CEBPB

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. 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 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 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. Contacts Sapience Therapeutics, Inc.: Barry Kappel, Ph.D., M.B.A. President and Chief Executive Officer [email protected] Media and Investor Contact: Amy Conrad Juniper Point (858) 366-3243 [email protected] SOURCE Sapience Therapeutics, Inc.

HARRISON, N.Y., Sept. 19, 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 preclinical data on ST101, the company's first-in-class peptide antagonist of C/EBPβ, were published online in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research. The published data describe preclinical evidence to support the advancement of ST101 as a novel therapy for treating advanced solid tumors. The full manuscript titled "Anti-cancer activity of ST101, a novel antagonist of CCAAT/enhancer binding protein β", can be found online here. The data in the manuscript detail ST101-antagonism of CCAAT/Enhancer Binding Protein β (C/EBPβ), a basic leucine zipper family transcription factor that is upregulated or overactivated in many cancers, resulting in gene transactivation that drives oncogenesis. ST101 binds C/EBPβ, preventing its dimerization and enhancing ubiquitin-proteasome dependent C/EBPβ degradation. ST101 exposure significantly decreases expression of C/EBPβ target genes including genes responsible for survival, transcription factors and cell cycle-related proteins. The result of ST101 exposure is potent, tumor-specific in vitro cytotoxic activity in cancer cell lines including glioblastoma, breast, melanoma, prostate, and lung cancer, while normal human immune and epithelial cells are not impacted. In vivo xenograft models indicate that ST101 exposure results in potent tumor growth inhibition or regression, both as a single agent and in combination studies. "The publication of ST101 in Molecular Cancer Therapeutics is an exciting achievement, highlighting the tremendous unmet need for novel therapies to treat solid tumor cancers and the role that ST101 can play to fill this need," said Jim Rotolo, Ph.D., Sapience's VP, Translational Pharmacology and Head of Research. "We are thrilled to publish the mechanism of action of ST101 and showcase the therapeutic promise of disrupting C/EBPβ-driven oncogenic activity. We look forward to reporting and publishing additional data on ST101 and advancing the program through its ongoing Phase 1-2 study." In its ongoing Phase 1-2 study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM, a durable RECIST 1.1-confirmed partial response in a patient with cutaneous melanoma and long-lasting stable disease in several additional patients. About ST101 and the Phase 1-2 Study 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.

HARRISON, N.Y., Aug. 8, 2022 /PRNewswire/ -- Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of novel peptide therapeutics to address difficult-to-treat cancers, announced today that the company will conduct a sub-study of its ongoing Phase 1-2 clinical trial of ST101 in recurrent and newly diagnosed GBM patients. The sub-study will be conducted by Sapience in collaboration with principal investigators at Columbia University and Northwestern University. Partial funding for the sub-study was awarded to Fabio Iwamoto, Principal Investigator at Columbia University, through a research grant from the Ben and Catherine Ivy Foundation. The study is a multi-site, open-label surgical sub-study of the Phase 1-2 protocol ST101 to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in 18 patients with recurrent (n=6) and newly diagnosed GBM (n=12). The primary objectives of the study will be to evaluate the safety and tolerability of ST101 as monotherapy in recurrent GBM patients post resection and in newly diagnosed GBM patients in combination with radiation ± temozolomide post resection. The secondary objectives of the study will be to determine the penetration of ST101 in the brain and its correlation with plasma levels. In both study arms, patients will be resected following two to four doses of ST101 and will continue on ST101 following surgery. "We are thrilled to continue to evaluate the therapeutic potential of ST101, which has demonstrated very promising clinical data in the ongoing Phase 1-2 study with confirmed partial responses in multiple tumor types, including GBM. In the surgical sub-study, we aim to demonstrate further evidence of ST101's ability to penetrate the brain and inhibit transcription of C/EBPβ, which is a master regulator of GBM tumors," said Fabio Iwamoto, Principal Investigator at Columbia University. "Our team at Columbia remains very excited about our work with Sapience and we look forward to continuing to deliver clinical benefit to cancer patients with ST101." ST101 is a first-in-class peptide antagonist of C/EBPβ with a dual mechanism of action. ST101 antagonism of C/EBPβ promotes (1) a more favorable immune tumor microenvironment by inhibiting formation of immunosuppressive myeloid-derived suppressor cells (MDSCs) and (2) cytotoxic activity in tumor cells by disrupting C/EBPβ-driven oncogenic activity. In its ongoing Phase 1-2 study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM, a durable RECIST 1.1-confirmed partial response in a patient with cutaneous melanoma and long-lasting stable disease in several additional patients. Alice Bexon, Sapience's Chief Medical Officer, commented, "We remain very pleased with ST101's clinical profile and we look forward to evaluating ST101 in the surgical sub-study announced today. The data generated from this study, if positive, will provide early safety and efficacy signs that would allow us to advance ST101 into a first-line therapeutic option for GBM, which would be transformative for this patient population." About ST101 and the Phase 1-2 Study 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, two-part, 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 novel peptide therapeutics for major unmet medical needs, particularly high mortality cancers. Sapience's approach holds potential to target intracellular interactions that are traditionally considered "undruggable targets". Its lead program, ST101, is a peptide 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.