Clinical Trial Uses Patient’s Own Tumor To Manufacture Anti-Cancer Vaccine Interview with:
Chrisann Kyi, MD
Fellow, Division of Hematology and Medical Oncology
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box 1079
New York, NY 10029 What is the background for this study? What are the main findings?

Response: Mutation-derived tumor antigens (MTAs or neoantigens) arise as a direct result of somatic mutations, including nucleotide substitutions, insertions, and deletions that occur during carcinogenesis. These somatic variations can be characterized via genetic sequencing and used to identify MTAs with predictive computational genomics and algorithms. To be a good candidate for a cancer vaccine, a mutated cancer protein must be visible and recognized by T cells, the soldiers of the immune system, so that they in turn can be educated to seek out and destroy cancer cells that bear the mutated protein.

At annual ASCO conference this year, we are presenting an exciting clinical trial investigating the feasibility, safety, and immunogenicity of a personalized MTA-based multi-peptide vaccine in the adjuvant treatment for multiple solid tumors.

In this trial, the patient’s own tumor is used to manufacture a cancer vaccine according to the mutations in their individual tumor. This vaccine is then given back to the patient in the adjuvant setting. The clinical trial is currently open and accruing at Tisch Cancer Center at Mount Sinai Hospital, NY What should readers take away from your report?

Response: Our clinical trial is exploring the safety and immunogenicity of PGV001 in patients with multiple solid tumor types. This clinical trial is a single-arm, open label, phase I study designed to test the safety and immunogenicity of the Personalized Genomic Vaccine 001 (PGV001) in multiple solid tumor types including head and neck, lung, breast, and ovarian cancers, among others. Eligible patients must have no measurable disease at time of first vaccine administration, and 5-year disease recurrence risk of > 30%. Patients will receive 10 doses of PGV001 as well as 10 doses of poly-ICLC (a toll-like receptor-3 agonist, vaccine adjuvant), administered 1 day after PGV001 vaccination. What recommendations do you have for future research as a result of this study?

Response: We encourage doctors, oncologists, and patients to refer any potential candidates for consideration in clinical trial enrollment. The cancer field is changing and progressing so rapidly that it’s difficult to keep up to date with the newest clinical trials! We want to spread word of this exciting trial in a forum that encourages collaboration and teamwork among physicians, health care professionals, scientists, and patients. Is there anything else you would like to add?

Response: We hope that the lessons learned from this clinical trial will instruct the next generation of MTA-based vaccines, future development of immunotherapeutic approaches and design of rational combinations. Personalized cancer vaccine therapies have the potential to revolutionize patient and clinical outcomes in cancer. Thank you for this opportunity to discuss our clinical research. Thank you for your contribution to the community.


ASCO 2017 abstract entitled “A Phase I Study of the Safety and Immunogenicity of a Multi-Peptide Personalized Genomic Vaccine in the Adjuvant Treatment of Solid Cancers

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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