Nanobiotix has been given the green light by French regulators to start a Phase II/III registration trial of NBTXR3, in patients with locally advanced soft tissue sarcoma.

NBTXR3 comprises nanoparticles made of hafnium which can be injected directly into cancer cells. A Phase I study caused a stir at the American Society of Clinical Oncology meeting in Chicago in June when patients with inoperable, advanced soft tissue sarcoma were able to successfully undergo surgical resection after radiotherapy with NBTXR3.

The study will start in France and then be conducted in up to 30 sites throughout Europe once further authorisations are received. The company, a spin-off of the State University of New York at Buffalo and now based in Paris, France, added that it is establishing “industrialisation, market access and reimbursement strategies for NBTXR3 to prepare for a potential product launch at the end of 2016”.

Nanobiotix chief executive Laurent Levy said that following the ASCO results, “this approval is the second most important step we have accomplished this year as it launches the last clinical phase”. He added that NBTXR3 will offer “meaningful clinical benefit for patients with advanced sarcomas where there are serious unmet medical needs”.