FMPV-1 + GM-CSF

FMPV-1 + GM-CSF is an investigational cancer vaccine formulated as a combination of a synthetic peptide vaccine (FMPV-1) and granulocyte-macrophage colony-stimulating factor (GM-CSF) administered as two separate, co-located intradermal injections. FMPV-1 is a 24-amino-acid synthetic peptide designed to generate T cell responses specific to frameshift-mutated transforming growth factor β receptor 2 (TGFβR2), a common neoantigen in microsatellite instability-high (MSI-H) cancers. GM-CSF serves as an immune adjuvant to enhance the immunogenicity of the peptide vaccine. The combination aims to induce robust, mutant TGFβR2-specific T cell activation and memory formation, thereby targeting and destroying tumor cells that harbor these mutations. Developed for both therapeutic and prophylactic applications, notably in colorectal and other MSI-H cancers, this vaccine has shown the induction of persistent vaccine-specific T cell responses in first-in-human studies and is being evaluated in combination with pembrolizumab for metastatic MSI-H colorectal cancer[1][2][4].