PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting.
Quick Facts
What This Study Found
The PGV001 personalized neoantigen vaccine platform was feasible, safe, and triggered immune responses in patients with solid and blood cancers. It predicted immunogenic targets even in tumors with few mutations.
Key Numbers
Phase 1 study in solid and hematologic malignancies. OpenVax pipeline predicted neoantigens across wide-ranging mutational burdens. Three additional trials launched (glioblastoma, urothelial cancer + ICI, prostate cancer).
How They Did This
Phase 1, open-label study of the PGV001 personalized multi-peptide neoantigen vaccine in patients with solid and hematologic cancers in the adjuvant setting. Used OpenVax computational pipeline for neoantigen prediction.
Why This Research Matters
Personalized cancer vaccines are a frontier of immunotherapy. This Phase 1 trial shows the approach works safely across tumor types and has spawned three follow-up trials in glioblastoma, bladder cancer, and prostate cancer.
What This Study Doesn't Tell Us
Phase 1 (safety/feasibility focus). Small sample size typical of Phase 1. No efficacy endpoints. Adjuvant setting only.
Trust & Context
- Original Title:
- PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting.
- Published In:
- Cancer discovery, 15(5), 930-947 (2025)
- Authors:
- Saxena, Mansi, Marron, Thomas U, Kodysh, Julia, Finnigan, John P, Onkar, Sayali, Kaminska, Anna, Tuballes, Kevin, Guo, Ruiwei, Sabado, Rachel Lubong, Meseck, Marcia, O'Donnell, Timothy J, Sebra, Robert P, Parekh, Samir, Galsky, Matthew D, Blasquez, Ana, Gimenez, Gustavo, Bicak, Mesude, Cimen Bozkus, Cansu, Delbeau-Zagelbaum, Daniela, Rodriguez, Denise, Acuna-Villaorduna, Ana, Misiukiewicz, Krzysztof J, Posner, Marshall R, Miles, Brett A, Irie, Hanna Y, Tiersten, Amy, Doroshow, Deborah B, Wolf, Andrea, Mandeli, John, Brody, Rachel, Salazar, Andres M, Gnjatic, Sacha, Hammerbacher, Jeff, Schadt, Eric, Friedlander, Philip, Rubinsteyn, Alexander, Bhardwaj, Nina
- Database ID:
- RPEP-13443
Evidence Hierarchy
Read More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-13443APA
Saxena, Mansi; Marron, Thomas U; Kodysh, Julia; Finnigan, John P; Onkar, Sayali; Kaminska, Anna; Tuballes, Kevin; Guo, Ruiwei; Sabado, Rachel Lubong; Meseck, Marcia; O'Donnell, Timothy J; Sebra, Robert P; Parekh, Samir; Galsky, Matthew D; Blasquez, Ana; Gimenez, Gustavo; Bicak, Mesude; Cimen Bozkus, Cansu; Delbeau-Zagelbaum, Daniela; Rodriguez, Denise; Acuna-Villaorduna, Ana; Misiukiewicz, Krzysztof J; Posner, Marshall R; Miles, Brett A; Irie, Hanna Y; Tiersten, Amy; Doroshow, Deborah B; Wolf, Andrea; Mandeli, John; Brody, Rachel; Salazar, Andres M; Gnjatic, Sacha; Hammerbacher, Jeff; Schadt, Eric; Friedlander, Philip; Rubinsteyn, Alexander; Bhardwaj, Nina. (2025). PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting.. Cancer discovery, 15(5), 930-947. https://doi.org/10.1158/2159-8290.CD-24-0934
MLA
Saxena, Mansi, et al. "PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting.." Cancer discovery, 2025. https://doi.org/10.1158/2159-8290.CD-24-0934
RethinkPeptides
RethinkPeptides Research Database. "PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Plat..." RPEP-13443. Retrieved from https://rethinkpeptides.com/research/saxena-2025-pgv001-a-multipeptide-personalized
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.