Sapience Therapeutics Unveils Promising Data from Lucicebtide Phase 2 Trial at ASCO 2025

Sapience Therapeutics Reveals Positive Results from Lucicebtide Phase 2 Trial



At the recent 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Sapience Therapeutics, Inc. presented encouraging findings from its Phase 2 clinical trial of lucicebtide (previously known as ST101) targeting glioblastoma (GBM). This clinical-stage biotechnology company is committed to developing innovative peptide therapeutics for oncogenic and immune disorders driving cancer.

Dr. Fabio Iwamoto, a noted neuro-oncologist at New York-Presbyterian/Columbia University Irving Medical Center, emphasized the critical need for effective treatments for GBM, a particularly aggressive form of cancer with a dire prognosis and limited existing therapies. According to Dr. Iwamoto, the data from the ongoing Phase 2 study highlight lucicebtide's significant potential as an important addition to existing GBM treatment methods. The promise shown in both progression-free survival and overall survival rates suggests that this drug could potentially change the landscape of GBM management, offering hope for patients who currently have few options.

Dr. Abi Vainstein-Haras, Chief Medical Officer of Sapience, corroborated these insights, noting the positive safety profile of lucicebtide as both a standalone treatment and in conjunction with standard-of-care therapies. This clinical trial not only evaluated efficacy but also allowed for biomarker analyses, showcasing meaningful effects of the therapy on the tumor microenvironment.

Presentation Highlights


During the ASCO presentation, key results from the study were shared, revealing:

  • - Safety and Tolerability: Lucicebtide demonstrated a favorable safety profile as both a monotherapy and in combination with existing treatment regimens.

  • - Window-of-Opportunity Findings:
- In the newly diagnosed GBM cohort (n=9), as of May 6, 2025, five out of nine participants had not experienced disease progression (with durations ranging from 10 to 24+ months), and six patients remained alive (with survival times spanning 10 to 26+ months).
- In the recurrent GBM cohort (n=9), four patients exhibited disease control, including two partial responses, with three patients still alive by the data cutoff.

  • - Biomarker Insights: Notably, lucicebtide was able to cross the blood-brain barrier, engaging with tumor cells and promoting immune activity in the tumor microenvironment (TME). This was validated through increased macrophage M1/M2 ratios and CD8 T cell infiltration, alongside substantial reductions in mesenchymal gene signatures within tumor cells identified through spatial transcriptomics analysis.

These findings strongly indicate the therapeutic differentiation and promise that lucicebtide's action mechanism presents, particularly through the antagonism of C/EBPβ, in addressing treatment-resistant glioblastomas in patients.

Lucicebtide Overview


Lucicebtide, having garnered Fast Track designation from the U.S. Food and Drug Administration (FDA) for recurrent glioblastoma (rGBM), is undergoing further investigation in a Window-of-Opportunity study, which evaluates its efficacy in combination with radiation and temozolomide for newly diagnosed GBM patients, as well as assessing its application as a monotherapy in the recurrent setting.

Sapience Therapeutics maintains a steadfast focus on pioneering peptide-based therapies, leveraging innovative candidates like lucicebtide and ST316, a β-catenin antagonist, to explore new avenues in treating complex oncological conditions.

For further information, visit Sapience Therapeutics and follow their updates on LinkedIn.

Topics Health)

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