Nanobiotix Appoints CordenPharma as Manufacturing Partner

Mar 18, 2015
Paris, France, 18 March, 2015 – Nanobiotix (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces it has appointed CordenPharma as its manufacturing partner. The opening of a new manufacturing line and the scaling up of production is an important step in NBTXR3’s route to its commercialization.
The new manufacturing line, located in France, will increase the amount of NBTXR3 product available. With an anticipated award of a CE mark in 2016, the Company is preparing to scale-up production further to meet the needs of future commercialization. Furthermore, Nanobiotix is anticipating future demand from clinical trials in the coming years in Europe and in the United States. 
CordenPharma is an international full-service CDMO (contract manufacturing organization) which provides specialised technologies for the development and manufacture of health products. The company is recognized by the EMA and FDA, thanks to its eight cGMP facilities across Europe and the United States, and works with both pharma and biotech companies. Its facilities are regularly inspected by the regulatory authorities (FDA and EMA) and have a good track record.
Laurent Lévy, Chief Executive Officer at Nanobiotix, commented: “Finding the right manufacturing partner is essential, since ensuring quality and sufficient levels of supply is fundamental for meeting the market demands and the growth of the Company.”
Yves Michon, Président, CordenPharma Chenôve, said: “Nanobiotix’s product, NBTXR3, is a fascinating product – not only with respect to its properties, but also in its manufacture. We are working closely with Nanobiotix to ensure a seamless process and manage the scale-up of the product.
NBTXR3 is Nanobiotix’s lead product in the NanoXray portfolio. The product comprises Hafnium Oxide nanoparticles which can be injected directly into tumor. With the application of radiotherapy, these nanoparticles absorb X-rays have the potential to significantly enhances the radiation dose within the cancer cells without increasing the dose to the surrounding healthy tissues. NBTXR3 has the potential to cause a paradigm shift in cancer therapy with significant clinical benefit for patients.
In November 2014, Nanobiotix announced its global clinical development plan. Beyond Soft Tissue Sarcoma and Head and Neck cancer, it now includes metastatic liver cancer, hepatocellular carcinomas and prostate cancer. In the second half of 2015, the liver cancers and high risk prostate cancer programs are anticipated to enter the clinical stage.  

Read the full press release here.