Iterion Therapeutics Pioneers Novel Approach to Osteosarcoma with Tegavivint
HOUSTON, February 10, 2026 – Iterion Therapeutics, a clinical-stage biopharmaceutical company, has dosed the first patient in a clinical study evaluating tegavivint in combination with gemcitabine for relapsed or refractory osteosarcoma. This marks a significant step forward in addressing a rare pediatric cancer with limited treatment options.
Understanding Osteosarcoma and the Role of Wnt/β-catenin Signaling
Osteosarcoma, the most common malignant bone tumor in children and adolescents, often sees poor outcomes upon relapse. Recent research indicates a strong link between the Wnt/β-catenin signaling pathway and the progression of relapsed and metastatic osteosarcoma. Specifically, activation of this pathway is associated with tumor progression, treatment resistance and the spread of cancer.
Tegavivint: A First-in-Class Wnt/β-catenin Inhibitor
Tegavivint is a small-molecule inhibitor targeting TBL1, a crucial transcriptional co-factor for oncogenic β-catenin signaling. Unlike previous attempts to inhibit the Wnt pathway, tegavivint selectively disrupts the TBL1/β-catenin complex, promoting the degradation of nuclear β-catenin and suppressing tumor growth. This approach aims to avoid the toxicities that have plagued upstream Wnt inhibitors.
“Tegavivint represents a novel approach to targeting one of the central biological drivers of osteosarcoma,” stated Rahul Aras, PhD, President and CEO of Iterion Therapeutics.
Clinical Progress and FDA Designations
Tegavivint has already shown promising results in clinical trials for hepatocellular carcinoma and desmoid tumors, both cancers driven by aberrant Wnt/β-catenin signaling. A study led by the Children’s Oncology Group (COG) through the National Cancer Institute has established the safety of tegavivint in a broad pediatric population, paving the way for disease-focused combination studies like the current osteosarcoma trial.
The U.S. Food and Drug Administration (FDA) has granted tegavivint both Orphan Drug Designation and Pediatric Rare Disease Designation for the treatment of osteosarcoma, recognizing the unmet medical require in this area.
The Emory University Trial and Collaborative Support
The clinical trial is being sponsored by Emory University and conducted at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta. It’s supported by funding from the Peach Bowl LegACy Fund, demonstrating a strong commitment from academic, clinical, and philanthropic organizations to advance new therapies for pediatric cancer.
“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.”
Future Trends in Wnt/β-catenin Inhibition
Iterion Therapeutics’ work with tegavivint highlights a growing trend in cancer research: targeting downstream effects of signaling pathways rather than the pathways themselves. This approach can minimize off-target effects and improve tolerability, as demonstrated by tegavivint’s clinical profile.
The success of this trial could open doors for exploring tegavivint in other Wnt-driven cancers, including colorectal cancer (CRC), a market representing a multi-billion-dollar opportunity. Iterion is actively pursuing expansion opportunities in these areas.
Pro Tip:
Understanding the specific genetic mutations driving a cancer, like Wnt/β-catenin mutations in HCC and osteosarcoma, is crucial for personalized medicine and selecting the most effective therapies.
Frequently Asked Questions (FAQ)
Q: What is the Wnt/β-catenin pathway?
A: It’s a signaling pathway involved in cell growth and development. When it becomes abnormally active, it can contribute to cancer development.
Q: What makes tegavivint different from other Wnt inhibitors?
A: Tegavivint targets TBL1, a downstream component of the pathway, which avoids some of the toxicities seen with drugs targeting upstream components.
Q: What is Orphan Drug Designation?
A: It’s a designation from the FDA for drugs that treat rare diseases, offering incentives for development.
Q: What is the role of the Peach Bowl LegACy Fund?
A: The Peach Bowl LegACy Fund provides financial support for the clinical trial, demonstrating a commitment to pediatric cancer research.
Did you know? The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded Iterion Therapeutics $26 million in Product Development Awards, highlighting the potential of their Wnt/β-catenin inhibition platform.
Learn more about Iterion Therapeutics and their research at www.iteriontherapeutics.com.
Investor Contact: Laurence Watts, [email protected]
Media Contact: Ryan Walker, [email protected]
