Cancer Vaccine Granted Orphan Drug Designation by FDA for Treatment of Multiple Myeloma
Posted: Tuesday, June 5, 2018
Recently, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to Sellas Life Sciences’ cancer vaccine galinpepimut-S for the treatment of multiple myeloma. Galinpepimut-S, which is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, has also received Orphan Drug designation for the treatment of acute myeloma leukemia and malignant pleural mesothelioma.
Galinpepimut-S has been tested as maintenance therapy in 19 patients with high-risk myeloma who had at least stable disease after a stem cell transplant, in a phase II trial (ClinicalTrials.gov identifier NCT01827137). A median progression-free survival of 23.6 months—compared with a historic patient cohort of about 12 months—was reported. Galinpepimut-S appears to stimulate time-dependent and T-cell immune responses as well as cross-epitope T-cell reactivity. According to a news story in Myeloma Research News, 88% of these 19 patients remained alive 18 months after receiving the vaccine.
