Een mooi en duidelijk verhaal in UK today. Hieruit blijken wel de mogelijkheden voor Nanobiotix in een enorme markt.
Pace quickening for Nanobiotix as promises radiotherapy revolution
By Ian Lyall March 05 2015, 9:26am If the company is able to broaden out applications for NBTXR3 then there is a potential multi-billion euro opportunity for Paris-based NanobiotixIf the company is able to broaden out applications for NBTXR3 then there is a potential multi-billion euro opportunity for Paris-based Nanobiotix
The pace of progress has ramped up several notches in the past year at Nanobiotix (EPO:NANO), developer of a nano-medical technology that promises a revolution in radiotherapy.
Impressive early results treating soft tissue sarcoma – tumours that lodge and grow in fat and muscle – have allowed the company to progress into the registration phase for its lead product, NBTXR3.
Not just that, Nanobiotix has successfully raised enough cash to fund studies here in Europe up to market and also initiation of clinical development in the US, the world’s largest medical market.
And it is also rapidly expanding indications for NBTXR3 to treat other cancer types.
It means that unlike a traditional fledgling biotech, Nanobiotix has multiple shots on goal.
If the company is able to broaden out applications for NBTXR3 then there is a potential multi-billion euro opportunity for Paris-based Nanobiotix.
To understand the market opportunity you have to be familiar with how the technology works.
The process is fairly simple. Particles of hafnium oxide are injected directly to the tumour, although they can be administered intravenously or applied as a gel during surgery to give a targeted treatment.
The non-toxic material is there to absorb x-rays as well as enhance the dose of radiotherapy. This targeted approach means the dose in the tumour can be increased without hurting healthy tissues surrounding it.
It should be stressed that, while the NanoXray can be administered like a medicine and its particles are so tiny, thousands can fit around the circumference of a hair, the reaction is physical rather than chemical or biological.
This is an important distinction. For while medicines react differently to the genetic make-up of each individual, the laws of physics are immutable.
So, we know if we heat a cell to 80 degrees or similarly give a high dose of radiotherapy that cell – hopefully a dangerous cancer cell – will die no matter what the genetic make-up of the patient.
What does this mean? Well, it creates a one-size-fits-all approach to treatment that you just don’t have with conventional medicine.
Theoretically then, six million people annually who receive radio-therapy could be helped with this new enhanced form of the treatment.
The other upside is the regulatory pathway for NBTXR3 should be much shorter than the winding, arduous route to approve traditional drugs, because variability of biology is less important when developing a physical treatment
So, NBTXR3 could be registered commercially for use in soft tissue sarcoma by end of 2016 (so long as it proves its worth in ongoing pivotal trials). That’s less than four years after the first pilot studies took place on 25 patients.
It is also worth noting that, as the product will be registered as a medical device, it will use the CE Mark scheme here in Europe to gain regulatory sign off.
“Our belief is what we are developing is less risky than a biotech because it is physics,” said Laurent Levy, chief executive and founder of Nanobiotix, when he spoke to Proactive.
“We have to spend a less money because the trials don’t involve thousands of people.
“Yet at the end the return on investment could be equal if not bigger than some of the drugs that come to the market.
“Remember, because this is physics we can target many, many patients.
“If you put all this together you come up with something for the investor that could be very, very interesting.”
The fine line between success and failure for businesses such as Nanobiotix is often not what happens in the lab, or in clinical trials – although failure here will be fatal. Access to capital, or lack of it, can also be terminal.
The company has done better than most of its peers in this regard. It raised 28mln euros to fund pivotal trials of its technology on 156 patients that should, hopefully, see it claim that coveted CE Mark.
It also completed a private placement that will fund its expansion into the US, the world’s largest medical market.
While it received an initial 10mln euros this could balloon to 35mln euros if things pan out as expected Stateside.
The company now has offices in Cambridge, Massachusetts, the hub for biotechnology and, crucially, nano-technology.
In going it alone in America Nanobiotix delays the point at which it brings in a commercial partner (if indeed it does), which will then allow it to maximise the value realised from its breakthrough technology in this important market.
The past year has seen the pace quicken for the Euronext-listed innovator, which has gone from being an early stage company to one now in the registration phase in Europe for soft tissue sarcoma.
A more extensive trial on 156 patients will report interim data in the middle of next year at which point the group will decide whether or not to go on a bridge study that would prime NBTXR3 for US Food and Drug Administration (FDA) registration .
This could be around a year after commercial sales begin in Europe and behind registration in Asia, where development is being carried out by Nanobiotix’s collaboration partner PharmaEngine.
As mentioned earlier, the firm has broadened the scope. A pilot study on 40 patients with head and neck cancer in Europe should be complete late this year, while a pilot on liver cancer will begin recruiting the first of 24 patients in the middle of 2015.
It has chosen the US to begin its pilot on prostate cancer patients.
“We have shifted from an early clinical stage company last year into one this year that is starting the registration phase in Europe,” said CEO Levy.
“We have been able to obtain the ’go’ from agencies to move forward for the registration phase quite fast and this first product in the market will be very important for us.
“When you put it all together: the size of the market, timing risk and money spent and assuming that the results are positive, you could have a very good return on investment equation. Now let’s continue to work to deliver results that should feed this equation.”