Long-term follow-up reinforces PFS and OS benefit of lucicebtide plus standard of care in ndGBM: mPFS projected at 28.4 months, mOS not yet reached with 6 of 9 patients alive

TARRYTOWN, N.Y., May 21, 2026 /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 pharmacodynamic data from its Phase 2 clinical trial of lucicebtide, a first-in-class antagonist of C/EBPβ, alone or in combination with chemoradiation standard-of-care (SOC) in patients with glioblastoma (GBM) at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2, 2026, in Chicago and online.

Despite being the most common and lethal malignant brain tumor, with more than 14,000 patients diagnosed each year in the United States, GBM remains an underserved disease, with limited progress in overall survival for patients over the last 20 years.¹ C/EBPβ drives tumor growth and survival, and is a master regulator of the mesenchymal transformation in GBM, a state associated with chemotherapy resistance and aggressive disease, supporting it as a compelling therapeutic target for GBM. C/EBPβ is also recognized as regulating an immune-suppressive program in tumor-associated macrophages that contributes to tumor growth and progression. ^2,3

Sapience's ongoing Phase 2 Window-of-Opportunity study is evaluating lucicebtide alone or in combination with SOC in patients with GBM, with dosing administered before and after surgical resection. Nine patients are evaluable for analysis. As of April 27, 2026:

• Patients with ndGBM treated with lucicebtide in combination with SOC achieved PFS and OS outcomes that exceed those reported in the published literature
  • Projected mPFS of 28.4 months meaningfully exceeds the 4.0 to 6.9-month historic benchmark range ^4,5
  • mOS not yet reached; 6 of 9 patients remain alive beyond 22.3 months (per the cutoff date), exceeding the 14.6 to 17.0-month historic benchmark range ^4,6
• Lucicebtide activity is further demonstrated by on-target clinical pharmacodynamics
  • Target engagement confirmed via negative enrichment of C/EBPβ regulon in tumor and myeloid cells
  • Suppression of the mesenchymal GBM transformation observed by spatial transcriptomics analysis
• Lucicebtide is well tolerated, with no DLTs or related SAEs observed

"The ASCO 2026 lucicebtide dataset continues to reinforce our conviction in the strength of this program," said Barry Kappel, Ph.D., Sapience's Chief Executive Officer. "The maturing results show durable progression free and overall survival improvements, and clearly position lucicebtide as a promising, well‑tolerated therapy with the potential to elevate the standard of care in GBM. We are eager to advance this program to bring meaningful progress to patients and families affected by this devastating disease."

Details of the presentation are as follows:

Title: "Lucicebtide (ST101) Plus Chemoradiation in Newly Diagnosed GBM Patients: Efficacy, Pharmacodynamics, and Safety in Phase 2 Window-of-Opportunity Study"
Session Title: Poster Session - Central Nervous System Tumors
Poster Board: 444
Date and Time: Monday, June 1, 2026, 1:30 PM-4:30 PM CDT

More information can be found on the ASCO Annual Meeting 2026 website.

About Lucicebtide (formerly known as ST101)
Lucicebtide is a first-in-class peptide antagonist of CCAAT/enhancer-binding protein β (C/EBPβ), a transcription factor that drives tumor aggressiveness, immune evasion and therapy resistance in GBM. Lucicebtide has been studied in 125 patients and is observed to be safe, well-tolerated and clinically active both as a monotherapy in recurrent GBM (rGBM) and in combination with SOC chemoradiation in ndGBM. Lucicebtide was designed with a cell-penetration domain that enables it to cross the blood-brain barrier and enter the nucleus of cells, and a binding domain that specifically interacts with C/EBPβ, preventing it from dimerizing to an active state and driving it to be degraded by the cell's own machinery.⁷ 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 the Lucicebtide Window-of-Opportunity Study
Lucicebtide has completed the main portion of a Phase 2 dose expansion study in 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.

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, ST316, a first-in-class antagonist of β-catenin, and lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, through Phase 2 clinical trials.

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

¹ Dhingra S, Koshy M, Korpics M. Limited survival benefit in patients diagnosed with glioblastoma post-2016: a SEER population based registry analysis. J Cancer Res Clin Oncol. 2025 Jun 2;151(6):179. doi: 10.1007/s00432-025-06171-4. PMID: 40455099; PMCID: PMC12130152
² Kudo T, Prentzell MT, Mohapatra SR, Sahm F, Zhao Z, Grummt I, Wick W, Opitz CA, Platten M and Green EW (2020) Constitutive Expression of the Immunosuppressive Tryptophan Dioxygenase TDO2 in Glioblastoma Is Driven by the Transcription Factor C/EBPβ. Front. Immunol. 11:657. doi: 10.3389/fimmu.2020.00657
³ Yang Y, Jin X, Xie Y, Ning C, Ai Y, Wei H, Xu X, Ge X, Yi T, Huang Q, Yang X, Jiang T, Wang X, Piao Y, Jin X. The CEBPB+ glioblastoma subcluster specifically drives the formation of M2 tumor-associated macrophages to promote malignancy growth. Theranostics. 2024 Jul 2;14(10):4107-4126. doi: 10.7150/thno.93473. PMID: 38994023; PMCID: PMC11234274.
⁴ Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med, 2005. DOI: 10.1056/NEJMoa043330.PMID: 15758009
⁵ Stupp R, Taillibert S, Kanner A, et al. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017;318(23):2306–2316. doi:10.1001/jama.2017.18718
⁶ Roth, P., et al., Marizomib for patients with newly diagnosed glioblastoma: A randomized phase 3 trial, Neuro-Oncology, Volume 26, Issue 9, September 2024, Pages 1670–1682, https://doi.org/10.1093/neuonc/noae053
⁷ Darvishi E, Ghamsari L, Leong SF, Ramirez R, Koester M, Gallagher E, Yu M, Mason JM, Merutka G, Kappel BJ, Rotolo JA. Anticancer Activity of ST101, A Novel Antagonist of CCAAT/Enhancer Binding Protein β. Mol Cancer Ther. 2022 Nov 3;21(11):1632-1644. doi: 10.1158/1535-7163.MCT-21-0962. PMID: 36121385; PMCID: PMC9630826.

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