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This combination is an investigational immunotherapeutic regimen for cancer, composed of: - **NEO-PV-01**: a personalized peptide neoantigen vaccine made using patient-specific tumor neoantigen peptides, designed to elicit T-cell responses targeting the patient’s unique tumor mutations. - **poly-ICLC**: a synthetic double-stranded RNA (Polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose) that serves as an immune adjuvant, stimulating innate immunity primarily through TLR3 signaling. - **nivolumab**: a monoclonal antibody immune checkpoint inhibitor that targets PD-1 on T cells, blocking its interaction with PD-L1/PD-L2 to enhance anti-tumor T cell responses. - **APX005M**: a monoclonal antibody agonist of CD40, a receptor on antigen-presenting cells, boosting the activation of dendritic cells, B cells, and macrophages to enhance adaptive immunity. This combination aims to enhance personalized anti-tumor immune responses by vaccination, augment T-cell activity, promote antigen presentation and further stimulate innate and adaptive immune responses to cancer. It is under investigation mainly for advanced melanoma, with preclinical and early clinical trial evidence supporting safety and immunogenicity[3].
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