Onxeo S.A. announced that the first patient has been enrolled and treated in the phase 1b/2 clinical study that aims to evaluate the efficacy and tolerability of AsiDNA2, Onxeo's first-in-class DDR inhibitor, combined with radiotherapy in children, adolescents or young adults with relapsed High-Grade Glioma. The clinical validation of this innovative therapy offers the hope of providing better care and treatment for these high-risk pediatric cancers. High Grade Gliomas (HGG), which represents approximately 20% of tumors of the central nervous system in children, continue to have a very poor prognosis with a 5-year survival rate of less than 20%.

Surgery combined with radiotherapy or chemotherapy often allows the disease to be controlled. However, this disease control is not durable due to the development of treatment-resistant tumor cells. Studies conducted in preclinical models as well as initial clinical trials conducted in adults3 have highlighted AsiDNA's synergetic effect when combined with treatments that target and destroy the DNA, such as radiotherapy.

This phase 1b/2 trial, sponsored by Institut Curie, is being conducted within the framework of the European ITCC4 consortium, in order to evaluate AsiDNA's efficacy and tolerability by enrolling a maximum of 32 patients with relapsed HGG. A first patient has been enrolled in the study at the Institut Curie's SIREDO Center. Additionally, other French centers as well as European countries are planned to be initiated in the coming months.

The study's first interim results are projected in the first quarter of 2024.