NEO-PV-01 + nivolumab + poly-ICLC

NEO-PV-01 + nivolumab + poly-ICLC is a combination investigational therapy comprising a personalized neoantigen peptide vaccine (NEO-PV-01), the PD-1 immune checkpoint inhibitor nivolumab, and the immunostimulatory adjuvant poly-ICLC. - **NEO-PV-01** is a personalized cancer vaccine designed from sequencing each patient's tumor to identify unique neoantigens, which are synthesized as peptides (typically up to 20 peptides) to stimulate a patient-specific T-cell-mediated immune response against cancer cells. - **Nivolumab** is a monoclonal antibody targeting the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2 to release the brakes on T cell immune activity against tumor cells. - **Poly-ICLC** (Hiltonol) is a synthetic double-stranded RNA acting as a toll-like receptor 3 (TLR3) agonist, serving as an immune adjuvant and enhancer of vaccine immunogenicity. This combination is under investigation for the treatment of advanced or metastatic melanoma, non-small cell lung cancer (NSCLC), and bladder cancer. Clinical trials have demonstrated immunogenicity and safety, and research is ongoing to evaluate clinical efficacy[1][4][5].