Iterion Therapeutics has announced the start of a Phase I/II clinical trial to assess tegavivint in treating paediatric cancers.

Tegavivint is a small molecule inhibitor of the Transducin Beta-like Protein One (TBL1), which is a novel target in the Wnt/beta-catenin signalling pathway.

It binds to TBL1 to prevent nuclear beta-catenin signalling and oncogenic activity.

In the clinical trial, the inhibitor will also be investigated as a potential treatment for lymphomas, sarcomas and other solid tumours that are common in paediatric populations.

Baylor College of Medicine Haematology-Oncology Section Pediatrics Department assistant professor Sarah Whittle is leading the Phase I/II clinical trial, which has already started enrolling patients this month with recurrent or refractory solid tumours, including sarcomas and lymphomas.

Children’s Oncology Group Pediatric Early Phase Clinical Trials Network (COG PEP-CTN) is sponsoring the trial, with support from Iterion.

Iterion stated that the Phase I/II study will be conducted at 21 consortium clinical centres, which include the leading paediatric cancer centres in the US.

Iterion CEO Rahul Aras said: “We are very pleased to collaborate with COG-NCI to initiate this Phase 1/2 clinical trial of tegavivint as a potential targeted treatment for paediatric cancers.

“Research involving tegavivint suggests that it could be ideally suited to addressing a range of paediatric 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 tegavivint’s demonstrated safety profile in desmoid tumour patients, formed the basis for COG PEP-CTN to initiate the Phase I/II trial as a first step in the potential development of tegavivint for both solid and haematologic paediatric tumours.”

The company noted that the new Phase I/II study follows positive clinical data obtained from the Phase I/IIa desmoid study conducted in 24 adult subjects with progressive and nonresectable desmoid tumours.

According to the data, tegavivint was well-tolerated and dose-limiting toxicities were also not observed.