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Sapience Therapeutics Unveils ST316 Phase 1 Results at ASCO 2025

On January 27, 2025, Sapience Therapeutics, a clinical-stage biotech firm, shared their groundbreaking Phase 1 clinical findings on ST316 at the prestigious American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. This promising peptide antagonist targets β-catenin and aims to tackle oncogenic signaling pathways that contribute to tumor development.

The Significance of ST316

ST316 represents a pioneering approach in cancer therapy, acting as a first-in-class antagonist to inhibit the interaction between β-catenin and its co-activator, BCL9. This inhibition is crucial for shutting down the Wnt/β-catenin signaling pathway, which plays a significant role in various cancers. The Phase 1 dose escalation trial evaluated the safety and initial efficacy of ST316 in patients with advanced solid tumors, making strides towards its potential use in colorectal cancer (CRC).

Dr. Abi Vainstein-Haras, the Chief Medical Officer at Sapience, expressed satisfaction with the trial results, stating, "We are pleased that the ST316 Phase 1 Dose Escalation study demonstrated clinical proof-of-concept as a single agent, in a patient population in which single agent response is limited." The findings revealed preliminary signs of anti-tumor activity and a clean safety profile, paving the way for further development in ongoing trials.

Key Phase 1 Results

The clinical study results indicate:

• - ST316 successfully inhibits β-catenin and BCL9 interactions, leading to effective Wnt/β-catenin pathway inhibition.
• - Throughout all dose groups assessed, ST316 was well tolerated, reinforcing its safety.
• - Notably, patients exhibited prolonged stable disease, consistent with encouraging anti-tumor activity.
• - In terms of pharmacodynamics, the treatment resulted in shifts of β-catenin from the nucleus to the cytoplasm/membrane in a majority of assessed patients, indicating target engagement.
• - ST316 significantly reduced levels of immunosuppressive PMN-MDSCs in patients with elevated baseline levels.

Encouragingly, these results led to ST316 being tested in combination with chemotherapy for advanced CRC patients, demonstrating its potential as part of a comprehensive treatment strategy.

ASCO Presentation Highlights

The presentation titled, "Safety and biomarker assessment of ST316, a novel peptide antagonist of β-catenin, in patients with advanced solid tumors," was made on January 25, 2025, during a dedicated poster session. Dr. Anthony El-Khoueiry led this session, attracting considerable interest from medical professionals and researchers.

Understanding ST316's Mechanism

ST316 functions by preventing the nuclear localization of β-catenin within cancer cells and obstructing the formation of the Wnt enhanceosome complex, which is essential for expressing oncogenes. This mechanism is particularly significant in cancers exhibiting aberrant Wnt/β-catenin signaling. By modifying this signaling pathway, ST316 aims to create a more favorable immune environment against the tumor, promoting a synergistic effect when combined with checkpoint inhibitors in preclinical studies.

Future Prospects

The clinical trial (ST316-101) is continuing through a Phase 2 study, evaluating ST316's safety, pharmacokinetics, and efficacy in combination therapies across multiple treatment lines for CRC. Additionally, the U.S. FDA has granted Orphan Drug Designation to ST316 for treating familial adenomatous polyposis, indicating its potential significance in treating rare cancers.

About Sapience Therapeutics: The company continues to innovate in peptide therapeutics, focusing on addressing oncogenic properties and immune dysregulation in cancer therapy. With its proprietary technologies, Sapience aims to develop safer and more effective cancer treatments while navigating challenges associated with previously established therapeutic routes.

To explore further details about Sapience Therapeutics and their groundbreaking research, please visit their official website or engage with them on LinkedIn.