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AST-301 (pNGVL3-hICD) is a therapeutic DNA plasmid vaccine designed to target the intracellular domain (ICD) of the human epidermal growth factor receptor 2 (HER2/ERBB2) protein. Developed by Aston Sci. Inc. in collaboration with the University of Washington, the vaccine consists of a circular DNA plasmid (pNGVL3) encoding the 1790 base pair region of the HER2 ICD. It is intended to stimulate a Th1-polarized T-cell immune response against HER2-expressing tumor cells, particularly in patients with HER2-low breast cancer and gastric cancer. The vaccine is typically administered intradermally alongside recombinant human granulocyte-macrophage colony-stimulating factor (rhuGM-CSF) as an adjuvant to enhance the recruitment and activation of antigen-presenting cells. Clinical development focuses on the adjuvant setting to prevent recurrence by eradicating residual microscopic disease.
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