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The GM-CSF-secreting HER-2+ breast cancer vaccine is an investigational allogeneic, whole-cell cancer immunotherapy developed at Johns Hopkins University. It is composed of a 2:1 mixture of two human breast cancer cell lines, 2T47D-V and SKBR3-7, which have been genetically modified via plasmid DNA transfection to secrete bioactive levels of granulocyte-macrophage colony-stimulating factor (GM-CSF). The vaccine is designed to deliver a broad array of breast cancer-associated antigens, primarily HER2/neu, alongside GM-CSF to recruit and activate antigen-presenting cells (such as dendritic cells) at the injection site, thereby driving a robust, antigen-specific T-cell and antibody response against HER2-overexpressing breast cancer cells. It has been evaluated in Phase I and Phase II clinical trials (e.g., NCT00399529) for the treatment of HER2-positive metastatic breast cancer, often in combination with low-dose cyclophosphamide (to deplete regulatory T cells) and trastuzumab.
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