SELLAS Life Sciences announced that their novel drug candidate, galinpepimut-S (GPS), has been granted Orphan Drug designation for the treatment of multiple myeloma (MM).
GPS was previously been granted Orphan Drug and Fast Track designation for acute myeloid leukemia (AML) and malignant plural mesothelioma (MPM). It targets the Wilms Tumor 1 (WT1) protein which is present in a variety of tumor types.
The Company recently released results from a Phase 2 open-label study which involved 19 multiple myeloma patients who had high-risk cytogenetics at diagnosis and remained at least minimal residual disease (MRD)-positive after a successful autologous stem cell transplant (ASCT). Results showed a median of 23.6 months for progression-free survival; GPS stimulated CD4+ T cell or CD8+ T cell immune responses specific for all 4 WT1 peptides within GPS.
“Receiving orphan drug designation for the treatment of multiple myeloma is a significant regulatory milestone in the development of GPS,” said Angelos Stergiou, MD, ScD, President and CEO of SELLAS. GPS is licensed from Memorial Sloan Kettering Cancer Center. The Company states that Phase 3 clinical trials are planned for GPS in both AML and MPM.
For more information visit Sellalifesciences.com.