FDA Orphan Drug Designation Granted to ST101 for Advanced Cutaneous Melanomas

Source: Targeted Oncology, December 2021

ST101 was granted a fast track designation based on preliminary data of an ongoing phase 1/2 trial.

The FDA granted a fast track designation to ST101 for the treatment of advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, according to a press release by Sapience Therapeutics, Inc.

ST101 is a peptide antagonist of C/EBPB. The agent has demonstrated clinical proof of concept with a confirmed partial response in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. It was previously granted an orphan drug designation.

“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 glioblastoma multiforme patients. We are grateful for the opportunity to quickly advance the development of ST101 for patients in need,” said Gina Capiaux, PhD, sapience’s Head of Regulatory Affairs, in a press release.

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