AGuIX® is an innovative nanoparticle discovered by NH TherAGuIX, a French start-up based in Lyon and created in 2015 by Géraldine Le Duc and Olivier Tillement.
This radiosensitising drug is under clinical development in the treatment of solid tumors by radiotherapy, with an upcoming entry in Phase II on the indication of brain metastases.
Through this agreement, NH TherAGuIX will benefit from all the experience and industrial know-how of Sanofi in the field of production of active pharmaceutical ingredients (API).
Production of clinical and commercial batches will be carried out at the Aramon site in France, which is certified by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The first clinical batches are expected in September 2019.
Through this agreement, Sanofi will act as a processor for NH TherAGuIX, from the industrialisation of the manufacturing process to the production of clinical and commercial batches. The production of nanoparticles requires specific skills that have been acquired by Sanofi employees at the Aramon site and which today make it possible to develop this state-of-the-art expertise in France.
Director of Sanofi Active Ingredient Solutions Philippe Clavel said: “It is a great source of pride for Sanofi Active Ingredient Solutions to be able, through this strategic partnership, not only to contribute to a breakthrough innovation that could lead to a better life for millions of people in the field of oncology, but also to support a brilliant French start-up in its emergence and growth.
“We are proud and excited about this partnership with Sanofi, which will enable larger scale batch production for clinical trials and, hopefully, the production of commercial batches. This is a major step forward in the development of the company, at the crucial moment as we enter Phase 2,” said Géraldine Le Duc, CEO of NH TherAguix.
AGuIX is a bimodal nanomedicine, with a radiosensitising effect and visible in magnetic resonance imaging (MRI).
AGuIX demonstrated good post-injection safety, MRI contrast enhancement and early evidence of radiosensitisation when combined with radiation therapy in patients with brain metastases (NANORAD1 Phase Ib trial, Grenoble CHU). A Phase II trial has recently been approved by ANSM (NANORAD2, CHU Grenoble). In parallel, a Phase Ib trial for advanced cancer of the cervix (NANOCOL1) is underway at Gustave Roussy in Paris.