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PGV-001 is a synthetic, peptide-based, personalized cancer vaccine platform designed to stimulate the immune system to recognize and attack cancer cells by targeting patient-specific tumor neoantigens. These neoantigens are unique mutations found in an individual’s tumor but not in normal tissue. The process involves sequencing both tumor and germline DNA/RNA from each patient, computationally identifying immunogenic mutant peptides (neoantigens) using the OpenVax pipeline, and synthesizing up to 10 selected peptides per patient. The resulting multi-peptide vaccine is administered with poly-ICLC as an adjuvant to enhance immune activation. Early clinical studies have shown that PGV-001 induces robust CD4+ and CD8+ T cell responses against these neoantigens with minimal toxicity (mostly mild injection site reactions). It has been tested in patients with various cancers at high risk of recurrence after standard therapy—including non-small cell lung cancer, head and neck cancer, urothelial carcinoma, breast cancer, multiple myeloma—and is being further studied in glioblastoma and prostate cancer[1][3][4][5][6][7][8].
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