Sapience Therapeutics Presents ST101 Clinical Data and ST316 Preclinical Data at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

TARRYTOWN, N.Y., Oct. 13, 2023 /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 the presentation of two posters at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023, in Boston, MA. 

Poster Presentation Details:

Title: "Clinical and Biological Activity of ST101, a Peptide Antagonist of C/EBPβ, in Recurrent Glioblastoma (rGBM) Patients. Results From the rGBM Cohort of a Multi-Cohort Phase 2 Study"
Poster Number: B038
Session Title: Poster Session B
Date/Time: Friday, October 13, 2023, 12:30 pm-4:00 pm
Session location: Level 2, Exhibit Hall D

• ST101 is a first-in-class antagonist of C/EBPβ that has demonstrated clinical proof-of-concept in advanced solid tumors. ST101 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).
• The poster summarized clinical data from ST101's recurrent Glioblastoma (rGBM) Phase 2 expansion cohort of 30 patients. The GBM cohort showed ≥ 1 response in the first 15 patients, triggering the criteria to expand to a total of 33 patients enrolled; 30 were evaluable for efficacy in this cohort.
• Key Conclusions:
  • ST101 demonstrates the ability to pass through the blood-brain-barrier and engage C/EBPβ.
  • Single agent ST101 demonstrated clinical activity and tissue treatment effect.
  • This data snapshot also demonstrated that patients receiving ST101 monotherapy exhibited encouraging response and survival outcomes.
  • Results from the ST101-101 study warrant further assessment of ST101 as part of a combination treatment approach for patients with rGBM.

Title: "Anti-tumor and Immunostimulatory Properties of ST316, a Peptide Antagonist of β-Catenin for Treatment of Cancers with Aberrant Wnt Pathway Activity"
Poster Number: B149
Session Title: Poster Session B
Date/Time: Friday, October 13, 2023, 12:30 pm-4:00 pm
Session location: Level 2, Exhibit Hall D

• ST316, a first-in-class antagonist of β-catenin, is designed to selectively target oncogenic activation of the Wnt/β-catenin signaling pathway without impacting its activity in normal cells. ST316 is currently being evaluated in the Phase 1 portion of a Phase 1-2 study, ST316-101 (NCT05848739), which is a limited solid tumor basket study for tumors likely to harbor abnormalities in the Wnt pathway, such as colorectal cancers.
• The poster summarized preclinical data demonstrating the anti-tumor and immunostimulatory properties of ST316 in multiple cancer models.
• Key Conclusions:
  • ST316 effectively inhibits the transcriptional activity of oncogenic β-catenin, resulting in reduction of Wnt target genes involved in carcinogenesis, cell division, cell migration and immunoinhibitory processes.
  • ST316 treatment results in reduced cell viability and tumor growth inhibition, marked by the reduced expression of Wnt target genes within tumor tissue.
  • ST316 induces polarization of hPBMC-derived M2 macrophages toward the M1 phenotype and enhances CD8+ T cell activation in mixed cultures of macrophages and T cells. Furthermore, subpharmacologic ST316 augments the efficacy of anti-PD-1 antibody in an orthotopic 4T1 TNBC tumor model.
  • These findings underscore ST316's potential as a therapeutic agent for targeting cancers characterized by aberrantly activated Wnt signaling pathways, showcasing its antitumor and immunostimulatory effects.

More information can be found on the AACR-NCI-EORTC 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 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 Stage IIb-IV melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

About ST316

ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex that drives 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.

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 Phase 1-2 study has begun enrolling and dosing patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. With its first patient dosed on June 5, 2023, the Company expects to complete the Phase 1 portion of the study in the second half of 2024. Following completion of the study's Phase 1 portion, the recommended dose will advance to the Phase 2 dose expansion portion of the study.

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. Sapience's in-house discovery platform enables the rational design of novel peptides with optimized properties for clinical development. Leveraging our 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. 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 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.

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.

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