ST316

ST316 is a first-in-class peptide therapeutic that acts as an antagonist of β-catenin and its co-activator BCL9. It is designed to selectively inhibit the Wnt/β-catenin signaling pathway by disrupting the interaction between β-catenin and BCL9, which drives oncogene expression and immune exclusion in cancers with aberrant Wnt/β-catenin activity. By preventing BCL9-driven nuclear localization of β-catenin and inhibiting formation of the Wnt enhanceosome protein complex, ST316 suppresses transcription of oncogenic Wnt target genes involved in tumor proliferation, migration, invasion, metastasis, and immunosuppression. This mechanism creates a pro-immune tumor microenvironment. Preclinical models have shown synergy with checkpoint inhibitors. The drug is being developed for colorectal cancer (CRC) and has received FDA Orphan Drug Designation for familial adenomatous polyposis (FAP). Clinical trials are ongoing in advanced solid tumors known to harbor abnormalities in the Wnt/β-catenin pathway[2][3][5][6][7].