Sapience Therapeutics Presents Positive Clinical and Biomarker Data from ST101 Phase 2 Study in GBM at ASCO 2024 in Oral Presentation

-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 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.

Media and Investor Contact:
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SOURCE Sapience Therapeutics, Inc.