Drug intelligence / Profile preview

NEO-PV-01 + nivolumab

Development stage
Phase 1
Lead developer
BioNTech
Modality
Vaccines & Immunotherapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous (nivolumab), Subcutaneous Or Intramuscular For Vaccine Administration (typical For Peptide Vaccines)
01

Overview

NEO-PV-01 + nivolumab is a combination immunotherapy regimen consisting of a personalized neoantigen cancer vaccine (NEO-PV-01) combined with the immune checkpoint inhibitor nivolumab. NEO-PV-01 is a custom-designed vaccine tailored to each patient's tumor molecular profile, containing up to 20 peptides derived from tumor-specific neoantigens. These peptides are administered with an adjuvant (Poly-ICLC) to stimulate the immune system. Nivolumab is an anti-programmed cell death protein 1 (PD-1) monoclonal antibody that blocks PD-1, enhancing T-cell mediated anti-tumor immunity. The combination aims to induce de novo and expand existing T cell responses against tumor-specific neoantigens while simultaneously releasing PD-1 mediated inhibition of T cells, thereby improving anti-tumor efficacy beyond what nivolumab alone can achieve. This approach has been investigated primarily in advanced melanoma, non-small cell lung cancer, and bladder cancer patients.

Other names
Personalized neoantigen vaccine with nivolumab
02

Targets

pMHC (Peptide-MHC complex family)PDCD1 (Programmed cell death protein 1 receptor)

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