FMPV-1

FMPV-1 is a peptide-based investigational cancer vaccine designed to activate T cell responses specifically against the transforming growth factor β receptor 2 (TGFβR2) frameshift mutation, which is commonly found in microsatellite instability-high (MSI-H) cancers such as colorectal and gastric cancers. The vaccine aims to induce anti-cancer immune responses by targeting neoantigens resulting from these frameshift mutations. In clinical studies, FMPV-1 has been administered with granulocyte-macrophage colony-stimulating factor (GM-CSF) as an adjuvant to enhance immunogenicity. Early-phase trials have demonstrated that FMPV-1/GM-CSF can generate robust T cell memory responses specific for the mutant TGFβR2 epitope, with a favorable safety profile characterized mainly by mild injection site reactions. The drug is being developed primarily for use in patients with MSI-H tumors harboring TGFβR2 frameshift mutations and is also being studied in combination with pembrolizumab, an immune checkpoint inhibitor[1][6][7][8].