PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting

Mansi Saxena^#^{1

2}, Thomas U Marron^#², Julia Kodysh³, John P Finnigan Jr², Sayali Onkar¹, Anna Kaminska¹, Kevin Tuballes², Ruiwei Guo², Rachel Lubong Sabado¹, Marcia Meseck¹, Timothy J O'Donnell³, Robert P Sebra³, Samir Parekh², Matthew D Galsky², Ana Blasquez², Gustavo Gimenez², Mesude Bicak², Cansu Cimen Bozkus^{1

2}, Daniela Delbeau-Zagelbaum², Denise Rodriguez², Ana Acuna-Villaorduna², Krzysztof J Misiukiewicz², Marshall R Posner², Brett A Miles^{2

4}, Hanna Y Irie², Amy Tiersten², Deborah B Doroshow², Andrea Wolf², John Mandeli², Rachel Brody⁵, Andres M Salazar⁶, Sacha Gnjatic², Jeff Hammerbacher², Eric Schadt², Philip Friedlander², Alexander Rubinsteyn^{3

7}, Nina Bhardwaj^{1

2

8}

Affiliations

¹ Vaccine and Cell Therapy Laboratory, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
² Division of Hematology Oncology, Department of Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
³ Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, New York.
⁴ Department Otolaryngology Head and Neck Surgery, Northwell Cancer Institute, Northwell Health, New York, New York.
⁵ Department of Pathology, Icahn School of Medicine, New York, New York.
⁶ Oncovir, Inc., Winchester, Virginia.
⁷ Department of Genetics, University of North Carolina, Chapel Hill, North Carolina.
⁸ Parker Institute of Cancer Immunotherapy, San Francisco, California.

^# Contributed equally.

PMID: 40094414
DOI: 10.1158/2159-8290.CD-24-0934

Clinical Trial

PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting

Mansi Saxena et al. Cancer Discov. 2025.

. 2025 May 2;15(5):930-947.

doi: 10.1158/2159-8290.CD-24-0934.

Authors

Affiliations

¹ Vaccine and Cell Therapy Laboratory, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
² Division of Hematology Oncology, Department of Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
³ Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, New York.
⁴ Department Otolaryngology Head and Neck Surgery, Northwell Cancer Institute, Northwell Health, New York, New York.
⁵ Department of Pathology, Icahn School of Medicine, New York, New York.
⁶ Oncovir, Inc., Winchester, Virginia.
⁷ Department of Genetics, University of North Carolina, Chapel Hill, North Carolina.
⁸ Parker Institute of Cancer Immunotherapy, San Francisco, California.

^# Contributed equally.

PMID: 40094414
DOI: 10.1158/2159-8290.CD-24-0934

Abstract

The PGV001 platform is feasible, safe, and immunogenic. The OpenVax pipeline predicted immunogenic neoantigens in tumors with wide-ranging mutational burdens. Data from this study prompted three additional PGV001 trials, one in newly diagnosed glioblastoma, one in urothelial cancer in combination with an ICI, and another in prostate cancer.

PubMed Disclaimer

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting

Affiliations

PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting

Authors

Affiliations

Abstract

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical