On February 10, 2026 Iterion Therapeutics, a clinical-stage, biopharmaceutical company dedicated to revolutionizing the treatment of Wnt-driven cancers, reported that the first patient has been dosed in a clinical study evaluating tegavivint, a first-in-class inhibitor of the Wnt/β-catenin pathway, in combination with gemcitabine for patients with relapsed or refractory osteosarcoma. The trial is sponsored by Emory University, conducted at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta and supported by funding from the Peach Bowl LegACy Fund, reflecting strong academic, clinical and philanthropic commitment to advancing new therapies for this rare pediatric cancer.
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Osteosarcoma is the most common malignant bone tumor in children and adolescents, and outcomes following relapse remain poor. A growing body of research has shown that Wnt/β-catenin signaling is highly active in relapsed and metastatic osteosarcoma, where it is associated with tumor progression, treatment resistance, and metastasis.
Tegavivint is a small-molecule inhibitor of TBL1, a transcriptional co-factor required for oncogenic β-catenin signaling. By selectively disrupting the TBL1/β-catenin transcriptional complex, tegavivint promotes degradation of nuclear β-catenin and suppresses β-catenin-dependent gene transcription, shutting down Wnt-driven tumor growth while avoiding the dose-limiting toxicities historically associated with upstream Wnt inhibition.
"Tegavivint represents a novel approach to targeting one of the central biological drivers of osteosarcoma," said Rahul Aras, PhD, President and CEO of Iterion Therapeutics. "This first patient dosed marks an important clinical milestone for a program supported by extensive biological validation and reinforces the broader value of our Wnt/β-catenin platform."
Tegavivint has already demonstrated favorable tolerability, pharmacodynamic activity, and encouraging monotherapy clinical responses in Company-sponsored clinical trials in hepatocellular carcinoma and desmoid tumors, two diseases driven by aberrant Wnt/β-catenin signaling. In addition, a Children’s Oncology Group (COG)-led study conducted through the National Cancer Institute has established the safety of tegavivint across a broad pediatric population, providing a strong foundation for advancement into disease-focused combination studies in osteosarcoma.
"Tegavivint is uniquely positioned for osteosarcoma because it targets a pathway that is consistently active in high-risk and relapsed disease," said Thomas Cash, MD, Principal Investigator of the study at the Aflac Cancer and Blood Disorders Center and Associate Professor of Pediatrics at Emory University. "Evaluating tegavivint in combination with gemcitabine allows us to build on a strong scientific foundation as we seek to improve outcomes for patients with limited treatment options."
Tegavivint has received both Orphan Drug Designation and Pediatric Rare Disease Designation from the U.S. Food and Drug Administration for the treatment of osteosarcoma.
(Press release, Iterion Therapeutics, FEB 10, 2026, View Source [SID1234662569])