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ES2B-C001 is a first-in-class therapeutic vaccine candidate designed to treat cancers that overexpress the human epidermal growth factor receptor 2 (HER2), with an initial focus on HER2-positive breast cancer. It is based on a virus-like particle (VLP) platform displaying the extracellular domain of HER2. The vaccine aims to induce a strong and durable polyclonal antibody response against HER2 by breaking immune tolerance and stimulating both humoral and cellular immunity. Preclinical studies have shown that ES2B-C001 can effectively inhibit tumor growth and metastasis in mouse models of HER2-positive breast cancer, including tumors resistant to trastuzumab. The drug is currently being evaluated in a first-in-human phase I clinical trial for safety, tolerability, immunogenicity, and preliminary antitumor activity in patients with metastatic HER2-expressing breast cancer[5][4][3].
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