Sapience Therapeutics Receives FDA Orphan Drug Designation for ST101 for the Treatment of Advanced Melanoma
Sapience Therapeutics, Inc. recently announced that the FDA has granted Orphan Drug Designation (ODD) to its lead program, ST101, for the treatment of advanced melanoma for patients in stages IIB through IV. This is the third orphan drug designation received for the ST101 program, following orphan designations by the FDA for the treatment of AML in April 2018 and for glioma in June 2020.
ST101 is a first-in-class peptide antagonist of C/EBPβ currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors that are refractory to standard therapy (NCT04478279). This study includes expansion cohorts that are currently dosing and enrolling patients with GBM, cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer.