PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Published version of a preprint
Abstract
Significance 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.
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PGV001 showed evidence of robust immune activation in patients with high-risk melanoma and multiple myeloma.
“For example, a single-arm, open-label, proof-of-concept Phase I study of PGV001 (NCT02721043ii), a multipeptide personalized neoantigen vaccine platform, demonstrated the safety of computationally guided neoantigen selection and vaccine formulation, with evidence of robust immune activation in patients with high-risk melanoma and multiple myeloma [130]”
From Phage therapy in oncology: opportunities for cancer prevention and treatment (2026) · cites this paper as [130]
Phage-based cancer vaccines and related viral/phage-derived platforms have progressed from preclinical proof-of-concept studies into a limited number of Phase I/II clinical trials.
“To date, phage-based cancer vaccines and related viral/phage-derived platforms have progressed from preclinical proof-of-concept studies into a limited number of Phase I/II clinical trials, primarily designed to evaluate safety, feasibility, and preliminary immunogenicity in both solid and hematological malignancies.”
From Phage therapy in oncology: opportunities for cancer prevention and treatment (2026) · cites this paper as [130]
A single-arm, open-label, proof-of-concept Phase I study of PGV001 (NCT02721043) demonstrated the safety of computationally guided neoantigen selection and vaccine formulation.
“For example, a single-arm, open-label, proof-of-concept Phase I study of PGV001 (NCT02721043ii), a multipeptide personalized neoantigen vaccine platform, demonstrated the safety of computationally guided neoantigen selection and vaccine formulation, with evidence of robust immune activation in patients with high-risk melanoma and multiple myeloma [130]”
From Phage therapy in oncology: opportunities for cancer prevention and treatment (2026) · cites this paper as [130]
These Phase I/II trials are primarily designed to evaluate safety, feasibility, and preliminary immunogenicity in both solid and hematological malignancies.
“To date, phage-based cancer vaccines and related viral/phage-derived platforms have progressed from preclinical proof-of-concept studies into a limited number of Phase I/II clinical trials, primarily designed to evaluate safety, feasibility, and preliminary immunogenicity in both solid and hematological malignancies.”
From Phage therapy in oncology: opportunities for cancer prevention and treatment (2026) · cites this paper as [130]
Cites
Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer
Sahin, U., Derhovanessian, E., Miller, M., Kloke, B.-P., Simon, P., Löwer, M., Bukur, V., Tadmor, A. D., Luxemburger, U., Schrörs, B., et al. (2017) · Nature · doi:10.1038/nature23003 · Cited by 2,488 · see citing works
Genomic correlates of response to immune checkpoint therapies in clear cell renal cell carcinoma
Miao, D., Margolis, C. A., Gao, W., Voss, M. H., Li, W., Martini, D. J., Norton, C., Bossé, D., Wankowicz, S. M., Cullen, D., et al. (2018) · Science · doi:10.1126/science.aan5951 · Cited by 1,249 · see citing works
Ott, P. A., Hu-Lieskovan, S., Chmielowski, B., Govindan, R., Naing, A., Bhardwaj, N., Margolin, K., Awad, M. M., Hellmann, M. D., Lin, J. J., et al. (2020) · Cell · doi:10.1016/j.cell.2020.08.053 · Cited by 738 · see citing works
Gainor, J. F., Patel, M. R., Weber, J. S., Gutierrez, M., Bauman, J. E., Clarke, J. M., Julian, R., Scott, A. J., Geiger, J. L., Kirtane, K., et al. (2024) · Cancer Discovery · doi:10.1158/2159-8290.cd-24-0158 · Cited by 124 · see citing works
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Phage therapy in oncology: opportunities for cancer prevention and treatment
Mutalik, V. K., Inman, J. L., Chang, H., Arkin, A., & Mao, J.-H. (2026) · Trends in Molecular Medicine · doi:10.1016/j.molmed.2026.02.001 · Cited by 5 · see citing works
- Authors
- Saxena, M., Marron, T. U., Kodysh, J., Finnigan, J. P., Onkar, S., Kaminska, A., Tuballes, K., Guo, R., Sabado, R. L., Meseck, M., O’Donnell, T. J., Sebra, R. P., Parekh, S., Galsky, M. D., Blasquez, A., Gimenez, G., Bicak, M., Cimen Bozkus, C., Delbeau-Zagelbaum, D., Rodriguez, D., Acuna-Villaorduna, A., Misiukiewicz, K. J., Posner, M. R., Miles, B. A., Irie, H. Y., Tiersten, A., Doroshow, D. B., Wolf, A., Mandeli, J., Brody, R., Salazar, A. M., Gnjatic, S., Hammerbacher, J., Schadt, E., Friedlander, P., Rubinsteyn, A., & Bhardwaj, N.
- Affiliations
- Tisch Cancer Institute (US)
- Icahn School of Medicine at Mount Sinai (US)
- Genentech (US)
- 2Division of Hematology Oncology, Department of Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
- 1Vaccine and Cell Therapy Laboratory, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
- Mount Sinai Hospital (US)
- Tampa General Hospital (US)
- Northwell Health (US)
- 6Oncovir, Inc., Winchester, Virginia.
- 3Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, New York.
- Parker Institute for Cancer Immunotherapy (US)
- Corresponding author
- Bhardwaj, Nina
- ORCID
- 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
- Venue
- Cancer Discovery
- Published
- 2025-03-17
- Volume
- 15
- Issue
- 5
- Pages
- 930-947
- ISSN
- 2159-8274 (ISSN-L)
- 2159-8290
- OpenAlex
- W4408505242
- Cited by
- 28
- References
- 4
- Citations by year
- 2026: 19 · 2025: 9
- FWCI
- 10.39
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Cancer Discovery (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Lake Champlain Cancer Research Organization (CRI-CLIP)
- Parker Institute for Cancer Immunotherapy
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › vaccines and immunoinformatics approaches
- Keywords
- personalized neoantigen vaccine, multipeptide vaccine, adjuvant immunotherapy, solid tumors, hematologic malignancies, T cell response, B cell response, immune checkpoint inhibitors, tumor mutational burden
- MeSH terms
- Antigens, Neoplasm, Feasibility Studies, Female, Humans, Male, Neoplasms, Hematologic Neoplasms, Cancer Vaccines, Precision Medicine
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