On November 17, 2023 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 the presentation of new Phase 2 clinical data for ST101 at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting 2023 (Press release, Sapience Therapeutics, NOV 17, 2023, View Source [SID1234637780]). The poster summarized results from an ongoing surgical window of opportunity sub-study in newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM) patients.

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Poster Presentation Details and Summary of Data:

Title: "Neoadjuvant treatment with monotherapy ST101, a C/EBPβ antagonist, results in pathological and clinical responses in glioblastoma patients. Tissue-based analysis and clinical outcomes from a surgical window of opportunity clinical trial."
Poster Number: CTNI-44
Date and Time: Friday, November 17, 2023, 7:30 pm – 9:30 pm PT
Presenter: Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center

The SNO poster summarized data from an ongoing surgical window of opportunity sub-study designed to assess the effect of neoadjuvant and adjuvant treatment with ST101 on tumor tissue and clinical outcomes, as well as assessment of biomarkers in tumors and blood.
In the sub-study, patients receive 2-4 doses of IV 500 mg ST101 QW neoadjuvant.
Following surgery, ndGBM patients continue ST101 QW + temozolomide (TMZ) + radiation; rGBM patients continue ST101 as monotherapy.
MRI assessment is conducted at screening, post ST101 neoadjuvant and before surgery, after surgery, and every 9 weeks thereafter.
As of November 7, 2023, 12 patients received 2-4 doses of ST101 before surgery and were evaluable (6 with ndGBM and 6 with rGBM).
Key Results as of November 7, 2023:

Newly diagnosed GBM:
83% Disease Control Rate (DCR), including 1 Complete Response (CR) and 4 patients with Stable Disease (SD), in 6 patients treated with neoadjuvant and adjuvant ST101 as part of their standard of care treatment.
5/6 patients remain on study, with a treatment duration of ~15-38 weeks.
Recurrent GBM:
67% DCR, including 2 Partial Responses (PRs) and 2 SD, in 6 patients treated with neoadjuvant and adjuvant ST101 monotherapy.
3/6 patients remain on study with disease control beyond 6 months (2 PR and 1 SD), resulting in a 6-month PFS of 50%.
Extensive treatment-related effects (geographical necrotic tissue) were observed in GBM patients treated with neoadjuvant ST101 monotherapy, including patients who were previously treatment-naïve.
"The results demonstrated with ST101 in this GBM study are very encouraging, given the poor prognosis associated with this devastating brain cancer. Based on the results thus far, administration of ST101, before and/or after brain surgery, has a direct impact on GBM cells and a favorable effect on the tumor microenvironment, which translates to longer disease control and potential partial or complete responses to therapy," said Dr. Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center. "I look forward to continuing to evaluate ST101 in the ongoing Phase 2 study and delivering hope to my GBM patients and their families."

More information can be found on the 2023 SNO website.

About ST101

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing Phase 2 dose expansion rGBM cohort (n=30), ST101 weekly administration resulted in a 30% Disease Control Rate (DCR) with 1 Partial Response (PR) and 8 patients with Stable Disease (SD), with a 6-month median duration of SD. In the ongoing surgical window of opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in newly diagnosed GBM (ndGBM).

ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and Orphan Drug designations for glioma from the U.S. FDA and the European Commission.