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Twenty-two

James McIlroy - EnteroBiotix

Gut feeling proves right for EnteroBiotix…

James McIlroy - EnteroBiotix

Gut feeling proves right for EnteroBiotix

Just over one year after setting up in Aberdeen, EnteroBiotix stands on the brink of a major advance in the pharmaceutical industry, establishing the business as a leading global player in a multi-billion-dollar market, thanks to recent breakthroughs in a new branch of medicine – using the microbial communities found in the gut to prevent and treat a wide range of infections and diseases. To make such an impact so quickly in such a competitive field is all the more remarkable because the Founder & CEO, James McIlroy, was until very recently a full-time medical student...

Late one night four years ago, soon after he had started a degree in physiology at the University of Edinburgh, James McIlroy was browsing through some medical journals when he came across an article which changed his life forever – and could also help to change the world of medicine. Researchers had transplanted faecal matter from a lean mouse to an obese mouse, and the obese mouse lost weight. “It seemed like an amazing idea,” says McIlroy, recalling the moment of truth. “I realised that this could be the answer to all sorts of medical problems, but no-one was talking about it at medical school – the science was still very new.”

McIlroy then read another article describing how researchers in the Netherlands had done a stool transplant from one human into another, and the idea started gathering momentum. Surely, he wondered, there were other less invasive, more efficient ways to deliver the bacteria – for example, in a capsule that people can easily swallow? He also wondered if it would be possible one day to identify the”active ingredients” in the stool samples so these could be manufactured to get rid of the need for stool donations altogether.

Four years later, Dr McIlroy, now a qualified medical doctor, is CEO of EnteroBiotix, a company which raised £500,000 in funding within its first year and is on course to become a leading player in the pharmaceutical industry by developing new therapeutic products from the healthy bacteria which live in our gut – what scientists call the microbiome or microbiota. And the market for such products is expected to be worth over $2.2 billion by 2025.

Many infections or diseases are associated (causative or correlative) with imbalances of bacteria in the gut, and to restore the balance, doctors use antibiotics to reduce the bad bacteria or increase good bacteria with probiotics. In recent years, faecal microbiota transplantation (FMT) – transferring good bacteria from healthy people via rectal enema, colonoscopy, nasogastric tube or nasoduodenal tube – has proved to be particularly effective in the treatment of infections caused by Clostroides difficile (C. diff). And this is where EnteroBiotix is aiming to change things by developing a new kind of orally administered, patient-friendly product “with an increased product shelf-life”, which removes the need for invasive procedures while also “simplifying the design of placebo-controlled clinical trials.” And to bring this product into the healthcare system, EnteroBiotix has established an ISO-accredited controlled donation facility and manufacturing facility, with specialist technology–and specialist staff.

Inspiration

What inspires EnteroBiotix and McIlroy, who founded the company in 2017, is the potential of the gut or microbiome to prevent and cure a wide range of infections and diseases, by collecting faecal matter and delivering it as a treatment for patients, “making therapeutic products derived from healthy, tested and qualified donor microbiota that meet the requirements of competent authorities and guidance legislation in relation to medicinal products.”

This means taking stools from healthy, pre-screened human donors, then processing the good bacteria so they are easy and safe to transfer to a patient. Initially, the target for EnteroBiotix is infections caused by C.diff, but in the long term, this will be extended to more complex diseases, with an emphasis on inflammatory diseases and other infections.

Even though bacteria do not present the same compatibility problems as blood and can be safely transplanted from one person to any other, the company is also working with a network of collaborators “to generate datasets from studies where the microbiome is being manipulated to identify useful associations between microbial signatures and clinical response.” In other words, they want to find out if the same bacteria produce positive responses in certain diseases.

Three steps forward

EnteroBiotix has conceived a three-pronged strategy to take it to the next stage of development. The first step is to bring its new medicinal products to market, using its new specialist equipment, including a cleanroom with isolator technology and dedicated quality control areas, based in the Rowett Institute for Nutrition and Health in Aberdeen.

The second step is to deliver its products for clinical trials, so researchers can identify and isolate the active ingredients to develop more targeted products by reverse-engineering individual components which mimic the effects of the bacteria. “This will play a pivotal role in the future,” says McIlroy, “by analysing how the gut reacts to therapy.”

The most exciting step, says McIlroy, is when EnteroBiotix will “super-charge” bacteria to target specific diseases. “This is where our impact will be greatest,” he explains, “by enhancing our products to optimise their therapeutic effects, by adding bacteria or specific microbial compounds. We want to be the very best in the world at augmenting human-derived donations for therapeutic application.”

In the early stages of developing new therapeutic solutions based on microbiota, it is hard to patent any of the products because they're based on natural ingredients and hard to differentiate, but when the company begins to make its “super-charged” products, that will change the game completely, as the know-how increases and the products are uniquely formulated – not just a full microbial community, but more defined “consortia” that deal with different medical problems affected by the balance of bacteria.

