On May 23, 2024 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, reported that clinical and biomarker data from its ST101 Phase 2 study in GBM will be delivered during an oral presentation on June 1, 2024 at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sapience Therapeutics, MAY 23, 2024, View Source [SID1234643637]).
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ST101 is a first-in-class antagonist of C/EBPβ, currently being evaluated in patients with recurrent and newly diagnosed GBM in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279).
Sapience’s Chief Medical Officer, Abi Vainstein-Haras, MD, stated, "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 (Free ASCO Whitepaper) 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, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center, and Principal Investigator of the ST101-101 clinical study added, "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."
Oral presentation details and abstract highlights 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 Type and Title: Clinical Science Symposium – Advancing Trial Design: Illuminating Tumor Evolution in Central Nervous System Cancer
Date and Time: 6/1/2024, 3:00 PM-4:30 PM CDT
Presenting Author: Fabio M. Iwamoto, MD, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center
ST101 has the potential to be a well-tolerated treatment option for patients with GBM
Outcome data to be presented from multiple cohorts of GBM patients
Main study: monotherapy in recurrent GBM
Window-of-Opportunity Study: mono/combination-therapy in GBM
Biomarker data to be presented from Window-of-Opportunity study cohorts
ST101 crosses the BBB and penetrates tumor tissue as shown by IHC
Target (C/EBPβ) engagement and degradation shown by IHC
Modulation of the tumor immune microenvironment to promote anti-tumor activity
Data supports continued clinical development of ST101 as a backbone treatment in combination with standard of care and immune-oncology agents.
The slide presentation described here will be made available on the Sapience Therapeutics website following the conference.
About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in patients with newly diagnosed and recurrent GBM (ndGBM and rGBM) in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279). In an ongoing window-of-opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in ndGBM, with patients receiving ST101 before and after surgical resection. ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and orphan designations for glioma from the U.S. FDA and the European Commission.