Nanobiotix, a late clinical-stage nanomedicine company focused on developing cancer treatments, has named CordenPharma, a contract development and manufacturing organization of active pharmaceutical ingredients, biologics, and packaging, as its manufacturing partner, which involves the opening of a new manufacturing line and the scaling up of production for NBTXR3's, Nanobiotix’s lead product in the NanoXray portfolio. The product comprises hafnium oxide nanoparticles that can be injected directly into a tumor. With the application of radiotherapy, these nanoparticles absorb X-rays and have the potential to enhance the radiation dose within the cancer cells without increasing the dose to the surrounding healthy tissues.

The new manufacturing line, located in France, will increase the amount of NBTXR3 product available. With an anticipated award of a CE mark (a designation indicating a product's compliance with EU legislation to enable the free movement of products within the European market) 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. Currently, NBTXR3 is classified as a medical device in Europe and a drug in the United States

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. Nanobiotix is based in Paris, France and opened an affiliate office in the Boston in September 2014.

Source: Corden Pharma