Iterion Therapeutics Announces Initiation of Phase 1/2 Clinical Trial to Study Tegavivint in Pediatric Cancers | Texas

HOUSTON, Nov. 9, 2021 /PRNewswire/ — Iterion Therapeutics, Inc., a venture-backed biotechnology company developing novel cancer therapies, today announced the initiation of a Phase 1/2 clinical trial to investigate tegavivint as a potential treatment for pediatric cancers, including sarcomas, lymphomas, and other solid tumors common in pediatric populations. This Children’s Oncology Group Pediatric Early Phase Clinical Trials Network (COG PEP-CTN)-sponsored study, led by Sarah Whittle, MD Assistant Professor, Department of Pediatrics, Section of Hematology-Oncology, Baylor College of Medicine and pediatric oncologist at Texas Children’s Cancer Center, began recruiting patients this month.

COG and PEP-CTN are National Cancer Institute (NCI) supported clinical research groups, comprising the world’s largest organization dedicated solely to childhood and adolescent cancer research, including early-stage trials. The PEP-CTN is committed to conducting early-stage clinical trials in pediatric cancer, building on the success of the Children’s Oncology Group (COG) Phase 1 & Pilot Consortium.

Tegavivint is a potent and selective first-class small molecule inhibitor of Transducin Beta-like Protein One (TBL1), a novel downstream target in the Wnt/beta-catenin signaling pathway. Beta-catenin and TBL1 expression are associated with metastasis and poor prognosis in a wide range of tumor types mainly found in pediatric populations. Tegavivint’s targeting of TBL1 prevents the formation of the TBL1/beta-catenin complex and specifically inhibits the oncogenic activity of beta-catenin without interfering with key cell membrane functions linked to toxicity common to other drugs in this pathway.

“We are thrilled to partner with COG-NCI to initiate this Phase 1/2 clinical trial of tegavivint as a potential targeted treatment for childhood cancer,” said Rahul Aras, Ph.D., CEO of Iterion. “Research with tegavivint suggests that it could be ideally suited for addressing a range of pediatric cancers based on its ability to inhibit TBL1 and, in turn, disrupt the oncogenic activity of beta-catenin. This unique mechanism of action, combined with the demonstrated safety of tegavivint profile in patients with desmoid tumors, provided the basis for COG PEP-CTN to initiate the phase 1/2 trial as a first step in the potential development of tegavivint for both solid and hematologic pediatric tumors.”

The Phase 1/2 clinical trial (COG study PEPN2011; ClinicalTrials.gov Identifier: NCT04851119) of tegavivint in pediatric cancers is fully sponsored by COG PEP-CTN, with support from Iterion, and will be conducted in their 21 consortium clinical centers, comprising the leading pediatric cancer centers in the United States.

“We welcome the opportunity to lead this clinical trial of tegavivint targeting TBL1, a novel therapeutic target in the Wnt signaling pathway implicated in multiple childhood cancers,” said Dr. Sarah Whittle, the study’s principal investigator. “This trial provides us with the opportunity to enrich our understanding of the utility of tegavivint in multiple cancer types that specifically affect children and for which few treatments other than chemotherapy exist.”

More than 16,000 children in the US1 and 400,000 worldwide2 are diagnosed with cancer each year, making it the leading cause of death from childhood illness3. Treatment options for children are limited and consist mainly of surgery, radiation and various chemotherapy.

dr. Aras continued: “Cancer is a devastating disease, but especially when it affects children. While current treatment options offer hope, they can be harsh on pediatric patients, leading to many unintended downstream consequences for survivors, such as heart and lung damage or secondary cancers.” including myelodysplastic syndrome, acute myeloid leukemia and solid tumors. The development of safer and potentially curative treatments that protect children from short- and long-term side effects remains a critical goal. We believe tegavivint holds such promise.”

The phase 1/2 trial of tegavivint in pediatric cancer patients follows compelling clinical data demonstrating the drug’s safety and clinical activity in adults with progressive and unresectable desmoid tumors. The phase 1/2a desmoid study included 24 patients who received tegavivint. The treatment was well tolerated with no observed dose-limiting toxicities in several patients treated for more than one year.

