On March 16, 2023 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 it will present two late-breaking research posters during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19, 2023, in Orlando, Florida (Press release, Sapience Therapeutics, MAR 16, 2023, View Source [SID1234628962]).
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Poster Presentation Details:
Title: "ST101, a peptide antagonist of novel I/O target C/EBPβ, reprograms MDSCs and promotes an immunoactive tumor microenvironment"
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Session Date and Time: Tuesday April 18, 2023, 1:30 PM – 5:00 PM
Location: Poster Section 34
Abstract Presentation Number: LB236
Title: "Immunotherapeutic potential of ST316, a peptide antagonist of β-catenin"
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1
Session Date and Time: Sunday April 16, 2023, 1:30 PM – 5:00 PM
Location: Poster Section 35
Abstract Presentation Number: LB016
Abstracts and full session details are available through the AACR (Free AACR Whitepaper) Annual Meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2023 | Meetings | AACR (Free AACR Whitepaper)
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.
About ST316
ST316, a first-in-class β-catenin antagonist, is in Phase 1 clinical development following the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration in March 2023. β-catenin is a critical member of the canonical Wnt signaling pathway, a well-known development stage pathway that has been considered an "undruggable" cancer target, as small molecules have proven ineffective or toxic. Preventing β-catenin translocation to the nucleus through disruption of the interaction between BCL9 and β-catenin allows for disruption of oncogenic WNT-signaling, resulting in tumor cell death and a pro-inflammatory tumor microenvironment – without disruption of homeostatic WNT-function. ST316 suppresses transcription of Wnt target genes regulating proliferation, migration, invasion and the metastatic potential of tumor cells, as well as genes regulating the immunosuppression of the tumor microenvironment.
In preclinical studies, ST316 was well tolerated and demonstrated significant in vitro and in vivo anti-tumor activity. Sapience expects to begin patient dosing in the Phase 1 dose escalation portion of the Phase 1-2 study in the first half of 2023.