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.

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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.