Iterion Therapeutics Initiates Phase I Clinical Study of Tegavivint in Patients with Desmoid Tumors
Iterion Therapeutics, formerly known as Beta Cat Pharmaceuticals, today announced that it has initiated a multi-center Phase I clinical study of Tegavivint, its lead therapeutic candidate, in patients with desmoid tumors that are unresectable and symptomatic or progressive. The primary purpose of the study is to determine safety and the proper Phase 2 dose. Patients will also be monitored to measure durability of response and biomarkers for drug activity.
Tegavivint is a potent and specific inhibitor of nuclear beta-catenin activity and Wnt gene expression, both of which are implicated in a broad range of cancers. Beta-catenin also plays an important role in normal cell function. A unique characteristic of Tegavivint is that it has been shown in multiple non-clinical studies to inhibit beta-catenin’s role in activating cancer genes without affecting its role in maintaining normal tissue function.
Desmoid tumors are a rare, non-metastasizing, aggressive sarcoma affecting approximately 1,000 patients per year. They can have a devastating impact on pain and quality of life and in rare situations, are lethal. The growth of desmoid tumors is driven solely by mutations in nuclear beta-catenin signaling. There are currently no approved products for treatment of desmoid tumors and Iterion has received FDA Orphan Drug Designation for use of Tegavivint in this indication. In addition to desmoids, Iterion has demonstrated therapeutic potential for Tegavivint in multiple preclinical models of hematologic and solid cancers for which nuclear beta-catenin has been identified as a potential target.
The trial is being funded with proceeds from a recently closed $6 million Series B financing led by Sante Ventures that included GOOSE Society and AngelMD and a grant from the Cancer Prevention Research Institute of Texas (CPRIT).
“The closing of our Series B financing and initiation of a first-in-man study for Tegavivint are significant milestones for Iterion,” states Rahul Aras, Ph.D., President & CEO. “We are excited to advance the clinical development of Tegavivint for treatment of desmoids and to expand the program into other difficult to treat cancers.”
Iterion Therapeutics is a venture-backed, clinical stage biotechnology company developing novel targeted cancer therapeutics. The company’s lead product, Tegavivint, is a potent and selective inhibitor of the Wnt/b-catenin signaling pathway, implicated in cell proliferation, differentiation, immune evasion and stem cell renewal. Tegavivint demonstrates pre-clinical in vivo efficacy in several cancer models including desmoid tumors, acute myeloid leukemia (AML), osteosarcoma, and a range of solid tumor types. The Company is currently enrolling a Phase I clinical study of Tegavivint in patients with desmoid tumors at multiple clinical centers in the United States and Canada (https://clinicaltrials.gov/ct2/show/NCT03459469).
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