TARRYTOWN, N.Y., Nov. 9, 2024
-ST101 Phase 2 data demonstrates activation of the tumor immune microenvironment in glioblastoma (GBM)-
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-ST316 Phase 1 data demonstrates antagonism of ß-catenin-driven immune exclusion-
TARRYTOWN, N.Y., Nov. 9, 2024 /PRNewswire/ -- 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, today announced the presentation of clinical and non-clinical results on its lead programs, ST101 and ST316, at the Society for Immunotherapy of Cancer's (SITC) 39th Annual Meeting, being held November 6-10, 2024, in Houston, TX.
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ST101 is a first-in-class antagonist of C/EBPß, currently being evaluated in patients with recurrent and newly diagnosed GBM in the Phase 2 portion of a Phase 1-2 clinical study (NCT04478279). ST316 is a first-in-class antagonist of the interaction between ß-catenin and its co-activator, BCL9, a complex responsible for driving oncogene expression in multiple cancers where aberrant Wnt/ß-catenin pathway signaling is observed and immune-exclusion in the tumor microenvironment. ST316 is being evaluated in colorectal cancer patients in the Phase 2 portion of a Phase 1-2 study (NCT05848739).
Dr. Jim Rotolo, Sapience's SVP, Research and Translational Sciences, commented, "I am thrilled to have presented new clinical and biomarker data on ST101, which provides further evidence that C/EBPß is a multi-faceted target for the treatment of newly diagnosed and recurrent GBM. The inclusion of our presentation in SITC's press briefing earlier this week, as one of 8 abstracts of the more than 1,500 received, highlights the novelty and importance of the data we are observing in our clinical study. Through our Phase 2 and Window-of-Opportunity studies, ST101 has demonstrated impressive disease control as well as modulation of the tumor immune microenvironment (TIME) from immunosuppressive to immune-active. This TIME shift is highly compelling given the immunosuppressive environment that is known to limit the efficacy of immune-oncology (I/O) agents in the treatment of GBM."
Dr. Rotolo continued, "We also presented initial clinical pharmacodynamic data from our ST316 Phase 1 study, demonstrating that ST316 dramatically depletes immunosuppressive cells from peripheral blood of patients. In non-clinical studies, we were pleased to see that treatment with ST316 and PD-1 checkpoint inhibitors had positive effects on tumor outcomes and immune activation. These results at SITC, coupled with the data we have from the Phase 1 study, provide further validation that ST316 has the potential to improve existing I/O approaches."
ST101 Oral Presentation Highlights Include:
Title: "ST101, an inhibitor of the transcription factor C/EBPß, promotes an immune-active tumor microenvironment in a window of opportunity (WoO) study of patients with glioblastoma (GBM)"Abstract #: 991Session Title: Biotech Breakthroughs – Solid Tumor IO at the Tipping PointDate/Time: Friday, November 8, 2024, 1:45 pm – 3:20 pm CSTSession Location: George R. Brown Convention Center, Level 3 – Grand Ballroom BPresenting Author: Jim Rotolo, Ph.D., SVP, Research & Translational Sciences, Sapience Therapeutics
ST101 Poster:
Title: "ST101, an inhibitor of the transcription factor C/EBPß, promotes an immune-active tumor microenvironment in a window of opportunity (WoO) study of patients with glioblastoma (GBM)"Abstract #: 991Session: Poster HallDate/Time:
Session Location: George R. Brown Convention Center, Level 1 – Exhibit Halls AB
ST316 Poster Presentation Details:
Title: "ST316, a peptide antagonist of ß-Catenin, depletes immunosuppressive myeloid cell populations and enhances anti-cancer immune responses in in vivo tumor models and in patients"Abstract #: 1451Session: Poster HallDate/Time:
Session Location: George R. Brown Convention Center, Level 1 – Exhibit Halls ABPresenting Author: Claudio Scuoppo, Ph.D., Principal Scientist, Sapience Therapeutics
About ST101ST101, a first-in-class antagonist of C/EBPß, has completed the main portion of a Phase 2 dose expansion study in recurrent GBM (rGBM) (NCT04478279). An ongoing window-of-opportunity sub-study is evaluating ST101 as a monotherapy in patients with rGBM and in combination with radiation and temozolomide in patients with newly diagnosed GBM (ndGBM), with patients receiving ST101 before and after surgical resection in both cohorts. 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.
About ST316ST316 is a first-in-class peptide antagonist of the interaction between ß-catenin and its co-activator, BCL9, a complex responsible for driving oncogene expression in multiple cancers where aberrant Wnt/ß-catenin pathway signaling is observed. ST316 is being evaluated in the Phase 2 portion of a Phase 1-2 dose-escalation and expansion study (NCT05848739). The Phase 1 portion completed enrollment in July 2024. In the Phase 2 dose expansion, ST316 is being tested in colorectal cancer patients in combination with relevant standards of care and in multiple lines of treatment. Sapience is conducting the Phase 2 study across several sites in the United States.
About Sapience TherapeuticsSapience Therapeutics, Inc. is a privately held, clinical-stage biotechnology company focused on discovering and developing peptide therapeutics to address oncogenic and immune dysregulation that drive cancer. With in-house discovery capabilities, Sapience has built a pipeline of therapeutic candidates called SPEARs™ (Stabilized Peptides Engineered Against Regulation) that disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable, and can direct cargo to cell surface targets with their new class of molecule called SPARCs™ (Stabilized Peptides Against Receptors on Cancer), enabling delivery of payloads such as a-particles to cancer cells. Sapience is advancing its lead programs, ST316, a first-in-class antagonist of ß-catenin, and ST101, a first-in-class antagonist of C/EBPß, through Phase 2 clinical trials.
For more information on Sapience Therapeutics, please visit https://sapiencetherapeutics.com/ and engage with us on LinkedIn.
Media and Investor Contact:Amy ConradJuniper Point(858) [email protected]
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