On October 13, 2022 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, reported that an abstract on Phase 1-2 clinical results of ST101 has been selected for presentation at the upcoming 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place October 26-28, 2022 in Barcelona, Spain (Press release, Sapience Therapeutics, OCT 13, 2022, View Source [SID1234621995]).
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Poster Presentation Details:
Title: "Efficacy signals, long-term exposure and safety data from a phase 1-2 study of a cell-penetrating peptide antagonist of CEBPβ, a novel target, in patients (pts) with refractory solid tumors"
Abstract Number: 230
Session Title/Code: Molecular Targeted Agents 2
Date/Time: Thursday, October 27, 2022, 10am-5pm
Regular abstracts are available on the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) website at Home Page – 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium.
About ST101
ST101, a first-in-class antagonist of C/EBPβ, is 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 (NCT04478279). ST101-101 is an open-label, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the ongoing dose escalation part of the study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.
ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.