TARRYTOWN, N.Y., May 4, 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, announced today that it was awarded a $2 million, two-year Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). The proposed non-clinical studies will investigate pharmacodynamic biomarkers for ST316, a first-in-class β-catenin antagonist, and evaluate the impact of ST316 on the tumor microenvironment (TME) in patient-derived cancer models.
“This award provides further validation of our novel approach with ST316 to impact the Wnt/β-catenin signaling pathway, a known oncogenic driver of many cancers and a key regulator of the tumor microenvironment,” said Jim Rotolo, Ph.D., SVP, Translational Pharmacology and Head of Research of Sapience Therapeutics. “ST316 has tremendous therapeutic promise, with a robust preclinical data package that includes a favorable safety profile and significant anti-tumor activity. We look forward to building upon these data with this grant award and evaluating ST316 in patients in our upcoming Phase 1-2 clinical study.”
ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator BCL9, a complex that drives oncogenesis in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. In March 2023, Sapience announced that it received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1-2 clinical trial of ST316 for the treatment of solid tumors. In addition, at the American Association for Cancer Research (AACR) Annual Meeting 2023, Sapience presented late-breaking data on ST316 highlighting its immunotherapeutic potential.
The award will utilize patient-derived xenograft (PDX) models to investigate pharmacodynamic (PD) biomarkers and evaluate the impact of ST316 on the TME, namely macrophage polarization, tumor infiltrating lymphocyte (TIL) expression in tumors and the impact in combination with a PD-1 inhibitor. This grant was supported by the National Cancer Institute of the National Institutes of Health under Award Number 2R44CA265503-02A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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. Disruption of the interaction between BCL9 and β-catenin with ST316 reduces oncogenic Wnt-signaling, suppressing transcription of Wnt target genes resulting in tumor cell death and a pro-inflammatory tumor microenvironment, without disruption of homeostatic Wnt function.
In the second quarter of 2023, the Phase 1 dose-escalation portion of the Phase 1-2 study will begin enrolling patients with selected advanced solid tumors likely to harbor abnormalities of the Wnt/β-catenin signaling pathway. The Phase 2 dose-expansion portion aims to continue to assess the safety of ST316 as well as proof of concept in four specific tumor types known to harbor abnormalities of the Wnt/β-catenin signaling pathway.
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 advanced solid tumors. Sapience has received IND clearance to proceed with its second program, ST316, a first-in-class antagonist of β-catenin. 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
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