NH TherAguix (NHT) announced that its lead drug candidate, AGuIX, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as a next-generation radio-enhancer for the treatment of malignant gliomas, and in particular glioblastoma (GBM), the most common and deadliest brain cancer globally. A nanodrug capable of improving the precision and effectiveness of radiotherapy without damaging surrounding tissues: The result of over 10 years of research, AGuIX is a nanodrug designed to meet the growing medical need in brain cancer, by significantly improving the efficacy and precision of radiotherapy directly within tumors. Its structure mostly made of gadolinium provides it with strong contrast imaging properties, coupled with the potential to indirectly increase the delivered X ray dose.

AGuIX thus enables precise tumor delineation via MRI and can significantly improve radiotherapy efficacy. AGuIX also boasts an excellent safety profile, as demonstrated by the results of the first In Human Phase Ib clinical trial NANORAD-1. Major clinical inflection points expected in the second half of 2024. AGuIX is currently being evaluated in four Phase II clinical trials, out of which three should provide major inflection points before the end of 2024: The Phase II NANORAD 2 study, conducted by Grenoble University Hospital (p.i. Pr.

C. Verry) on 100 patients with multiple brain metastases, is evaluating AGuIX in combination with whole brain radiotherapy. Recruitment has been finalized and results of the interim efficacy analysis are expected by the end of 2024 at the latest. The Phase II NANOBRAINMETS trial, conducted in collaboration with the Dana Farber Cancer Institute (p.i. Dr. A. Aizer), the world's leading institute for adult and pediatric cancer research and treatment, is evaluating AGuIX in 134 patients with brain metastases in combination with stereotactic radiotherapy.

A futility analysis (50% of patients enrolled) is scheduled for August 2024 to assess the first potential effects of the treatment on patients. Validation of the continuation of the study would underline the strong therapeutic potential of AGuIX in the treatment of these patients. Initial results from an interim efficacy analysis are then expected in November 2024.

The Phase I/II NANOGBM trial, conducted by Clermont Ferrand Centre Jean Perrin (p.i. Dr. J. Biau), is evaluating AGuIX in the treatment of glioblastoma in 62 patients. Results from the interim efficacy analysis are expected by the end of 2024.