PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and

Mansi Saxena1,2, Thomas U Marron2, Julia Kodysh3

  • 1Vaccine and Cell Therapy Laboratory, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

Cancer Discovery
|March 17, 2025
PubMed
Abstract

Insights

The PGV001 platform is a safe and effective cancer vaccine. It successfully identified neoantigens, leading to new clinical trials for various cancers.

Area of Science:

  • Oncology
  • Immunotherapy
  • Bioinformatics

Background:

  • The development of personalized cancer vaccines is a rapidly evolving field.
  • Identifying and targeting neoantigens is crucial for effective cancer immunotherapy.

Purpose of the Study:

  • To evaluate the feasibility, safety, and immunogenicity of the PGV001 cancer vaccine platform.
  • To assess the utility of the OpenVax pipeline in predicting immunogenic neoantigens across diverse tumor types.

Main Methods:

  • The study involved the administration of the PGV001 vaccine.
  • The OpenVax bioinformatics pipeline was utilized to analyze tumor mutational data and predict neoantigens.
  • Immunogenicity was assessed through various immunological assays.

Main Results:

  • The PGV001 platform demonstrated feasibility, safety, and immunogenicity in the study population.
  • The OpenVax pipeline successfully predicted immunogenic neoantigens in tumors with a broad spectrum of mutational burdens.
  • The promising results from this study have led to the initiation of three new clinical trials.

Conclusions:

  • The PGV001 platform represents a feasible, safe, and immunogenic approach to cancer vaccination.
  • The OpenVax pipeline is a valuable tool for identifying neoantigens in diverse cancers.
  • This research supports the expansion of PGV001 into new clinical trials for glioblastoma, urothelial cancer, and prostate cancer.