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Iterion Therapeutics Initiates Phase 1b/2a Clinical Trial for Tegavivint in Advanced Hepatocellular Carcinoma Patients who have Previously Received Systemic Treatments

Tuesday, February 20, 2024

Iterion Therapeutics, a biopharmaceutical company specializing in oncology, has announced the active enrollment of a Phase 1b/2a clinical trial for its lead compound, tegavivint, targeting patients with advanced hepatocellular carcinoma (HCC) who have previously failed systemic therapy.

The Wnt/beta-catenin signaling pathway is implicated in various cancers, including HCC, where a significant portion of patients exhibit Wnt-activating mutations. Conventional drug development targeting key pathway members like beta-catenin has faced challenges due to resistance and off-target toxicities. Preclinical studies suggest that Transducin beta-like protein 1 (TBL1) is a downstream target essential for Wnt/beta-catenin-driven oncogenesis. Tegavivint disrupts the interaction between TBL1 and nuclear beta-catenin, thereby preventing the transcription of cancer-causing genes associated with oncogenic activity.

Iterion Therapeutics, emphasized tegavivint's ability to inhibit nuclear beta-catenin oncogenic activity without the toxicities associated with upstream drugs in the Wnt pathway. With HCC being a prevalent and devastating cancer lacking targeted therapies, the company is dedicated to developing tegavivint for this patient population.

HCC ranks as the sixth most commonly diagnosed cancer globally and the third leading cause of cancer-related deaths. The prognosis remains poor, with a low 5-year survival rate. Wnt activation contributes to various aspects of HCC pathogenesis, including tumor initiation, metastasis, and immune suppression. Patients with elevated nuclear beta-catenin and TBL1 levels have particularly dismal outcomes, highlighting the urgent need for novel therapeutic approaches.

Iterion Therapeutics, underscored the urgency for targeted therapies in HCC and tegavivint's potential to address this unmet clinical need effectively. The ongoing clinical trial aims to enroll approximately 35 patients with unresectable locally advanced or metastatic HCC who have failed previous systemic treatments. The trial will assess safety, efficacy, pharmacokinetics, and pharmacodynamics to establish a Recommended Phase 2 Dose (RP2D) for HCC. Tegavivint has already shown promising safety and activity in a Phase 1 study involving patients with desmoid tumors.



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