On June 10, 2024 NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions applicable to precision radiotherapy in oncology, reported the publication in the peer-reviewed journal Scientific Reports, part of the Nature group, of an article describing a method for quantifying its next-generation radio-enhancer, AGuIX, after tumor targeting (Press release, NH TherAguix, JUN 10, 2024, View Source [SID1234644425]). The article highlights the MRI biomarker properties of AGuIX in addition to its radio-enhancing properties when combined with radiotherapy.

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The article, entitled "Quantifying gadolinium-based nanoparticle uptake distributions in brain metastases via magnetic resonance imaging", can be found on the Scientific Reports website: Link.

AGuIX nanoparticles offer a breakthrough in radiotherapy, addressing a key challenge by increasing efficacy while preserving surrounding healthy organs. Prior to treatment, AGuIX serves as a biomarker visible on MRI, allowing for dose customization and image-guided irradiation to precisely target tumors and optimize therapy delivery. With its gadolinium-based structure, AGuIX provides strong contrast imaging properties, while its capacity to amplify X-ray doses at the tumor site further enhances radiotherapy effectiveness.

The recently published article in Scientific Reports highlights AGuIX’s potential as a biomarker in a study involving 23 patients with brain metastases. Each patient received either a 100 mg/kg intravenous dose of AGuIX or a placebo, with subsequent biodistribution and quantification analyses conducted. This investigation is part of the ongoing randomized Phase II NANOBRAINMETS trial at theDana Farber Brigham Cancer Centre in Boston, USA. The trial aims to evaluate the efficacy of AGuIX combined with stereotactic radiotherapy compared to stereotactic radiotherapy alone in patients with brain metastases. Quantification of AGuIX on MRI images revealed that patients who received AGuIX had nanoparticle concentrations in their brain metastases ranging from 0.012 to 0.17 mg/ml, with a mean concentration of 0.055 mg/ml. Patients receiving placebo showed no significant absorption in their brain metastases. These results confirm AGuIX ability to infiltrate brain tumors in significant quantities.

Additionally, these data indicate that AGuIX uptake by brain metastases was 35% higher than data from the Phase I NANORAD-1 trial previously conducted by NH TherAguix on 15 patients. In this trial, only 3 of the 15 patients had received the highest dose of 100 mg/kg, confirming a dose effect.

"We are very pleased that our collaboration with the Dana Farber teams is regularly expanding and confirming the clinical evidence data for AGuIX in the best possible conditions," said Olivier de Beaumont, CMO of NH TherAguix. "This publication is an acknowledgement of the research efforts made by the Dana Farber Cancer Institute teams, in collaboration with NHT teams, for the clinical development of our innovative nanomedicine. I would like to thank the Dana Farber Cancer Institute teams for the confidence they have shown in our project from the outset, as well as for their collaborative spirit, enabling us to enrich our knowledge of AGuIX."

The AGuIX radio-enhancer is currently being evaluated in four Phase II trials in several types of solid tumors, in combination with radiotherapy. Three of these studies are expected to produce significant results by the end of 2024.

Although radiotherapy has experienced significant advancements in recent years, numerous challenges persist in providing patients with the most effective and precise treatment available. This publication, alongside our recent Fast Track designation by the US FDA, underscores the potential of our nextgeneration radio-enhancer for treating brain metastases and glioblastoma, among the most lethal cancers globally. We firmly believe that the forthcoming results from our clinical trials, anticipated later this year, will chart a new course in therapeutic approaches for these medically urgent conditions," concluded Vincent Carrère, CEO of NHT.