Drug intelligence / Profile preview

EVX-02 + nivolumab

Development stage
Discontinued
Lead developer
Evaxion
Modality
Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intramuscular (EVX-02), Intravenous (nivolumab)
01

Overview

EVX-02 + nivolumab is a **combination therapy** of a personalized DNA-based neoantigen cancer vaccine (EVX-02) and a checkpoint inhibitor (nivolumab) for cancer immunotherapy, specifically being investigated in resected malignant melanoma. EVX-02 is developed for each patient individually using Evaxion's AI platform (PIONEER) to identify relevant neoantigens from the patient’s tumor—these are encoded in a plasmid administered as the vaccine. Nivolumab, a monoclonal antibody against PD-1, is used to block immune checkpoint pathways and enhance T-cell–mediated antitumor responses. The combination induces robust, specific CD4+ and CD8+ T-cell activation against tumor neoantigens. Both components are aimed at improving immune recognition and killing of cancer cells. Clinical data from a Phase I/IIa trial indicated promising safety, tolerability, and immunogenicity, with all treated patients relapse-free within the study period[1][2][3][4].

Brand names
nivolumab (Opdivo)
Other names
EVX-02 + nivolumabEVX-02 and nivolumabEVX02 and nivolumabEVX 02 and nivolumab
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)Neoantigen (Patient-specific neoantigen epitope)pMHC-I (Peptide–MHC class I complex)

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