Platform’s potential for early-stage detection cannot be ignored

Published on: 19 Feb 2018, under Breath Biopsy

Our CEO Billy Boyle was interviewed by thepharmaletter.  You can read the article below.

Platform’s potential for early-stage detection cannot be ignored, says Owlstone Medical CEO

By Guy Martin
Feb 16, 2018

Sometimes a device or diagnostic comes along that even the most drug-centric of pharma companies cannot afford to ignore, but when this innovation threatens to establish a new diagnostic modality that sits alongside blood and urine, it is definitely worth taking notice.

Pharma needs to be aware of Owlstone Medical’s Breath Biopsy platform, a non-invasive system that captures and analyzes breath samples for the presence of trace chemicals related to disease activity, not just because of opportunities for pairing patients with appropriate therapies. The system could also go a long way to cutting out the need for some of the very therapies that pharma’s billions are riding on.
“Ultimately the thing that we need to do in cancer is to get better at early detection”

The UK-based company already has a head-start – in terms of both having a starting point financially and proving the platform’s value – having developed it initially for military applications based on the core technology of detection of volatile chemicals, when chief executive and founder Billy Boyle (pictured above), along with a couple of other researchers, spun the company out of the University of Cambridge in 2004, using the name Owlstone.
After that, some $71 million has gone into the platform, with the US military becoming a major customer as it won $25 million in defense contracts.
Since it was possible to program in software, Mr Boyle and his colleagues had often said that they had an interest in potential medical applications, and so they spun out a business to focus entirely on this in March 2016. That was the birth of Owlstone Medical, and its Breath Biopsy has already won a series of awards for the promise that it is showing.

Mr Boyle recalls: We said: “What we’ve done before works so it’s applying it in a different market.” We looked at what were some of the challenges in breath – people have been trying it for a long time, actually – and the sceptic in me thought: “If it’s so great, why is it not in use in the clinic today?”
“There were some basic challenges that hadn’t been solved – you need to get the right sample or you’re going to get the wrong answer, irrespective of the technology that you use. And then there’s different types of technology you need, and discovery versus translational use, and then there’s getting clinical evidence – running large enough trials that get you to clinical evidence that shows you there’s something there that has utility.
“The benefit that we had operating initially as a division within the main business before spinning out was that it gave us time to understand the challenges, and solve them and then say: “Right, this is worth looking at in a more meaningful way, but in order to fund trials, we need to raise fresh investment and the direction we’re taking the business in is different, so that’s why we spun it out as a separate entity.”

Developing a medical focus

Since spinning out, the company has raised $23.5 million and has been largely focused on early detection of cancer, particularly lung cancer in which it is running the LuCID study. The trial will recruit up to 4,000 patients across Europe at 26 clinical sites, making it the world’s largest breath-based study ever undertaken for early cancer detection.

But lung cancer is just one area where the company could be focusing its attention.
“The reality is that the volatiles you see on breath can be helpful in diagnosis of other diseases such as infectious and inflammatory diseases, but also in helping to understand who is going to be a responder to particular therapies, and right through to thinking what are these chemicals – some are from body metabolites but some of them are drug metabolites – if you take a drug, in the same way you drink booze, it comes out in breath. That’s why a breathalyzer works.”

One area that that the company is working with partners – both in academia and pharma – is in essentially leasing its hardware for studies so that samples can be sent back to Owlstone Medical, which processes them in its breath biopsy lab. UK drugmaker GlaxoSmithKline (LSE: GSK) is one of the collaborators announced so far, having integrated Breath Biopsy into a Phase II respiratory disease trial.
Given that the core technology is well established and the lack of hurdles such as tolerability, the Breath Biopsy platform offers a non-invasive way of helping researchers get answers to some of the questions that they want. It is highly useful for those seeking to develop breath-based biomarkers for their own applications.

But does that use justify the company’s highly ambitious aim of saving 100,000 lives and $1.5 billion in healthcare costs?
That is where the potentially yet more impactful use of this breathalyzer comes in – to detect disease earlier.

Finding the ‘north star’ of the business

“If you look at something like lung cancer, there’s a very simple arithmetic logic – if you detect more cases earlier, you will save lives,” Mr Boyle says.
Doing something about this provided what Mr Boyle calls the ‘north star’ of the business.
“That’s why we fund programs in early detection,” he says. “And they’re hard, these are big trials, they take time, you need a lot of cash to run them. But ultimately we think it’s the thing that we need to do in cancer, we need to get better at early detection.”

Owlstone Medical is currently developing tests for colorectal cancer as well as lung cancer, and for asthma stratification by therapeutic response.
Outside interest in what the company is doing in this area is not coming from pharma. Perhaps not suprisingly, the insurance company Aviva is interested, and its venture capital arm has become an investor.

“If you look at curative cases, more often than not it’s surgery and radiotherapy that save patients,” Mr Boyle says. “With colorectal cancer, if you pick it up at stage one, 95% of people are going to survive because you chop it out.

“I think that’s why we have got the interest that we have got from partners like the National Health Service and Cancer Research UK – they’re asking: “do we need to have a new therapy for a patient that has stage four disease?” Well, not really because that’s going to extend life, it’s not going to cure it in the long term. You need a stage shift, and the big beneficiary from that is the patient and the healthcare systems because they’re the ones that ultimately pay from a monetary standpoint for late diagnosis.”

If Breath Biopsy is able to deliver diagnosis earlier in areas like cancer, then drugmakers too will need to react, as the need for late-stage drugs could eventually decline.

“We spend globally a trillion dollars a year on drugs and 40% of them don’t work for patients,” Mr Boyle says. “If you think about healthcare as a total continuum, we need to be thinking about early detection, prevention and interception as part of that overall strategy.”

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