Sapience Therapeutics, Inc.

TARRYTOWN, N.Y., Oct. 3, 2024 /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, today announced its participation at the 4th Annual Needham Private Biotech Company Virtual 1x1 Forum, taking place October 8-9, 2024. Company management will participate in one-on-one meetings with investors during the conference. 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. With in-house discovery capabilities, Sapience has built a pipeline of therapeutic candidates called SPEARs™ (Stabilized Peptides Engineered Against Regulation) that disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable, and can direct cargo to cell surface targets with their new class of molecule called SPARCs™ (Stabilized Peptides Against Receptors on Cancer), enabling delivery of payloads such as α-particles to cancer cells. Sapience is advancing two clinical programs through Phase 2 studies: ST316, a first-in-class antagonist of β-catenin, and ST101, a first-in-class antagonist of C/EBPβ. For more information on Sapience Therapeutics, please visit and engage with us on LinkedIn. Media and Investor Contact: Amy Conrad Juniper Point (858) 366-3243 [email protected] SOURCE Sapience Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

-ST316 will be evaluated in several combinations and lines of treatment- TARRYTOWN, NY, USA I October 1, 2024 I 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 the first patient has been enrolled in its Phase 2 dose expansion study evaluating ST316, the Company’s first-in-class antagonist of β-catenin.  Enrollment of the study’s Phase 1 monotherapy dose escalation portion was completed in July 2024. ST316 is designed to selectively shut down the Wnt/β-catenin signaling pathway in tumor cells but not in normal cells, allowing for anti-cancer activity without the toxicity related to broad inhibition of this pathway. The Wnt/β-catenin signaling pathway is one of the most active pathways in several cancers and drives more than 80% of colorectal cancers (CRCs), the first indication to be evaluated in the ST316 Phase 2 expansion. There are more than 1 million people living with CRC in the United States, with another 150,000 expected to be diagnosed this year alone. Dr. Abi Vainstein-Haras, Sapience’s Chief Medical Officer, stated, “The promising results seen in our Phase 1 study demonstrate ST316’s potential to be an effective therapy for Wnt pathway-driven cancers, including CRC among others.  Given ST316’s favorable safety and tolerability profile, together with robust pre-clinical data, Sapience is committed to maximizing the potential of ST316 in various therapeutic combinations across lines of treatment.” “CRC patients who are refractory to current therapies desperately need new options like ST316,” said Dr. Barry Kappel, Sapience’s founder and Chief Executive Officer. “With CRC being the second-leading cause of cancer death in the United States, and with alarming increases in incidence among younger Americans, we are dedicated to widening the treatment options for this devastating disease.” ST316-101 ( NCT05848739 ) is a first-in-human, open-label, Phase 1-2 dose-escalation and expansion  study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 dose escalation portion of the study tested various dose levels of ST316 in patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway, including CRC.  The Phase 1 portion completed enrollment in July 2024.  In the Phase 2 dose expansion portion of the study, ST316 is being tested in CRC patients in combination with relevant standards of care and in multiple lines of treatment.  Sapience is conducting the Phase 2 study across several sites in the United States. About ST316 ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex responsible for driving oncogene expression in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. ST316 exposure in cancer cells prevents BCL9-driven nuclear localization of β-catenin and inhibits formation of the Wnt enhanceosome protein complex. Disruption of this interaction selectively suppresses the transcription of oncogenic Wnt target genes that regulate proliferation, migration, invasion and the metastatic potential of tumor cells, as well as genes that regulate the immunosuppression of the tumor microenvironment. ST316 creates a pro-immune tumor microenvironment and in preclinical models has shown to be synergistic with checkpoint inhibition. Due to its selectivity and downstream modulation of the Wnt/β-catenin pathway, ST316 presents an opportunity to safely and effectively target Wnt/β-catenin driven cancers without the toxicities previously seen with other Wnt pathway agents. 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.  With in-house discovery capabilities, Sapience has built a pipeline of therapeutic candidates called SPEARs™ (Stabilized Peptides Engineered Against Regulation) that disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable, and can direct cargo to cell surface targets with their new class of molecule called SPARCs™ (Stabilized Peptides Against Receptors on Cancer), enabling delivery of payloads such as α-particles to cancer cells. Sapience is advancing two clinical programs through Phase 2 studies: ST316, a first-in-class antagonist of β-catenin, and ST101, a first-in-class antagonist of C/EBPβ. For more information on Sapience Therapeutics, please visit www.sapiencetherapeutics.com and engage with us on LinkedIn . SOURCE: Sapience Therapeutics

