Iterion Therapeutics, a clinical-stage biopharmaceutical company, has been awarded a $7.1 million Product Development Research Grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the advancement of its lead candidate, tegavivint, into a Phase 2 clinical trial for patients with advanced hepatocellular carcinoma (HCC).
The grant (ID: DP260243), awarded on November 19, 2025, brings Iterion’s total non-dilutive funding from CPRIT to $26 million. The funding will support a Phase 1b/2 clinical study evaluating tegavivint, a first-in-class inhibitor targeting Transducin Beta-Like protein 1 (TBL1), a critical regulator of the Wnt/β-catenin signaling pathway.
Tegavivint represents a novel approach to addressing one of oncology’s most challenging targets. The Wnt/β-catenin pathway is implicated in tumor growth and resistance mechanisms across multiple cancers, including hepatocellular carcinoma, where approximately 40% of patients harbor activating mutations. Despite its clinical significance, the pathway has historically been considered “undruggable,” with no FDA-approved therapies currently available.
The ongoing clinical study will evaluate tegavivint both as a monotherapy and in combination with tyrosine kinase inhibitors (TKIs) in patients with advanced, unresectable HCC who have progressed following first-line treatment. Current standard-of-care therapies, including checkpoint inhibitor and anti-VEGF combinations, achieve an objective response rate of approximately 28%, while second-line TKIs demonstrate more limited efficacy, with response rates ranging from 4% to 10%. These outcomes highlight a substantial unmet need for more effective treatment options.
Tegavivint has already demonstrated promising safety, pharmacodynamic activity, and early signs of clinical efficacy in a completed Phase 1 trial in patients with progressive, unresectable desmoid tumors. Building on these results, the current study aims to further validate its therapeutic potential in HCC and generate data to inform the design of a future registrational trial.
The study is led by Principal Investigator Casey Cunningham and focuses on cancers of the liver, gallbladder, and intrahepatic bile duct. Iterion expects that findings from this trial will play a critical role in advancing tegavivint toward regulatory approval.
Iterion Therapeutics expressed its gratitude to CPRIT for its continued support, as well as to its investor syndicate, which includes Lumira Ventures, SANTÉ, Venture Investors Health Fund, Portal Innovations, Alexandria Real Estate Equities, Inc., and Green Park & Golf Ventures. Their ongoing backing has been instrumental in advancing the company’s mission to develop therapies targeting the Wnt pathway and improve outcomes for patients with advanced cancers.
Headquartered in Houston, Texas, Iterion Therapeutics remains focused on translating breakthrough science into meaningful clinical advances for patients facing limited treatment options.