On December 6, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead program investigating ST101 for the treatment of recurrent glioblastoma (GBM) (Press release, Sapience Therapeutics, DEC 6, 2021, View Source [SID1234596504]). ST101 is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors, which includes a GBM expansion cohort.

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In the ongoing Phase 1-2 study, ST101 demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients with refractory solid tumors.

"Glioblastoma is the most aggressive, fatal form of brain cancer with limited-to-no therapeutic options. With the efficacy data from solid tumors and its ability to cross the blood-brain barrier, ST101 could meaningfully improve outcomes for patients battling this debilitating disease and we look forward to advancing it into Phase 2," said Dr. Barry Kappel, Sapience’s CEO and President.

Dr. Gina Capiaux, PhD, Sapience’s Head of Regulatory Affairs added, "This is an exciting regulatory milestone for our program. Fast Track designation for ST101 highlights this unmet need and allows us to work closely with the FDA to deliver this novel therapy to people with GBM as soon as possible."

Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Sapience previously received Orphan Drug Designation from the FDA and European Commission for ST101 for the treatment of glioma.

About Glioblastoma
Glioblastomas are a class of malignant glioma and represent the most common and serious type of primary brain tumors. GBMs account for approximately 14% of all primary brain and Central Nervous System (CNS) tumors and 50% of all malignant brain tumors. Despite standard treatments including surgery, chemotherapy, and radiation, GBM has a rapid progression and high mortality with a median survival less than 8 months and a five-year survival rate of 6.6%.

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation by the European Commission for the treatment of glioma.