About Iterion Therapeutics

Iterion Therapeutics is a clinical-stage, enterprise-backed biotechnology company developing novel cancer therapies. The company’s lead product, tegavivint, is a potent and selective small molecule that binds to TBL1 in the nucleus and inhibits nuclear beta-catenin signaling and oncogenic activity. Research demonstrating potent antitumor activity in a wide variety of preclinical models indicates that tegavivint has the potential for clinical benefit in multiple cancer types. Tegavivint is currently the subject of a Phase 1 clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML) and a Phase 1/2 trial in pediatric patients with sarcomas, lymphomas and other solid tumors, excluding tumors of the central nervous system (CNS). . Iterion is also conducting a clinical program for non-small cell lung cancer (NSCLC), which has shown nuclear beta-catenin signaling to play a role. Data from a phase 1/2a clinical study with tegavivint in patients with progressive desmoid tumors demonstrated safety and preliminary clinical efficacy. Iterion is the recipient of a Product Development Award of up to $15.9 million from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information about Iterion, visit https://iteriontherapeutics.com.

About The Children’s Oncology Group (COG) and Pediatric Early Phase Clinical Trials Network (PEP-CTN)

COG (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. COG unites more than 10,000 pediatric cancer experts in more than 200 leading pediatric hospitals, universities and cancer centers in North America, Australia and New Zealand in the fight against childhood cancer. Today, more than 90% of the 16,000 children and adolescents diagnosed with cancer each year in the United States are cared for by COG member institutions. Research conducted by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG’s mission is to improve the cure rate and outcomes for all children with cancer.

COG PEP-CTN, funded by the NCI, is the largest early stage research organization dedicated to pediatric cancer, leveraging the expertise of 21 selected institutions within the COG based on their experience with novel therapies for childhood cancer. The COG PEP-CTN designs and conducts pediatric early phase studies, including Phase 1 studies that often include Phase 2 expansion cohorts. In addition, the PEP-CTN is conducting pilot studies of new agents/regimes to determine their tolerability so that promising agents/regimes can move to definitive testing in Phase 3 clinical trials

About Texas Children’s Hospital

Texas Children’s Hospital, a non-profit health organization, is committed to creating a healthier future for children and women around the world by leading the way in patient care, education and research. Consistently ranked as the best children’s hospital in Texas, and among the top in the nation, Texas Children’s has received widespread recognition for its expertise and breakthroughs in children’s and women’s health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for Pediatric Research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; and Texas Children’s Hospital The Woodlands, the first hospital dedicated to pediatric care for communities north of Houston. The organization also created Texas Children’s Health Plan, the nation’s first HMO for children; Texas Children’s Pediatrics, the largest pediatric primary care network in the country; Texas Children’s Urgent Care clinics that specialize in after-hours care specifically tailored to children; and a global health program that channels care to children and women around the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, visit www.texaschildrens.org. For the latest news, visit the online newsroom and Twitter at twitter.com/texaschildrens.

About Baylor College of Medicine

Baylor College of Medicine is a health sciences university that creates knowledge and applies science and discovery to further education, healthcare and community service locally and globally.

It is the only private medical school in the greater Southwest, ranking 22nd among medical schools for research and 17th for primary care, according to US News & World Report. The Baylor Children’s Program ranks 7th among all pediatric programs, reflecting its strong affiliation with Texas Children’s Hospital, where our faculty cares for pediatric patients and train our students and residents. Located at Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. More information about Baylor College of Medicine can be found on our website, https://www.bcm.edu/, on Facebook, http://facebook.com/BaylorCollegeOfMedicine, Twitter, http://twitter.com/bcmhouston, and LinkedIn, http://www.linkedin.com/company/baylor-college-of-medicine.

1 CA Cancer J Clin 2021; 71:7-33

2 Steliarova-Foucher E, Colombet M, Ries LAG, et al. International childhood cancer incidence, 2001-10: a population-based registry study. Lancet Oncol. 2017;18(6):719-731.

3 N Engl J Med 2018; 379: 2468-2475 DOI: 10.1056/NEJMsr1804754

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SOURCE Iterion Therapeutics

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