On June 1, 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 new clinical and biomarker data from its ST101 Phase 2 study in GBM at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sapience Therapeutics, JUN 1, 2024, View Source [SID1234643953]). 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).

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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, said, "ST101’s clinical activity in GBM patients in the expansion and window-of-opportunity studies is highly encouraging, showing durable responses, a compelling survival benefit, and remodeling of the tumor microenvironment to an immune-active state. I am pleased to present this data at ASCO (Free ASCO Whitepaper) and look forward to ST101 advancing into Phase 2b combination studies."

Dr. Abi Vainstein-Haras, Sapience’s Chief Medical Officer, added, "ST101’s impressive clinical results and favorable safety profile add to the growing body of data supporting C/EBPβ as a promising target for the treatment of GBM. Our biomarker results demonstrate a clear impact on the tumor microenvironment, providing rationale to explore ST101 in combination with immune-oncology agents, such as checkpoint inhibitors. We look forward to advancing a comprehensive clinical development program for ST101 with the goal of extending survival and improving outcomes for patients with this devastating disease."

Oral presentation highlights include:

Presentation 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 presented from multiple cohorts of GBM patients (n=42)
Main study: monotherapy in recurrent GBM, n=30
2 patients with PRs, on study treatment for 55 weeks and 59+ weeks
7 patients with SD with on study treatment for a range of 13-79 weeks
53% OS and 40% OS at 9 and 12 months, respectively
Window-of-Opportunity Study: ST101 monotherapy in recurrent GBM, n=6
2 PRs (1 unconfirmed), 1 ongoing
2 SD, 1 ongoing
Median OS ~12 months; 3/6 patients alive (41-62 wks)
Window-of-Opportunity Study: combination of ST101 with standard-of-care (radiation and temozolomide) in newly diagnosed GBM, n=6
1 CR, duration ~1 year and ongoing
4 SD, 3 ongoing
5/6 patients alive (25-57 wks)
Biomarker data 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
The slide presentation is available under the Presentations tab on the Sapience Therapeutics website.

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.