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GLSI-100 is an investigational cancer immunotherapy vaccine designed to prevent recurrence in patients with HER2/neu-positive breast cancer. It consists of a nine amino acid peptide (GP2), derived from the transmembrane domain of the HER2/neu protein (amino acids 654–662), combined with granulocyte-macrophage colony stimulating factor (GM-CSF; sargramostim). The mechanism involves stimulating an immune response—specifically activating CD8+ cytotoxic T lymphocytes—to recognize and destroy HER2/neu-expressing tumor cells. GM-CSF acts as an immunoadjuvant by promoting antigen-presenting cell proliferation and enhancing the immune response to GP2. Clinical trials have shown that GLSI-100 is well-tolerated, with no serious adverse events attributed to treatment, and has demonstrated a significant reduction in metastatic breast cancer recurrence rates compared to standard therapies[1][3][4][5][6].
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