Per the agreement, Sanofi will manufacture, industrialize, and produce AGuIX – the radiosensitizing nanoparticle under clinical development for solid tumors, discovered by French start-up NH TherAGuIX.
Production of the drug will be done in both clinical and commercial batches by Sanofi at its Aramon, France site.
A spokesperson for Sanofi told us that start-up companies are interested in partnering due to its industrialization capabilities and relationship with health authorities.
“On Sanofi’s side, working with innovative and agile partners enable us to improve our ways of working, to get involved on new technologies," they further explained.
Sanofi stated that its Aramon facility has been certified by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (JPMDA).
Géraldine Le Duc, CEO of NH TherAguix, said in a statement that this partnership will enable large scale batch production for clinical trials and will be a major step forward in the development of the company, “at the crucial moment as we enter Phase II.”
The first clinical batches of the product are expected in September 2019. The drug candidate will be entering a Phase II study on the indication of brain metastases.
AGuIXis a nanoparticle that, according to the spokesperson, could enhance the ratio between X-Ray dose delivered to the tumor and normal tissues during radiotherapy by interacting with the X-ray.
“Presently no drug that could interact with radiotherapy and maximize its effects are available for the patients” the spokesperson explained.