Sapience Therapeutics Receives FDA Fast Track Designation for ST101 for Advanced Cutaneous Melanoma
Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its lead program, investigating ST101 for the treatment of advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy.
This is the second FTD designation received for the ST101 program, following FTD for recurrent glioblastoma (GBM), announced in early December 2021. ST101 is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors, which includes expansion cohorts in patients with cutaneous melanoma and refractory GBM.
Dr. Barry Kappel, Sapience's CEO and President, commented, "Melanoma is the fifth most diagnosed cancer in the U.S., with more than 100,000 new cases per year, and no well-established standard of care treatment regimen. We believe we have a significant opportunity to deliver a novel therapeutic option with ST101, which has a durable clinical efficacy and an excellent safety profile, for melanoma patients whose disease has progressed following treatment with anti-PD-1 therapy."
Dr. Gina Capiaux, PhD, Sapience's Head of Regulatory Affairs added, "This is the second Fast Track designation received for ST101, underscoring the advancement of our ST101 program and its potential therapeutic benefit for both melanoma and GBM patients. We are grateful for the opportunity to quickly advance the development of ST101 for patients in need."
December 15, 2021
