Successful completion of recruitment in NANORAD 2, a Phase 2 Clinical Trial of AGuIX® with whole brain radiation therapy in brain metastasis

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Successful completion of recruitment in NANORAD 2, a Phase 2 Clinical Trial of AGuIX® with whole brain radiation therapy in brain metastasis

• Recruitment led by Grenoble Alpes University Hospital, driven by strong clinical sites participation and investigator support
  
  
• Topline data expected in Q4 2024
  
  

Paris (France), November, 30^th 2023 – NH TherAguix a Phase 2 biotech company developing AGuIX®, an innovative nanodrug to improve cancer treatment by radiotherapy, announces the completion of recruitment in its NANORAD 2 Phase 2 clinical trial, randomized, multi-center study assessing safety and efficacy of AGuIX® in combination with whole brain radiation therapy versus whole brain radiation therapy alone, in adult patients with multiple brain metastasis.

NANORAD 2¹ is a prospective randomized (1:1) open label trial with a total of 100 patients recruited in 14 active centers coordinated by Dr Camille Verry (CHUGA, Grenoble-Alpes, France) as principal investigator. This trial combines the radiotherapy standard of care for multiple brain metastasis patients, whole brain radiation therapy, with 3 intravenous injections of AGuIX® at 100 mg/kg. The best objective response rate as main endpoint as well as safety, quality of life, neurocognitive function, intracranial PFS and OS as secondary end points will be evaluated once the follow-up of the last patient will be over. NH TherAguix expects to report topline data in the last quarter of 2024.

Dr. Olivier de Beaumont, Chief Medical Officer of NH TherAguix says: “The completion of recruitment in NANORAD 2 trial is a critical achievement for NH TherAguix.We aim to introduce innovative treatment alternatives for patients coping with multiple brain metastases, addressing unmet medical needs. This commitment has led us to contemplate a late-stage clinical development program in Neuro Oncology. We’re extremely grateful to the Grenoble Alpes University Hospital and Dr. Camille Verry. The collective dedication of all collaborators from the 14 participating centers played a pivotal role in the successful completion of the trial.”

Dr. Camille Verry, principal investigator of this clinical study and national coordinator from Grenoble Alpes University Hospital, says: “In NANORAD 2 trial, we have been looking to replicate the excellent safety profile of AGuIX^® with whole brain radiation therapy we had observed in the previous NANORAD Phase 1b dose escalation study (“First-In-Man”). I am confident that with the combination of radiotherapy with a gadolinium-based nanoparticle (AGuIX^®) we will also demonstrate an improvement of radiotherapy efficacy in patients will multiple brain metastases”.

Previous results issued from the First-In-Man NANORAD trial ^3,4,5

As a reminder, this Phase 2 trial follows the results issued from the First-In-Man trial NANORAD that allowed to assess favorably AGuIX® in terms of tolerance after intravenous administration in combination with conventional whole brain radiation therapy (10 x 3Gy) in patients with multiple brain metastases. Five dose levels (15, 30, 50, 75 and 100 mg/kg) of a single intravenous injection of AGuIX^® were successfully tested on 15 patients with a total of 354 brain metastases from 4 types of primary cancers (melanoma (n=6), lung cancer (n=6), colon cancer (n=1) and breast cancer (n=2). This trial demonstrated that the combination of AGuIX with radiotherapy for these patients is safe and feasible as well as the distribution of AGuIX^® in tumors and its renal elimination. AGuIX^® specifically targeted brain metastases and was retained within tumors for up to one week, allowing radioenhancement throughout the duration of the treatment. Finally, a clinical benefit according to RECIST v1.1 (partial response or stable disease) was established for 13 over 14 evaluable patients.

Follow-up of a patient treated by a combination of RT and AGuIX (Nanorad - Phase I – First-In-Man)

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In parallel to NANORAD 2, NH TherAguix is supporting NANOBRAINMETS², an ongoing Phase 2, randomized, double-blind, assessing safety and efficacy of AGuIX^® in combination with stereotaxic radiosurgery. This highly complementary trial, led by Dr. Ayal Aizer (Dana Farber Cancer Institute/Harvard, US) is making rapid progress.

For patients with multiple brain metastases, despite advances in stereotactic radiosurgery and new systemic treatments (immunotherapy and targeted therapy for example), estimates of overall survival at 2 years and at 5 years for all types of primary tumors are approximately 8% and 2% respectively. The median overall survival is less than 6 months and new approaches need to be developed to improve the treatment of these patients. The pharmacological properties and the mode of action of AGuIX^®, by bio-distribution and interaction with X rays, allow it to act at the very core of tumors and confer it a pan cancer potential. This is a tremendous hope for many patients whose medical needs are currently unmet.

Notes for Editors:

1. https://clinicaltrials.gov/study/NCT03818386
2. https://clinicaltrials.gov/study/NCT04899908
3. 3-Verry C, Sancey L, Dufort S, Le Duc G, Mendoza C, Lux F, Grand S, Arnaud J, Quesada JL, Villa J, Tillement O, Balosso J. Treatment of multiple brain metastases using gadolinium nanoparticles and radiotherapy: NANO-RAD, a phase I study protocol. BMJ Open. 2019 Feb 11;9(2).
4. Verry C, Dufort S, Lemasson B, Grand S, Pietras J, Troprès I, Crémillieux Y, Lux F, Mériaux S, Larrat B, Balosso J, Le Duc G, Barbier EL, Tillement O. Targeting brain metastases with ultrasmall theranostic nanoparticles, a first-in-human trial from an MRI perspective. Sci Adv. 2020 Jul 15;6(29).
5. Verry C, Dufort S, Villa J, Gavard M, Iriart C, Grand S, Charles J, Chovelon B, Cracowski JL, Quesada JL, Mendoza C, Sancey L, Lehmann A, Jover F, Giraud JY, Lux F, Crémillieux Y, McMahon S, Pauwels PJ, Cagney D, Berbeco R, Aizer A, Deutsch E, Loeffler M, Le Duc G, Tillement O, Balosso J.Theranostic AGuIX nanoparticles as radiosensitizer: A phase I, dose-escalation study in patients with multiple brain metastases (NANO-RAD trial). Radiother Oncol. 2021 Jul;160:159-165.
   
   

About NH TherAguix (www.nhtheraguix.com)

NH TherAguix is a Phase 2 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) have confirmed AGuIX® safety and efficacy profile (Verry et al, Science Advances 2020, Verry et al. Radiotherapy & Oncology, 2021). 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 patents families.
NH TherAguix was established in 2015 after 10 years of academic research that led to the invention of AGuIX® and the discovery of its radioenhancement 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.

NH TherAguix Contact :

Florence CRUZ

cruz@nhtheraguix.com

+33 6 63 43 19 96

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