NH TherAguix SAS : announces communications to be presented at the AAPM meeting by Harvard Medical Schools collaborators

NEWSLETTER

NH TherAguix

announces communications to be presented at the AAPM meeting by Harvard

Medical School collaborators

Meylan, France, July 21, 2023

NH TherAguix is happy to announce that 4 communications related to AGuIX will be provided during the American Association for Physicists in Medicine annual meeting in Houston, Texas, USA (https://www.aapm.org/announcements/2023AMRFP.asp) by our US collaborators. These communications are issued from our collaboration with the Dana Farber/Brigham and Women's Cancer Center (Boston, USA), through the Phase 1/2 NanoSmart clinical trial on pancreatic cancer (P.I. Dr. Jonathan Leeman), the Phase 2 NanoBrainMets clinical trial (P.I. Dr Ayal Aizer), as well as NIH funded project "Translation of a Bi-Gd Nanoparticle for MR-guided Radiation" (P.I. Dr Ross Berbeco). Many thanks to our US colleagues at Dana Farber/Brigham and Women's Cancer Center (Boston, USA) for their collaboration in our project.

Additionally, Léna Carmès, NH TherAguix CIFRE PhD student supervised by ILM (Lyon University), joined Ross Berbeco's Lab for 4 months starting from April 14th, as a visiting student in the frame of our NIH granted project "Translation of a Bi-Gd Nanoparticle for MR-guided Radiation". Her project began in 2020 and focuses on the development and preclinical proof-of-concept of new products based on our nanohybrid technology according to a patented process of fabrication. During her stay in the Berbeco's Lab, Léna will be trained in biological experiments and will strengthen the team there for providing a full set of preclinical proof-of-concept on the new products.

About NH TherAguix (www.nhtheraguix.com) :

NH TherAguix, headquartered in Meylan (France), is a Biotech clinical development company. Its candidate drug AGuIX® has been developed to increase the effectiveness of radiation therapy that affects 60% of cancer patients. By its radiosensitizing effect, AGuIX® increases the dose difference between the dose of X-rays received by tumors and received by the surrounding healthy tissues. Its clinical effectiveness is based on a nanometric structuring that allows intravenous injection and the combination of three essential properties to fight tumors: target, image and treat. AGuIX® is therefore part of the concept of theranostic, which corresponds to the combination of therapy (radiosensitizing effect) and diagnosis (visible in MRI), and more generally precision medicine.

AGuIX® has first been extensively tested in various preclinical models and the results published in high impact publications (>80 papers). The innovation is protected by 17 patent families.

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As of today, the product has been injected in ~140 patients with no safety issues. Results of the First In Human Phase I trial in brain metastases (NANORAD1, 15 pts/15, France) so far have confirmed the triple effect: targeting, imaging and treatment and doses safety profile (Verry et al, Science Advances 2020, Verry et al. Radiotherapy & Oncology, 2021). AGuIX® is currently undergoing two Phase II randomized trials in brain metastases using either whole brain radiation therapy (NANORAD2, 100 patients out of a planned 100 have been accrued, 14 clinical centers, France) or stereo-radiosurgery (NANOBRAINMETS, 60 patients out of a planned 134 have been accrued, Dana Farber / Brigham and Women's Cancer Center, Boston, USA). In parallel, three other exploratory trials are underway with significant news flow to be delivered Q4-23/Q1-24: a Phase Ib-II trial for pancreatic and lung cancers (NANOSMART, 32 patients out of a planned 100 have been accrued, Dana Farber / Brigham and Women's Cancer Center, Boston, USA), a Phase Ib-II trial for glioblastoma (NANOGBM, 8 patients out of a planned 66 have been accrued, multicentric, Clermont Ferrand, France), and a Phase Ib trial for advanced cervix cancer (NANOCOL, 12 patients out of a planned 12 have been accrued, Gustave Roussy, France).

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