The U.S. Food and Drug Administration has granted Fast Track designation to SELLAS Life Sciences‘ WT1 cancer vaccine — galinpepimut-S — as a possible treatment of malignant pleural mesothelioma. This action follows the FDA placing galenpepimut-S on “fast track,” or accelerated development, for the treatment of acute myeloid leukemia in June.
Fast Track designation is granted to new drugs or biologics intended to treat serious or life-threatening diseases that might address an unmet medical need, and is meant to expedite the drug’s development and review processes.
“SELLAS has made rapid progress against its strategic goals in the past six months, and this milestone follows the FDA’s Fast Track designation for AML, and recent orphan drug designations in the US and Europe for galinpepimut-S in both AML and MPM,” Dr. Angelos M. Stergiou, MD, vice chairman and chief executive officer of SELLAS, said in a press release. “Galinpepimut-S is demonstrating its potential as an anti-cancer agent, with outstanding results regarding survival, immunological responses, and safety in AML and MPM patients.”
The WT1 antigen is a widely expressed cancer antigen in multiple malignancies, and is ranked as the No. 1 target for immunotherapy by the National Cancer Institute (NCI). SELLAS’ WT1 vaccine is designed to induce a strong T-cell immune response against the cells expressing this protein, and has shown promise in Phase 1 and Phase 2 clinical trials, helping patients stay in remission after their cancer has been removed and they underwent subsequent treatment, so as to prolong their overall survival.
Recently, SELLAS presented data from the Phase 2 malignant pleural mesothelioma study of galinpepimut-S (NCT01890980) at the 2016 Annual Meeting of the American Society of Clinical Oncology and 2016 International Mesothelioma Interest Group.
The randomized, double-blind, placebo-controlled study enrolled 40 patients at the Memorial Sloan Kettering Cancer Center and M.D. Anderson Cancer Center, and showed that galinpepimut-S induced a median overall survival of 24.8 months, a number that was reduced to 16.6 months in patients in the study’s control arm.
Researchers also revealed that galinpepimut-S was well-tolerated, activated CD8+ and CD4+ T-cells, and induced significantly improved survival in patients with complete tumor resection.
“This Fast Track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma. We are excited to begin the pivotal Phase 3 trial in patients with MPM in the second half of 2017 and expect the Fast Track designation to expedite the time to market, thereby enhancing the value proposition of galinpepimut-S in this indication,” Stergiou said.