Introduction

” See what you target, target what you see”     

NH TherAguix is a clinical stage pharmaceutical company developing innovative nanomedicine that improve radiation therapy benefits without modifying current clinical workflows. Our leading product, AGuIX® is a nanoparticle designed to selectively target solid tumors in order to improve their localization of and the outcomes of radiation therapy after intravenous injection.

Currently, ~2/3 of cancer patients receive radiation therapy during their treatment. One of the main radiation therapy challenges is to deliver a sufficient radiation dose in the tumor while sparing the surrounding healthy tissues.

AGuIX®  plays a key role in radiation therapy. Combined with the radiation therapy, AGuIX® amplifies the radiation efficacy locally in the tumor by acting as a radioenhancer and a radiosensitizer. This technology allows to treat radioresistant cancers and to minimize the radiation therapy secondary effects by decreasing the dose to healthy tissues.

AGuIX®  plays a key role in imaging. Combined with MRI, AGuIX® allows an increase of tumor contrast after injection, helping the physician to localize and delineate with accuracy the tumor region. AGuIX® also allows to personalize the radiation therapy treatment for each patient by determining the optimal moment to perform the irradiation and where eventually to focus it.

AGuIX® technology  is protected by 7 international patents in exclusive license and 3 patents in co-property and its efficacy has been demonstrated in 60+ scientific peer-reviewed international publications.

The production of a first clinical batch of AGuIX® under cGMP conditions has successfully been performed together with the related validation of the toxicity and stability tests required by the French regulatory office (ANSM). The production of a second clinical batch is currently under progress.

AGuIX® product is today involved in  2 Phase 1 b clinical trials. The first “in man injection” has been performed in July 2016 within the so-called NANORAD trial, a phase I clinical trial on multiple brain metastasis in partnership with the Grenoble University Hospital. So far, 12 patients out of 15 planned in this dose-escalating study have been already involved corresponding to the 4 first doses of AGuIX® nanodrug (15; 30; 50; 75 mg/kg). First results show a good tolerance of the product as well as highly favorable biodistribution and pharmacokinetics. First evidences of dose-related effects of the product on brain metastasis have also been noticed already accounting for the design of a NANORAD phase II trial which will start early 2018. NANOCOL, a phase Ib clinical trial on cervical cancer in partnership with Institut Gustave Roussy, has been recently approved by the French-FDA (august 2017) for a starting date late 2017.

NH Theraguix is currently seeking for funds to develop its pipeline, focused on brain tumor (glioma and brain metastasis using various radiotherapy techniques such as SRS, WBRT and conformal RT) as well as other extracranial indications.