Sapience Therapeutics to Present ST101 Phase 2 GBM Study Data at ASCO 2024

7 June 2024

TARRYTOWN, N.Y., May 23, 2024 — Sapience Therapeutics, Inc., a biotechnology firm specializing in peptide therapeutics for combating cancer, announced today that it will present clinical and biomarker data from its Phase 2 study of ST101 in glioblastoma multiforme (GBM) during an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2024.

ST101, an innovative first-in-class antagonist of the transcription factor C/EBPβ, is being tested in patients with both recurrent and newly diagnosed GBM as part of an ongoing Phase 1-2 clinical trial (NCT04478279). Sapience's Chief Medical Officer, Dr. Abi Vainstein-Haras, expressed optimism about the results, stating, "We are encouraged by ST101's clinical and biomarker data for patients with glioblastoma. This novel therapy has the potential to be a new treatment opportunity for this devastating disease, and we are honored to be presenting these promising results in an oral presentation at ASCO 2024. We are committed to bringing new hope to patients battling glioblastoma and look forward to advancing ST101 through clinical development."

Dr. Fabio M. Iwamoto, a principal investigator of the ST101-101 clinical study and part of the Division of Neuro-Oncology at New York-Presbyterian/Columbia University Irving Medical Center, echoed this sentiment. "Current treatments for recurrent glioblastoma offer limited hope for patients. I'm enthusiastic about the potential of ST101. It represents a novel approach with the potential to extend survival, both as a standalone therapy and in combination with existing treatments. Importantly, ST101's safety profile suggests it could be well-tolerated, potentially offering a significant benefit for patients battling this aggressive disease."

Key details of the oral presentation include:
- Abstract 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: Clinical Science Symposium – Advancing Trial Design: Illuminating Tumor Evolution in Central Nervous System Cancer
- Date and Time: June 1, 2024, 3:00 PM-4:30 PM CDT
- Presenter: Dr. Fabio M. Iwamoto

The presentation will outline the efficacy and biomarker data from multiple GBM patient cohorts treated with ST101, both as a monotherapy in recurrent GBM and in combination with radiation and temozolomide in newly diagnosed GBM. The data point to ST101's ability to cross the blood-brain barrier and engage and degrade its target, C/EBPβ, within tumor tissue, as evidenced by immunohistochemistry (IHC). This modulation of the tumor immune microenvironment suggests a potential for significant anti-tumor activity.

The findings support further clinical development of ST101, potentially in combination with standard of care and immune-oncology agents. Following the ASCO conference, the slide presentation will be available on the Sapience Therapeutics website.

About ST101

ST101, an innovative peptide therapy targeting C/EBPβ, is under evaluation in patients with newly diagnosed and recurrent GBM. In addition to the Phase 2 portion of the ongoing Phase 1-2 clinical study (NCT04478279), a window-of-opportunity sub-study is examining ST101 as both a monotherapy and in combination with other treatments. The U.S. FDA has granted ST101 Fast Track designation for recurrent GBM and orphan designations for glioma from both the U.S. FDA and the European Commission.

About Sapience Therapeutics

Sapience Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing peptide therapeutics to address cancer-related oncogenic and immune dysregulation. The company has developed a pipeline of therapeutic candidates, known as SPEARs™ and SPARCs, designed to disrupt traditionally undruggable intracellular protein interactions and deliver targeted payloads to cancer cells. Sapience is advancing its lead programs, ST316 and ST101, through Phase 1-2 clinical trials.

The presentation and data from the ongoing studies reflect the company's ongoing commitment to developing innovative treatments to improve outcomes for cancer patients.

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