The excitement that has greeted confirmation of positive results from an early trial of NBTXR3, a nanoparticle therapy for soft tissue sarcoma (STS) under investigation by Nanobiotix, suggests that the frenzy in biotech is bleeding into medtech. Shareholders sent the stock up 63% on Euronext Paris yesterday and a further 60% in early trade today.
No new data were released, though a decent safety profile was highlighted. The shares spiked not on what has occurred, but what will: Nanobiotix says that the results should allow it to obtain CE mark for the product in 2016, a year earlier than expected.
Nanobiotix’s NanoXray technology involves infusing nanoparticles made of hafnium oxide into tumours. These particles absorb X-rays, amplifying the effect and increasing the precision of radiotherapy (EP Vantage interview – Nanobiotix’s particles boost radio signal in phase I, June 3, 2013).
The independent data-monitoring committee overseeing the pilot trial of NBTXR3, Nanobiotix’s lead project, this week gave a positive assessment of the data, according to the company. As a result of this, as well as "expert opinions" and "encouraging signs of efficacy", a pivotal trial will start later this year, it said.
NBTXR3 is also in a pilot study in elderly patients with head and neck cancers, and Nanobiotix is also developing it for liver cancer, though this programme has not yet reached the clinic.
The questions now focus on the company’s plans for licensing. A development and commercialisation arrangement for NBTXR3 worth up to $57m is already in place, the Taiwanese company PharmaEngine having acquired Asia-Pacific rights in August 2012. PharmaEngine is expected to start trials in advanced rectal cancer and advanced mouth cancer in the second half of this year.
Should CE mark arrive as scheduled in two years’ time, Nanobiotix intends to oversee European sales efforts in-house. But it has been sounding out potential US partners for some time. If the accelerated approval timeline can animate shareholders, perhaps it can also galvanise partners.
Nanobiotix’s CEO, Laurent Levy, told EP Vantage last year that one of the technology’s key advantages was its cost-effectiveness. Stating that the regulatory authorities in all territories are increasingly moved by pharmacoeconomic output, Mr Levy said Nanobiotix’s therapy was relatively cheap, involving the addition of just one step to the treatment process – most STS patients, as with 60% of all cancer patients, receive radiotherapy as standard.
Doubtless this will help nudge potential partners towards the company. One thing that would help far more, however, is release of the full phase I data on NBTXR3, allowing interested parties to judge just how much of a difference this therapy can make to patients’ lives.
|Phase I safety, feasibility and dosing trial of intratumoural NBTXR3 in combination with radiotherapy||NCT01433068|