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ISA-HPV is a therapeutic cancer vaccine composed of multiple synthetic long peptides derived from the E6 and E7 oncoproteins of human papillomavirus type 16, designed to elicit robust HPV16-specific CD4+ and CD8+ T‑cell responses that target and eradicate HPV16‑transformed cells in premalignant and malignant lesions.[1][6][9][13] Developed by ISA Pharmaceuticals, it is being investigated primarily for HPV16‑positive cancers such as cervical cancer, oropharyngeal and other head and neck squamous cell carcinomas, vulvar intraepithelial neoplasia, and other HPV16‑positive solid tumors, both as monotherapy and in combination with immune checkpoint inhibitors (e.g., nivolumab, cemiplimab) or chemotherapy.[2][3][4][6][7][9] The vaccine is administered subcutaneously or intradermally in repeated doses and has demonstrated potent immunogenicity with encouraging clinical activity and acceptable safety in phase 1–2 studies, including durable responses and improved survival when combined with PD‑1 blockade in incurable HPV16‑positive cancers.[1][2][4][6][7][9]
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