-Data demonstrates durable responses across 3 cohorts of patients with recurrent and newly diagnosed GBM- -Data supports continued clinical development of ST101 as a backbone treatment in combination with standard-of-care and immune-oncology agents- TARRYTOWN, N.Y., June 1, 2024 /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, today presented new clinical and biomarker data from its ST101 Phase 2 study in GBM at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. ST101 is a first-in-class antagonist of C/EBPβ, currently being evaluated in patients with recurrent and newly diagnosed GBM in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279). Dr. Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center, and Principal Investigator of the ST101-101 clinical study, said, "ST101's clinical activity in GBM patients in the expansion and window-of-opportunity studies is highly encouraging, showing durable responses, a compelling survival benefit, and remodeling of the tumor microenvironment to an immune-active state. I am pleased to present this data at ASCO and look forward to ST101 advancing into Phase 2b combination studies." Dr. Abi Vainstein-Haras, Sapience's Chief Medical Officer, added, "ST101's impressive clinical results and favorable safety profile add to the growing body of data supporting C/EBPβ as a promising target for the treatment of GBM. Our biomarker results demonstrate a clear impact on the tumor microenvironment, providing rationale to explore ST101 in combination with immune-oncology agents, such as checkpoint inhibitors. We look forward to advancing a comprehensive clinical development program for ST101 with the goal of extending survival and improving outcomes for patients with this devastating disease." Oral presentation highlights include: Presentation Title: "Efficacy and biomarker analysis of phase 2 (P2) and window-of-opportunity (WoO) cohorts of patients with glioblastoma (GBM) treated with ST101, an inhibitor of the transcription factor C/EBPβ" Abstract Number for Publication: 2011 Session Type and Title: Clinical Science Symposium – Advancing Trial Design: Illuminating Tumor Evolution in Central Nervous System Cancer Date and Time: 6/1/2024, 3:00 PM-4:30 PM CDT Presenting Author: Fabio M. Iwamoto, MD, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center ST101 has the potential to be a well-tolerated treatment option for patients with GBM Outcome data presented from multiple cohorts of GBM patients (n=42) Main study: monotherapy in recurrent GBM, n=30 2 patients with PRs, on study treatment for 55 weeks and 59+ weeks 7 patients with SD with on study treatment for a range of 13-79 weeks 53% OS and 40% OS at 9 and 12 months, respectively Window-of-Opportunity Study: ST101 monotherapy in recurrent GBM, n=6 2 PRs (1 unconfirmed), 1 ongoing 2 SD, 1 ongoing Median OS ~12 months; 3/6 patients alive (41-62 wks) Window-of-Opportunity Study: combination of ST101 with standard-of-care (radiation and temozolomide) in newly diagnosed GBM, n=6 1 CR, duration ~1 year and ongoing 4 SD, 3 ongoing 5/6 patients alive (25-57 wks) Biomarker data presented from Window-of-Opportunity study cohorts ST101 crosses the BBB and penetrates tumor tissue as shown by IHC Target (C/EBPβ) engagement and degradation shown by IHC Modulation of the tumor immune microenvironment to promote anti-tumor activity The slide presentation is available under the Presentations tab on the Sapience Therapeutics website. About ST101 ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in patients with newly diagnosed and recurrent GBM (ndGBM and rGBM) in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279). In an ongoing window-of-opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in ndGBM, with patients receiving ST101 before and after surgical resection. ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and orphan designations for glioma from the U.S. FDA and the European Commission. 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. With in-house discovery capabilities, Sapience has built a pipeline of therapeutic candidates called SPEARs™ (Stabilized Peptides Engineered Against Regulation) that disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable, and can direct cargo to cell surface targets with their new class of molecule called SPARCs™ (Stabilized Peptides Against Receptors on Cancer), enabling delivery of payloads such as α-particles to cancer cells. Sapience is advancing its lead programs, ST316, a first-in-class antagonist of β-catenin, and ST101, a first-in-class antagonist of C/EBPβ, through Phase 1-2 clinical trials. For more information on Sapience Therapeutics, please visit 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. Media and Investor Contact: Amy Conrad Juniper Point (858) 366-3243 [email protected] SOURCE Sapience Therapeutics, Inc.