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Grant Information

Grant ID	DP260243
Awarded On	November 19, 2025
Title	Phase 1b/2 Clinical Trial of the First-in-Class TBL1 Inhibitor (Tegavivint) for the Treatment of Patients with Advanced, Unresectable Hepatocellular Carcinoma
Program	Product Development Research
Award Mechanism	Texas Therapeutics Company Awards for Product Development Research
Institution/Organization	Iterion Therapeutics Inc.
Principal Investigator/Program Director	Casey Cunningham
Cancer Sites	Gallbladder, Liver and Intrahepatic Bile Duct
Contracted Amount	$7125242
Lay Summary	Iterion Therapeutics is a clinical stage biopharmaceutical company in Houston, TX. The company’s lead asset, tegavivint, is a potent, first-in-class inhibitor of Transducin Beta-Like protein 1 (TBL1), a downstream target for inhibiting the canonical Wnt/beta-catenin pathway. Tegavivint is being evaluated in an ongoing Phase 1b/2 clinical study in patients with advanced hepatocellular carcinoma after exhibiting safety, pharmacodynamic and clinical activity in a completed Phase 1 trial in progressive, unresectable desmoid tumors. Approximately 40% of HCC patients have a beta-catenin activating mutation and both TBL1 and beta-catenin serve as markers for poor prognosis. HCC is the 3rd leading ... Read More Iterion Therapeutics is a clinical stage biopharmaceutical company in Houston, TX. The company’s lead asset, tegavivint, is a potent, first-in-class inhibitor of Transducin Beta-Like protein 1 (TBL1), a downstream target for inhibiting the canonical Wnt/beta-catenin pathway. Tegavivint is being evaluated in an ongoing Phase 1b/2 clinical study in patients with advanced hepatocellular carcinoma after exhibiting safety, pharmacodynamic and clinical activity in a completed Phase 1 trial in progressive, unresectable desmoid tumors. Approximately 40% of HCC patients have a beta-catenin activating mutation and both TBL1 and beta-catenin serve as markers for poor prognosis. HCC is the 3rd leading cause of cancer death worldwide. Approved 1L systemic therapy involves combination of a checkpoint inhibitor and anti-VEGF therapy and demonstrates only a 28% ORR. Agents such as tyrosine-kinase inhibitors (TKIs) commonly used in 2L demonstrate ORR in the 4-10% range, leaving a significant unmet clinical need. Despite the high prevalence of HCC patients with Wnt/beta-catenin signaling activation and their poor prognosis, there are no FDA-approved treatments targeting the Wnt pathway. Iterion seeks funding for an ongoing clinical trial of tegavivint with or without a TKI, in patients with beta-catenin activating mutations that have failed 1L therapy. Data from this study will guide design of a registrational study supporting tegavivint approval in advanced HCC. Read Less