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The HER2 ICD vaccine is a plasmid DNA-based cancer immunotherapy designed to induce an immune response against the intracellular domain (ICD) of the human epidermal growth factor receptor 2 (HER2/ERBB2). The primary mechanism involves encoding the HER2/neu protein's intracellular region to elicit a cytotoxic T lymphocyte (CTL) response specifically targeting tumor cells overexpressing or expressing low levels of HER2. The most studied formulation is pNGVL3-hICD (AST-301), which has demonstrated safety and immunogenicity in phase I clinical trials for patients with advanced-stage breast cancer. The intermediate dose (100 μg) was associated with robust and persistent immunity in most patients. Clinical development focuses on preventing recurrence and enhancing treatment outcomes in breast cancer, particularly as adjuvant therapy after standard treatments such as trastuzumab[1][4][5][6].
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