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**galinpepimut-s + montanide + sargramostim** is a combination immunotherapy regimen consisting of a synthetic multivalent WT1 peptide vaccine (galinpepimut-S), the immunologic adjuvant Montanide, and the immune growth factor sargramostim (recombinant human granulocyte-macrophage colony-stimulating factor, also known as GM-CSF)[2][6]. - **Galinpepimut-S:** A synthetic peptide vaccine that targets the Wilms Tumor 1 (WT1) protein, an immunogenic antigen highly overexpressed in diverse hematological malignancies (e.g., AML) and solid tumors (e.g., mesothelioma, ovarian cancer)[3][4]. It contains four peptides, including modified ones designed to elicit strong CD4+/CD8+ T-cell responses against WT1-expressing cancer cells, aiming to induce tumor-specific cytotoxicity and immunological memory[2][3][4][6]. - **Montanide:** An oil-based adjuvant used to enhance immune response to peptide vaccines[2][6]. - **Sargramostim:** Recombinant GM-CSF administered to potentiate the vaccine's activity by recruiting and activating antigen-presenting cells at the injection site[2][6]. This regimen is under clinical investigation as maintenance/adjuvant therapy post-remission or in combination with other agents (especially immune checkpoint inhibitors) for the prevention of relapse and promotion of anti-tumor immunity in cancers expressing WT1. Clinical trials have targeted acute myeloid leukemia (AML), malignant pleural mesothelioma (MPM), and other WT1-positive cancers[2][3][4][5][6][7]. The vaccine component has orphan drug status in the US for mesothelioma[2]. Sellas Life Sciences is the principal company developing this immunotherapy strategy[3][4][5].
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