NH TherAguix announces continuation of the Phase II NANOBRAINMETS trial in the treatment of brain metastases after completion of a futility analysis

Paris, France, September 03^rd, 2024 – NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions for precision radiotherapy in oncology, today announced that the Data Safety and Monitoring Board (DSMB) has validated the continuation of the Phase II trial, NANOBRAINMETS, managed by the Dana Farber Cancer Institute, following the futility analysis scheduled after the enrollment and follow up of 50% of patients in the study.

Ongoing evaluation of the study has revealed no serious adverse events related to the administration of AGuIX^®, highlighting the very favorable safety profile of this drug candidate. Developed by NH TherAguix, AGuIX^® is designed to improve tumor targeting and increase radiobiological damage to tumor tissue locally, thanks to its radiation signal amplification capabilities.

96 patients have been randomized up to date on the 134 scheduled in the study’s protocol.

NANOBRAINMETS is a randomized, double-blind Phase II trial evaluating AGuIX^® in combination with stereotactic radiotherapy in patients with brain metastases, compared with a control arm using stereotactic radiotherapy alone. Next interim analysis is currently expected by the end of this year to assess the clinical efficacy of AGuIX^®.

Dr. Ayal Aizer, MD, MHS, Director of the Central Nervous System Radiation Oncology Division at the Brigham and Women’s Hospital / Dana-Farber Cancer Institute, principal investigator of the NANOBRAINMETS study said: “We are very pleased to continue this cutting-edge clinical trial, which evaluates a promising new treatment for patients suffering from brain metastases. This study could lead to the development of a new standard of treatment for these devastating cancers, addressing a significant medical need today.”

Dr. Olivier de Beaumont, CMO of NH TherAguix said: “We sincerely thank Dr. Aizer and the teams at the Dana-Farber Cancer Institute for constant and fruitful collaboration of more than 10 years of research with NHT team”.

Vincent Carrère, CEO of NH TherAguix, added: "This first positive step paves the way for the major next inflexion point expected in the second half of the year regarding the interim efficacy analysis of AGuIX^®. The Phase II final results expected by Q2-Q3 2026 will be decisive for the further clinical development of AGuIX^® and its commercial approval for treating these cancers with high medical need.”
 

A propos de NH TherAguix : www.nhtheraguix.com

NH TherAguix is a late-stage biotech company developing AGuIX^® to treat tumours and metastases in patients treated by radiotherapy. It is estimated that c.60% of cancer patients undergo radiotherapy treatment today.

AGuIX^® is currently assessed in 4 Phase II randomized trials in brain metastases using either whole brain radiation therapy (NANORAD2, CHUGA, Grenoble, France) or stereo-radiosurgery (NANOBRAINMETS, Dana Farber Brigham Cancer Center, Boston, USA), in glioblastoma (NANOGBM, multicentric, Clermont Ferrand, France) as well as in pancreatic and lung cancers (NANOSMART, Dana Farber Brigham Cancer Center, Boston, USA).

Results of the First in Human Phase I trial in brain metastases (NANORAD1, CHUGA, Grenoble, France) and advanced cervix cancer (NANOCOL, IGR, Paris, France) have confirmed AGuIX^® safety and efficacy profile (Verry et al, Science Advances 2020, Verry et al. Radiotherapy & Oncology, 2021; Chargari et al, 2024 ACS Nano in press). To date more than 185 patients have been treated with AGuIX^®.

AGuIX^® has been extensively tested in various preclinical models and the results published more than 80 times in high impact publications. This innovation is protected by 18 patent families.

NH TherAguix was established in 2015 after 10 years of academic research in the founders’ laboratories that led to the invention of AGuIX^® and the discovery of its radiosensitizing effect.

Altogether, NH TherAguix raised around €40m of dilutive and non-dilutive funds, including a €13m A series in 2019, led by Bpifrance with Arbevel, Omnes and Supernova.