Galinpepimut-S (GPS; Sellas Life Sciences Group), an investigational treatment for multiple myeloma (MM), has been granted Fast Track designation by the Food and Drug Administration (FDA).
GPS is a heteroclitic multivalent, multi-peptide cancer immunotherapeutic agent composed of 4 peptides. The treatment targets the Wilms Tumor 1 (WT1) protein. As WT1 is present in an array of tumor types, the Company believe GPS has the potential to be a broad immunotherapy.
An open-label Phase 2 study of GPS was conducted in 19 individuals with MM who had high-risk cytogenetics at initial diagnosis and remained at least minimal residual disease-positive after a successful autologous stem cell transplant. Results showed a median progression free survival of 23.6 months; to date, median overall survival has not been reached. GPS stimulated CD4+ T cell or CD8+ T cell immune responses specific for all 4 WT1 peptides within GPS. Additionally, GPS stimulated similar IRs against the two counterpart native peptides.
Speaking about the Fast Track designation, Angelos Stergiou, MD, ScD hc, President and CEO of Sellas said, “We are fully committed to working closely with the FDA as we continue development of our potential first-in-class novel WT1-targeting cancer vaccine for select high-risk MM patients in the post-autotransplant maintenance setting after standard first-line treatment.”
For more information visit Sellaslifesciences.com.