Sapience Therapeutics Announces First Patient Dosed in Phase 1-2 Clinical Study of ST316
Tarrytown's Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, has announced that the first patient has commenced treatment in its Phase 1-2 study evaluating the Company’s first-in-class antagonist of β-catenin, ST316. Though a principal driver of many cancers, β-catenin has evaded drug discovery efforts for more than 30 years. ST316 is designed to selectively target oncogenic activation of the Wnt/β-catenin signaling pathway, without impacting its activity in normal cells.
ST316-101 (NCT05848739) is a first-in-human, open-label, Phase 1-2 dose-escalation and expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 dose-escalation portion of the study will test various dose levels of ST316 in patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. With its first patient dosed on June 5, 2023, the Company expects to complete the Phase 1 portion of the study in the second half of 2024. Following completion of the study’s Phase 1 portion, the recommended dose will advance to the Phase 2 portion of the study, in which ST316 will be tested in four advanced solid tumor types that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. Sapience is conducting the Phase 1 study across several sites in the United States.
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