On November 3, 2021 NH TherAguix, a clinical stage company developing innovative nanomedicine for the treatment of cancer, and CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and Drug Products manufacturing company, reported the release of a new batch of AGuIX Drug Product for clinical trials (Press release, NH TherAguix, NOV 3, 2021, View Source [SID1234594559]).
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CARBOGEN AMCIS just released the fifth batch of AGuIX Drug Product since inception of the company. The release of this 3.7 kg batch added to previous available batches will secure the supply for hospitals and cancer centers that are involved in the clinical trials managed by the company. At present, 4 Phase1b/2 studies are recruiting (brain metastasis, cervix cancer, pancreatic cancer and lung cancer) and 3 are foreseen to start on other indications since already authorized by health authorities.
AGuIX combines three essential assets to fight tumors without changing the patient care. It has the potential to target, image (magnetic resonance imaging) and treat (radiosensitizing effect) cancer after intravenous injection. Its pharmacological potential is related to its innovative design that combines both a metal containing hybrid composition and a nanoscale structure.
The manufacturing of the fifth clinical batch of AGuIX Drug Product was performed at CARBOGEN AMCIS’ French site in Riom:
"We’ve manufactured several clinical batches of AGuIX Drug Product for NH TherAguix at our Riom site and we are delighted with the collaboration between our two companies on this exciting product that could make significant positive impact on patients." said Mark Griffiths, Dishman Carbogen Amcis Global CEO. "NH TherAguix has a bright future, and we are very proud to be a part of their innovation journey. We hope to be able to support them for many years to come, especially by offering them more production capacity at our new French state-of-the-art facility localised 7km away from our current Riom site and dedicated to custom development and commercial manufacturing of parenteral drug products, which will open its doors in early 2023."
The two companies have been collaborating on product development for seven years in the past. "CARBOGEN AMCIS was our first service partner for the production of the AGuIX Active Pharmaceutical Ingredient back in 2014 at their Swiss sites for a total of three successful campaigns. In 2019 the manufacturing of AGuIX API was transferred to Sanofi for scale-up purposes. However, we are very happy to work with CARBOGEN AMCIS from the inception of the project in 2015 on the Drug Product manufacturing at Riom site," said Michel Julien, head of CMC at NH TherAguix. "It has been and it is still a very structuring partnership for a rapidly growing young company like NH TherAguix to be backed by a manufacturer like CARBOGEN AMCIS".
About AGuIX: The drug candidate AGuIX, whose potential efficacy is based on nanoscale structuring, is administered by intravenous injection. It combines three essential assets to fight tumors and accessible from the same injection: target, image and treat. AGuIX technology is therefore part of the theranostic concept which corresponds to a combination of therapy (radiosensitizing effect) and diagnosis (visible in MRI), and more broadly in the personalized medicine of tomorrow, without changing the patient’s care path. Due to its biodistribution and mode of action, the nanomedicine AGuIX has a broad spectrum of action against solid tumors, 60% of which are treated by radiotherapy.