HARRISON, N.Y., Nov. 14, 2022 /PRNewswire/ — 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, announced today that it will present Phase 2 clinical results of ST101 in recurrent glioblastoma (GBM) during a poster session at the 27th Society for Neuro-Oncology (SNO) Annual Meeting, taking place November 16-20, 2022 in Tampa Bay, Florida.
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 in an ongoing Phase 2 study. These data will be presented in the ST101 poster at the SNO meeting.
Poster Presentation Details:
Title: “Early Signal of Activity From a Phase 2 Study of ST101, a First-In-Class Peptide Antagonist of CCAAT/Enhancer-Binding Protein Β (C/Ebpβ), in Recurrent Glioblastoma (GBM)”
Poster Number: CTNI-49
Session Title/Code: Rapid Report – Session 1
Date/Time: Friday, November 18, 2022, 7:30 PM-9:30 PM ET
More information is available on the SNO website.
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.
About Sapience Therapeutics
Sapience Therapeutics, Inc. is a privately held, clinical-stage biotechnology company focused on discovering and developing peptide therapeutics to address oncogenic and immune dysregulation that drive cancer. Its pipeline of SPEARs™ (Stabilized Peptides Engineered Against Regulation) disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable. Sapience’s lead program, ST101, is a first-in-class antagonist of C/EBPβ that has demonstrated clinical proof-of-concept in multiple indications. For more information on Sapience Therapeutics, please visit www.sapiencetherapeutics.com and engage with us on LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements. Any statements herein other than statements of historical fact could be deemed to be forward-looking statements. These forward-looking statements may include, among other things, statements regarding future events that involve significant risks and uncertainties (including with respect to Sapience’s preclinical and clinical development programs). These forward-looking statements are based on management’s current expectations, and actual results and future events may differ materially as a result of certain factors, including, without limitation, our ability to obtain additional funds, and meet applicable regulatory standards and receive required regulatory approvals. Forward-looking statements speak only as of the date of this press release. Sapience does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise, except as required by law.
Sapience Therapeutics, Inc.:
Barry Kappel, Ph.D., M.B.A.
President and Chief Executive Officer
Media and Investor Contact:
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SOURCE Sapience Therapeutics, Inc.
Released November 14, 2022