Nanotechnology is almost as beloved of oncology-focused medtech companies as it is of science fiction writers. Nano-scale beads are being developed for the intratumoural delivery of anticancer drugs or radioisotopes, to block the tumour’s blood supply or even to react with a magnetic field, burning the cancerous tissue away.
Nanobiotix is taking another tack: particles which are not active in themselves, but instead amplify the dose of standard radiotherapy. “If you ask a radio-oncologist what they need, they will tell you that anything that can improve the dose within the tumour without improving the dose in healthy tissue could bring benefits to patients,” the French company’s CEO, Laurent Levy, tells EP Vantage. “And that’s exactly what we are doing.”
Nanobiotix’s technology platform is called NanoXray, and is based on nanoparticles 50nm in diameter made of hafnium oxide, a largely inert compound called hafnia. Hafnium oxide is non-toxic and efficiently absorbs X-rays, Mr Levy says. If it is delivered accurately to the tumour, it can boost the effect of standard X-ray-based radiotherapy within the tumour – killing more cancerous cells than radiotherapy alone – while sparing healthy surrounding tissue.
The company has just reported its first clinical data. Interim results from the first 12 patients in a 27-patient phase I trial have backed the lead candidate, NBTXR3, in soft tissue sarcoma.
While no data on the therapy’s effects on survival or effects on patients’ quality of life are yet available, the data so far show that the particles stay in place in the tumour without leaking into the surrounding tissues – crucial if the therapy is to spare healthy cells. A few mild or moderate adverse events related to NBTXR3 were observed, the company conceded, but they resolved themselves.
NBTXR3 is at a more advanced stage than it might appear for a product that has not yet completed phase I: Nanobiotix does not intend to conduct phase III trials on the drug. “In Europe we have device status, so we can do a phase I pilot trial and then we go for a phase II, which is the registration phase,” Mr Levy says. This will enable the product to obtain CE mark and launch in Europe in 2017, he adds. US registration will follow.
And Mr Levy makes it clear that soft tissue sarcoma is just the first of many applications for the technology. As well as NBTXR3, Nanobiotix is also developing two other forms of the technology: an intravenously delivered version designed for the treatment of cancers such as lung cancer, where intratumoural injection is impractical, and a gel formulation intended to be applied to a surgical site following excision of a tumour, to help prevent recurrence. Both are at the preclinical stage.
The Paris company will not go it alone, Mr Levy says. “Given the number of indications we can target with such a technology, we decided to partner it, starting with Asia. The first product was partnered last summer with a company named PharmaEngine, concerning Asia-Pacific development and commercialisation.”
Mr Levy continues: “The metrics behind the deal have a total value of $57m plus royalties, up to two digits. But there is a key component in this deal: sharing data. Rather than having a small force to develop a small number of indications, here we have a bigger and wider agreement where we can share data. And our intent is to find a partner in the US too and do the same.”
Nanobiotix is already in talks, he says. “We have interacted with pharma companies for quite some time. Ideally we may not look at big pharma, but more a medium-size partner. We are not saying we will never partner with big pharma, but from an ideal point of view it may be better to have a medium-size partner that will have aligned interests with us where the success of NanoXray would be also their success.”
This success, if it comes, will not be a result of competing with other products, Mr Levy says. Products on the market include Sirtex’s SIR-spheres, plastic beads containing a payload of yttrium-90 to irradiate tumours from the inside (Sirtex’s tiny beads could see great success in liver cancer, April 22, 2013). BTG has recently acquired a similar technology from Nordion (BTG’s acquisition flurry underlines medtech interest, May 23, 2013).
Nanobiotix does not need to compete with products like these, Mr Levy contends, because its technology can be co-administered with them. “Our nanoparticles can be combined with regular X-rays of course – that’s what we are developing – but they can also be combined with radioisotopes and also with brachytherapy or with neutron therapy. Any source of radiotherapy can be used in combination with our product.”
As for chemotherapy, Mr Levy says: “We are not competing with existing [drug] products – we are adding a product that can be used in patients that usually [drugs] don’t treat.”
Mr Levy contrasts Nanobiotix's business model with that of MagForce, a company developing magnetic nanoparticles as a treatment for brain cancer (EP Vantage interview – Cancer survival could use the MagForce, April 17, 2013). “We enter an existing medical practice, without modifying it,” he says. “We just have one injection of the product prior to the first dose of radiotherapy. MagForce, when they want to provide their treatment, they have to create a new medical practice: they have to build equipment, train doctors, sell this equipment to a hospital – so that’s a new system that they have to develop, and that’s a huge cargo.”
“We are going where radiotherapy is not efficient enough, and any improvement in radiotherapy will make our product a better product,” Mr Levy says. “On the opposite, MagForce is not competing with us, but it’s competing with radiotherapy – and with a better radiotherapy with our product.”
Nanobiotix’s share price has risen 16% to €6.61 at time of publication on the strength of the interim phase I data. No efficacy data are yet available, but perhaps investors have concluded that with acceptable safety and a proven mode of action, proof of efficacy is a formality.
|Phase I safety, feasibility and dosing trial of intratumoural NBTXR3 in combination with radiotherapy||NCT01433068|