Sapience Therapeutics announced that Phase 2 clinical trial data for lucicebtide (formerly ST101), a first-in-class antagonist of C/EBPβ, in glioblastoma patients will be featured in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation, scheduled for Saturday, May 31, 2025, from 3:00 pm to 4:30 pm CDT, will be delivered by Dr. Fabio M. Iwamoto from the Division of Neuro-Oncology at New York-Presbyterian/Columbia University Irving Medical Center.
Phase 2 Trial Results and Mechanism of Action
The presentation, titled "Use of lucicebtide (ST101) in glioblastoma patients by antagonism of C/EBPβ-dependent mesenchymal cell transition and immunosuppressive M2 macrophage polarization," will detail how the drug targets specific cellular processes in glioblastoma. Lucicebtide works by antagonizing C/EBPβ-dependent mesenchymal cell transition and immunosuppressive M2 macrophage polarization, representing a novel therapeutic approach for this aggressive brain cancer.
The company has completed the main portion of a Phase 2 dose expansion study in recurrent glioblastoma (rGBM) under clinical trial identifier NCT04478279. This study represents a significant milestone for the first-in-class C/EBPβ antagonist, which targets transcription factors traditionally considered undruggable.
Ongoing Clinical Development
An ongoing window-of-opportunity sub-study is currently evaluating lucicebtide in two distinct patient populations. The study is testing lucicebtide in combination with radiation and temozolomide in patients with newly diagnosed glioblastoma (ndGBM) and as a monotherapy in patients with recurrent glioblastoma. In both cohorts, patients receive ST101 before and after surgical resection, allowing researchers to assess the drug's impact on tumor biology.
Regulatory Recognition
Lucicebtide has received significant regulatory recognition for its potential in treating glioblastoma. The U.S. Food and Drug Administration has granted the drug Fast Track designation for recurrent glioblastoma, a status reserved for therapies addressing unmet medical needs in serious conditions. Additionally, lucicebtide has received orphan designations for glioma from both the U.S. FDA and the European Commission, highlighting the drug's potential to address this rare and devastating disease.
Company's Therapeutic Platform
Sapience Therapeutics has developed a proprietary platform of therapeutic candidates called SPEARs™ (Stabilized Peptides Engineered Against Regulation) that disrupt intracellular protein-protein interactions. This technology enables targeting of transcription factors which have traditionally been considered undruggable. The company has also developed SPARCs™ (Stabilized Peptides Against Receptors on Cancer), a new class of molecules that can direct cargo to cell surface targets, enabling delivery of radioisotope payloads such as α-particles to cancer cells.
Beyond lucicebtide, Sapience is advancing ST316, a first-in-class antagonist of β-catenin, through Phase 2 clinical trials. The clinical-stage biotechnology company focuses on discovering and developing peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, with in-house discovery capabilities supporting its pipeline development.
