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HER2-VLP (also known as ES2B-C001 or AV001) is a first-in-class therapeutic cancer vaccine and active immunotherapy designed to treat HER2-expressing cancers, primarily breast cancer. Developed by ExpreS2ion Biotechnologies in collaboration with AdaptVac, the vaccine utilizes a virus-like particle (VLP) platform derived from the AP205 phage to display the full extracellular domain (subdomains I-IV) of the human HER2 protein at high density. This directional, high-density display is achieved using a SpyTag/SpyCatcher conjugation system, which overcomes immune tolerance and stimulates a robust, durable polyclonal antibody response against multiple epitopes of the HER2 receptor. In clinical development, HER2-VLP is being evaluated in Phase I trials for patients with HER2-expressing metastatic breast cancer, both as a monotherapy and in combination with adjuvants like Montanide or standard-of-care therapies such as trastuzumab deruxtecan.
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