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AE37 is a therapeutic cancer peptide-based vaccine designed to stimulate the immune system against cancers that express the human epidermal growth factor receptor 2 (HER2), such as breast cancer. It consists of a synthetic epitope derived from the intracellular domain of the HER2 protein (amino acids 776–790), covalently linked to an immunostimulatory li-Key peptide sequence. This design enhances antigen presentation and immune activation by increasing binding affinity for major histocompatibility complex (MHC) class II molecules. Unlike other vaccines that primarily elicit CD8+ cytotoxic T cell responses via MHC class I pathways (e.g., E75), AE37 specifically stimulates CD4+ helper T cells through MHC class II presentation. This leads to both antibody and cellular immune responses directed at tumor cells expressing HER2[1][3][5][7]. The addition of granulocyte-macrophage colony-stimulating factor (GM-CSF) further boosts its immunoadjuvant effect[1]. Developed originally by Antigen Express (a subsidiary of Generex Biotechnology), with involvement from Merck AG and NuGenerex Immuno-Oncology among others[4], it has been investigated primarily for adjuvant therapy in breast cancer patients who are clinically disease-free after standard treatment but at risk for recurrence. Clinical trials have reached phase II in breast cancer and triple-negative breast cancer; development was discontinued in ovarian cancer[4].
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