HARRISON, N.Y., Oct. 4, 2022 /PRNewswire/ — Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immunogenic dysregulation that drive cancer, announced today that it was awarded a Small Business Innovative Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to conduct non-clinical studies to identify predictive and pharmacodynamic biomarkers of activity of ST101, a peptide antagonist of C/EBPβ, in patient-derived breast cancer models.
“We are grateful to have been awarded a Phase 2 SBIR grant from the NIH for ST101, which represents a continuation of our initial grant that supported the advancement of ST101 through Phase 1 clinical studies,” said Jim Rotolo, Ph.D., VP, Translational Pharmacology and Head of Research of Sapience Therapeutics. “This grant allows us to further evaluate the efficacy of ST101 in patient-derived breast cancer models, which will inform patient selection criteria to enhance ST101’s ability to treat multiple types of difficult cancers.”
Sapience CEO and President, Dr. Barry Kappel added, “With this funding, we aim to further showcase the therapeutic promise of disrupting C/EBPβ-driven oncogenic and immunosuppressive activity with ST101 in clinically relevant breast cancer models. We look forward to advancing ST101 through Phase 2 and towards patients in need.”
This grant was supported by the National Cancer Institute of the National Institutes of Health under Award Number 2R44CA250786-02. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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 immunogenic 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
Released October 4, 2022