Sapience Therapeutics Provides Data Update from Phase 2 Trial of Lucicebtide in Patients with Glioblastoma at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

-Clinical benefit and favorable safety profile as monotherapy and in combination with SOC-

-Biomarker data supports MOA: decreased GBM mesenchymal signature and increased TME immune activity-

TARRYTOWN, N.Y., June 2, 2025 /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 updated positive clinical and biomarker data from its Phase 2 clinical trial of lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, in patients with glioblastoma (GBM). The data were featured during an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3, 2025, in Chicago and online.

"GBM represents a devastating disease carrying a poor prognosis and high mortality rate, and there is a significant need for new, efficacious treatment options," said Fabio Iwamoto, MD, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center. "The growing body of data from this Phase 2 study, which demonstrate a marked progression free and overall survival benefit, continue to support that lucicebtide could serve as a well-tolerated, meaningful addition to the GBM treatment paradigm. I look forward to deepening our understanding of the potential for lucicebtide to improve outcomes and offer hope to patients for whom limited alternatives exist."

Sapience Chief Medical Officer, Dr. Abi Vainstein-Haras, added, "These updated results reinforce lucicebtide's compelling clinical and safety profile, and support its potential to serve as a standalone therapy or in combination with existing treatments. The opportunity to collect biopsies in this patient population gave us a unique opportunity for biomarker analysis to demonstrate the meaningful effects of lucicebtide."  

Oral Presentation Highlights Include:

• Lucicebtide was well-tolerated as a monotherapy and in combination with standard-of-care (SOC) agents.
• Lucicebtide combination with SOC Window-of-Opportunity study in newly diagnosed GBM cohort (n=9), data cut May 6, 2025:
  • 5/9 patients yet to experience disease progression (10-24+ months)
  • 6/9 patients are alive as of the data cutoff date (10-26+ months)
• Lucicebtide Window-of-Opportunity study in recurrent GBM cohort (n=9), data cut May 6, 2025:
  • 4/9 patients had disease control, with two partial responses
  • 3/9 patients remain alive as of data cutoff
• Window-of-Opportunity biomarker results demonstrate:
  • Lucicebtide crossed the blood-brain barrier, demonstrated uptake into the tumor and target engagement
  • Immune activation in the tumor microenvironment (TME) evidenced by increased macrophage M1/M2 ratio and CD8 T cell infiltration
  • Meaningful reductions in mesenchymal gene signature in tumor cells as shown by spacial transcriptomics analysis
• Data support lucicebtide and C/EBPβ antagonism as a differentiated and promising therapeutic approach for patients with GBM.

A copy of the presentation is available under the Presentations section of the Sapience Therapeutics website.

About Lucicebtide (formerly known as ST101)

Lucicebtide, a first-in-class antagonist of C/EBPβ, has completed the main portion of a Phase 2 dose expansion study in recurrent glioblastoma (rGBM) (NCT04478279). An ongoing Window-of-Opportunity sub-study is evaluating lucicebtide in combination with radiation and temozolomide in patients with newly diagnosed GBM (ndGBM) and as a monotherapy in patients with rGBM, with patients receiving lucicebtide before and after surgical resection in both cohorts. Lucicebtide has been granted Fast Track designation for rGBM from the U.S. Food and Drug Administration (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. Sapience can also direct cargo to cell surface targets with their new class of molecule called SPARCs™ (Stabilized Peptides Against Receptors on Cancer), enabling delivery of radioisotope payloads such as α-particles to cancer cells. Sapience is advancing its lead programs, lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, and ST316, a first-in-class antagonist of β-catenin, through Phase 2 clinical trials.

For more information on Sapience Therapeutics, please visit https://sapiencetherapeutics.com/ and engage with us on LinkedIn.

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