The five-year survival rate for prostate cancer is as high as 99% in some countries – but this is after the first diagnosis. If the disease comes back it can be far more aggressive, and it is crucial to locate the tumour as fast as possible. Blue Earth Diagnostics is developing an imaging tracer that it claims can do just this.
And, in a climate where many investors will only stump up if a company already has a product on the market, Blue Earth has managed to score £12.8m ($21.2m) funding from Syncona Partners despite its tracer being in phase II. “Syncona are not looking for a short-term exit, like many VCs are,” says Jonathan Allis, Blue Earth’s CEO. “They’re looking to set up sustainable businesses run for the long term.”
The imaging agent, called [18F]-fluciclovine, has been licensed in from GE Healthcare, the company for which Mr Allis used to work. He believes that Blue Earth is better suited to developing the product as it has a narrower focus. “This is quite a small opportunity. It’s a niche product which a small company can develop more rapidly than a big company – GE has 20 things to work on and we’ve got just one,” he says.
While prostate cancer is the most common cancer in men, fluciclovine remains a niche product as it is only suitable for imaging recurrent disease. “Primary prostate cancer is caught quite early and the cure rates are very high,” Mr Allis says. Recurrent disease, by contrast, can be much more dangerous.
Once a patient is clear of primary cancer, their levels of prostate-specific antigen (PSA) are monitored, and three consecutive rises will lead to the patient being sent for imaging – ultrasound, CT or MRI – to locate the new tumour. These “typically won’t find anything”, Mr Allis says. Since the location of the tumour or tumours is necessary for determining the best treatment, recurrent cancer patients often receive inappropriate therapy.
Around 35% of prostate cancer patients will experience recurring disease that is not detectable on conventional imaging. Fluciclovine, a synthetic amino acid preferentially taken up by prostate cancer cells, can pick it up when the patient undergoes positron emission tomography (PET), a relatively new and expensive form of imaging.
Blue Earth’s tracer is less suited to primary disease as PET is not markedly better than the cheaper imaging modalities in this context. “It’s sensitive, so you can see [the cancer], but it’s not specific so you can confuse it with a number of other prostate diseases, like benign hypertrophy or hyperplasia. But it is very, very specific in finding recurrent disease,” says Mr Allis.
The greater cost of PET becomes justifiable in the recurrent setting as the therapies are very expensive; eliminating false diagnoses will help save payers’ cash. “It makes sense economically,” Mr Allis says.
Regulated as a drug
Phase III trials of fluciclovine are likely to start soon, and Blue Earth is already gearing up for the approval process. “We’ve finished phase II. We’ve got meetings with regulators planned for the first half of this year. We would expect to start the final phase III study some time this year.” The phase III study will recruit “some hundreds of patients,” Mr Allis says, “from the US, Europe, and a few from Canada and Australia.
While PET scanners, like all imaging systems, are medical devices, the imaging agents used with them are regulated as pharmaceuticals, meaning that the approvals process will be longer than that for a device. Compared to true therapeutic drugs, though, it is slightly speedier, requiring smaller trials. There are fewer safety issues with tracers, particularly for PET agents, because very small quantities are injected.
Uptake of the imaging agent, if approval is granted, will rely on doctors having access to PET scanners, which are not as common as MRI or CT devices. Still, they are mostly used for imaging cancers, so most oncologists are familiar with PET.
There are between 4,500 and 5,000 PET scanners in use around in the world, with about 2,000 in the US and 1,000 in Europe – they are present in most large cancer centres. Use of fluciclovine “would slot quite well into the existing workflow,” Mr Allis says. “Scanner distribution is probably not a barrier to using this test.”
Intriguingly the company is not interested – yet, anyway – in expanding the market opportunity for the tracer. “There’s some published data suggesting that it has application in a few other small tumour types but our focus is all on prostate. We’re super focused,” says Mr Allis.
A compelling case
Syncona Partners is obviously convinced, ponying up for a company with a single mid-stage project at a time when even medtech companies with approved products are having difficulty drumming up funding (Innovation threatened as medtech sees no improvement in venture funding, January 29, 2014).
Having staff with experience at GE as company founders may well have helped Blue Earth’s funding case, but Mr Allis emphasises that the science is sound too. “We’ve got pretty good evidence that it works from the clinical studies we’ve done so far, though of course it still has to be proven in a large phase III trial. And most of the doctors we’ve worked with on this are very keen and want to continue to work with it. It’s a pretty compelling case – you’ve got a real unmet medical need, and a product that seems to work.”
Syncona is the venture arm of the Wellcome Trust and is clearly able to eschew a quick pay day in favour of something that might, over time, make a real difference to patients’ lives.
It is simultaneously reassuring to see a funder take a chance on a new company and worrying that it took a charity to do it.