On April 16, 2024 ISA reported acceptance of its ISA101b study abstract as an oral presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting (Press release, ISA Pharmaceuticals, APR 16, 2024, View Source [SID1234642095]). This abstract describes results of a randomized trial in advanced head and neck cancer with its lead therapeutic vaccine ISA101b. These results provide key insights in the clinical application of cancer vaccines.
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ISA101b is a cancer vaccine that targets human papillomavirus type 16 (HPV16) positive cancers. It induces strong and specific T-cell immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. ISA Pharmaceuticals sees a clear path forward and is looking to partner ISA101b for Phase 3 clinical development.
Head-and-neck cancer can be a severe and life-threatening disease. HPV16 is a major cause of head-and-neck cancer. Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need. In September 2021 ISA101b was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent and metastatic HPV16 positive OPC.