This record provides bibliographic details and links to the original research. An editorial study breakdown is not available.
What the researchers 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.
Why it 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.
The numbers in context
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 the study worked
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.
Who was studied
Patients with solid and hematologic malignancies in the adjuvant setting
What this study cannot tell us
Phase 1 (safety/feasibility focus). Small sample size typical of Phase 1. No efficacy endpoints. Adjuvant setting only.
Read the original research
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
Citation
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