeoAg-mBRAF + polyICLC + CDX-1140

Development stage
Unknown
Lead developer
University of Virginia Health System
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Peptides, Vaccines & Immunotherapeutics
Administration
Subcutaneous, Intradermal
01

Overview

This refers to an investigational melanoma vaccine regimen being studied in a Phase I/II clinical trial (NCT04364230, also known as Mel66) led by Dr. Craig L. Slingluff, Jr. at the University of Virginia. The vaccine consists of a peptide mixture containing six melanoma helper peptides (6MHP) and a shared mutated BRAF-V600E neoantigen peptide (NeoAg-mBRAF or BRAF585-614-V600E), combined with two adjuvants: polyICLC (also known as Hiltonol, a TLR3 agonist) and CDX-1140 (an agonistic CD40 antibody developed by Celldex Therapeutics). The vaccine is a biologic/peptide-based immunotherapy designed to stimulate CD4+ T cell responses against melanoma. It targets MHC Class II-restricted melanoma antigens and is being evaluated for safety and immunogenicity in patients with high-risk melanoma, including cutaneous, mucosal, and uveal melanoma who have been rendered clinically free of disease after definitive treatment. The trial involves dose escalation of CDX-1140 while maintaining fixed doses of the peptides and polyICLC, with vaccines administered every 3 weeks for 4 doses.

Other names
Enhanced Melanoma Vaccine with CDX-11406MHP + NeoAg-mBRAF vaccine
02

Targets

MART-1/HLA-A*02:01 (Melanoma-associated antigen (Melanoma antigen recognized by T cells 1, Melanocyte protein PMEL, Tyrosinase) peptide-HLA-A*02:01 complex)CD40 (Cluster of differentiation 40 receptor)TLR3 (Toll-like receptor 3)Mutant BRAF neoantigen HLA–peptide complex

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