NH TherAguix Announces Publication of Groundbreaking Study on AGuIX® Nanoparticles Enhancing Cervical Cancer Treatment

PRESS RELEASE

NH TherAguix Announces Publication of Groundbreaking Study on AGuIX® Nanoparticles Enhancing Cervical Cancer Treatment

• Key clinical milestone showcasing the potential of AGuIX®, a next-generation nanodrug developed by NH TherAguix to improve tumor targeting and augment efficacy when combined with chemoradiationand brachytherapy.
• Phase I clinical trial results demonstrate safety, tolerance, and promising therapeutic outcomes in locally advanced cervical cancer patients.

Paris, France, Wednesday July 3^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 the publication of a pioneering study in American Chemical Society (ACS) Nano, a high impact factor journal. The study, titled "Theragnostic gadolinium-based nanoparticles safely augment X-ray radiation effects in patients with cervical cancer", provides compelling evidence supporting the use of AGuIX® nanoparticles to selectively enhance the effectiveness of radiotherapy in cervical cancer treatment.

AGuIX®: A nanodrug capable of improving the precision and effectiveness of radiotherapy

The culmination of over a decade of research, AGuIX® nanoparticles are designed to meet the critical medical need for more effective cancer treatments, including advanced cervical cancer. These gadolinium-based nanoparticles enhance MRI contrast, allowing for precise tumor visualization, and significantly amplify the radiation dose delivered to tumor tissues, thereby improving the efficacy of radiotherapy.

Study Highlights:

• Safety and Tolerance: The Phase I clinical trial involving 12 patients with locally advanced cervical cancer demonstrated that AGuIX® nanoparticles have an excellent safety profile, with no dose-limiting toxicities and no severe side effects observed, especially when combined with brachytherapy or cisplatinum-based chemoradiation.
• Enhanced Imaging and Treatment: Based on AGuIX® quantification through MRI, treating physicians can determine the optimal radiotherapy dose for each patient.
• Efficacy: All patients (n=12) achieved complete remission of the primary tumor, with only one instance of distant tumor recurrence, i.e. 8% compared to 30-40% recurrence according to historical studies. The study confirms the relationship between tumor accumulation, quantification, and encouraging tumor response signals: an estimated dose enhancement factor of about 15% at 2 Gy per tumor has been observed, a meaningful increase that generates a biological response sufficient to achieve tumor control and improved outcomes for patients.
• Rapid Clearance: The nanoparticles are rapidly cleared from the body, minimizing potential side effects and allowing for efficient imaging and treatment cycles.

Dr. Olivier de Beaumont, CMO of NH TherAguix, emphasized the significance of these findings:"This study marks a significant advancement in the use of AGuIX® as a novel option for cancer treatment. The ability to quantify AGuIX® concentration in correspondence with tumor response signals with high precision opens new avenues for personalized medicine in oncology using companion MRI-based information."

Vincent Carrère, CEO of NH TherAguix, commented:"We are thrilled to announce this important publication in ACS Nano. I would like to thank the teams at IGR, especially Professors C. Chargari and E. Deutsch, for this remarkable clinical and translational work. It highlights the transformative potential of AGuIX® in enhancing radiotherapy for cervical cancer patients. These promising results reinforce our commitment to advancing innovative cancer treatments and improving patient outcomes."

About NH TherAguix: www.nhtheraguix.com

NH TherAguix is a late-stage biotech company developing AGuIX® to treat tumors and metastases in patients undergoing radiotherapy. It is estimated that approximately 60% of cancer patients receive radiotherapy. AGuIX® is currently being assessed in multiple Phase II randomized trials across various cancer types, including brain metastases, glioblastoma, and pancreatic and lung cancers.

To date, over 190 patients have been treated with AGuIX®. This innovation is protected by 18 patent families and has been extensively tested in various preclinical models, with results published in more than 80 high-impact publications.

NH TherAguix was established in 2015 following 10 years of academic research that led to the invention of AGuIX® and the discovery of its radiosensitizing effect. The company has raised approximately €40m of funds, including a €13m Series A in 2019 led by Bpifrance with Arbevel, Omnes, and Supernova.

Media contacts:
NH TherAguix
NewCap - Arthur Rouillé
arouille@newcap.fr
+33 (0)1 44 71 00 15