AGuIX Gains FDA Fast Track Status in Malignant Gliomas and Glioblastoma

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• AGuIX has received a fast track designation from the FDA for the treatment of malignant gliomas and glioblastoma.

• AGuIX is currently being evaluated in 4 phase 2 clinical trials, with 3 studies (NANORAD2, NANO-GBM, and NANOBRAINMETS) expected to provide interim efficacy data by the end of 2024.

• The agent, composed primarily of gadolinium, offers strong MRI contrast imaging capabilities for precise tumor delineation.

The FDA granted a fast track designation to AGuIX for treating malignant gliomas and glioblastoma, according to a press release from NH TherAguix.¹

AGuIX is a nanodrug composed mostly of gadolinium. It offers strong contrast imaging capabilities which allows for precise tumor delineation using MRI. It also has the potential to indirectly improve the efficacy of radiotherapy.

AGuIX has demonstrated a manageable safety profile, as seen in data from a first-in-human, phase 1b trial titled NANO-RAD-1 trial (NCT02820454).

“We are delighted to have received this FDA fast track designation for AGuIX in the treatment of [patients with] malignant glioma,” said Vincent Carrère, chief executive officer of NH TherAguix, in a press release. “It demonstrates the strong interest of the US regulatory authorities in our next-generation radio-enhancer. We are convinced that AGuIX holds great potential to offer an effective clinical and therapeutic response to patients suffering from these deadly cancers, for whom existing treatments remain largely insufficient. 2024 should be a major turning point in the development of our promising nano-drug, and we look forward to sharing the first results from our clinical trials later this year.”

AGuIX is currently undergoing evaluation in 4 phase 2 clinical trials. Three of these studies, NANORAD2 (NCT03818386), NANO-GBM (NCT04881032), and NANOBRAINMETS (NCT04899908), are expected to provide data updates by the end of 2024.

The first, NANORAD2, is evaluating AGuIX in combination with whole brain radiotherapy for the treatment of 100 patients with brain metastases. The study has finished recruitment and expects interim efficacy results by the second half of 2024.

NANOBRAINMETS is a study looking to assess AGuIX when given with stereotactic radiotherapy. Approximately 134 patients with brain metastases are being evaluated in the study and findings from the interim efficacy analysis are anticipated in November 2024.

NANO-GBM is a phase 2 study assessing treatment with AGuIX in approximately 62 patients with glioblastoma. The interim efficacy analysis of NANO-GBM is expected by the end of 2024.

“Glioblastoma [is] the most common type of malignant primary brain tumor and accounts for most deaths among patients with primary tumors,” Olivier de Beaumont, chief medical officer of NH TherAguix, said in the press release.

“Although there has been progress in understanding the biology of these tumors, the unmet therapeutic need remains very important. This fast track designation will facilitate NH TherAguix more frequent interactions with the FDA as well as accelerated approval and priority review in glioblastoma indications. This program will be led in parallel to our ongoing clinical development program in brain metastases, where [a] preliminary signal of efficacy of AGuIX has already been detected,” added de Beaumont.

REFERENCE

1. NH TherAguix receives FDA fast track designation. News release. NH TherAguix. May 30, 2024. Accessed May 30, 2024. https://www.globenewswire.com/news-release/2024/05/30/2890749/0/en/NH-TherAguix-receives-FDA-Fast-Track-designation.html