In years to come, according to many researchers, the microbiome could provide therapeutic solutions for everything from motor neurone disease to depression. Already, says McIlroy, studies of mice have revealed a connection between bacteria and Parkinson’s disease, and he is confident that many inflammatory diseases such as ulcerative colitis and Irritable Bowel Syndrome (IBS) may soon be treated using products based on good bacteria. Mental health may also be a target in future – the gut is known to have a big effect on the brain and is even described as “the second brain” by some researchers, part of what is called the “gut–brain axis.”

The other long-term aim, says McIlroy, is “to develop a fully integrated functional metagenomic platform for developing novel therapeutic candidates targeted at the microbiome,” as EnteroBiotix evolves into a microbiome pharmaceutical company, equipped with all the components it needs to become a world-class player
in the industry, taking advantage of the latest advances in bioinformatics.

Ultimately, this may lead to future innovations which may eliminate the need for FMT altogether. “It may be that, for some diseases, a whole community approach is optimal. However, in others, it may be that the same or an improved effect could be achieved by defined ‘cocktails’ of bacteria or the molecules that they produce,” says McIlroy, adding: “reverse engineering will have a huge impact in future by developing novel solutions and we are uniquely placed with our integrated collection and manufacturing platform to partner with other companies with data science and sequencing capabilities”.

Rapid progress

In its first year, EnteroBiotix won significant investment (oversubscribed) from a group led by Equity Gap, supported by the Scottish Investment Bank, the investment arm of Scottish Enterprise. The money (£500,000) has been used to “develop the first orally available products for FMT in Europe” as well as to expand the manufacturing and research team – the current staff of nine is expected to increase to over 20 people during the next 12 months.

Since setting up the company, McIlroy has also won a number of awards, including being named one of the Ten Outstanding Young People in Scotland by Junior Chamber International and Emerging Entrepreneur of the Year by Business Quarter, the Herald Scotland Global Game Changers award for ‘Young Pioneers’ and the Scottish Institute for Enterprise Young Innovators Challenge; while EnteroBiotix also came first in the 2017 Oxford Biostars biotechnology competition.

As the company prepares for its next round of investment, McIlroy knows there is still lots of work to be done. For someone who has just graduated from medical school – with distinction – after doing 12-hour shifts in hospitals and studying for his final exams at the same time as running his business, hard graft should not be a problem, however. McIlroy has an unwavering drive to succeed, but like so many other successful entrepreneurs, he also has a talent for attracting investors as well as the professionals he needs to turn his ideas into products – and profits.

McIlroy confesses that he has very limited experience in clinical medicine or working in laboratories, but he was also quick to recognise such talent would be critical to building his business and making his vision come true. One of the first professionals to join him was Nicolas Robinson, who has over 20 years of experience in cellular therapies and the manufacture of medicinal products and previously held a senior post in the Aberdeen Blood Transfusion Centre. Now Production Manager, Robinson had to be persuaded to cancel his plans for retirement to join EnteroBiotix. Among the other early recruits was Christopher Mosedale, the Research and Innovation Manager, a former medical student with a long-standing interest in the microbiome who also worked for EuroBiotix, McIlroy's initial venture into biotechnology, and Gregor Russell, the Chief Operating Officer, who previously worked with McIlroy as Director of Commercialisation at Innova Partnerships. McIlroy has also recently recruited Dr James Clark as the company’s new CEO. Clark was formerly the CTO at Enterome, a Paris-based microbiome company that recently raised £30 million in funding. “With these skilled hands on deck I am confident that we will launch our rocket ship into orbit over the next few months,” says McIlroy.

The early days of EnteroBiotix were a “whirlwind of activity” for McIlroy, but he also recognised he needed solid industry know-how at the core of the new operation, and persuaded Colin Christopher Bennett to come aboard as Non-Executive Chairman, not just for his experience in the oil and gas sector but also as the Chief Executive of Benenden Health and his knowledge of governance issues.

It's difficult to know all the technical details of developing novel medicinal products as well as learning how to run a business, becoming a doctor and doing a degree in physiology during a so-called “year off” in Edinburgh, but McIlroy's job is not just to put in the hours in the lab and recruit experienced people but to articulate the corporate vision – “a patient-centred biotechnology company focused on developing first-in-class medicinal products for use in currently unmet clinical needs.”

McIlroy also believes that “the microbiome is the next big frontier of medicine,” and that EnteroBiotix and its partners “must work together to improve the lives of patients through sound science and pioneering medicines.” The company website also describes the need for close collaboration and innovation: “We know that in order to achieve our mission we must form alliances and create partnerships, and embrace innovation throughout our supply chain.” A recent agreement with NHS Tayside is one good example of how EnteroBiotix can partner with healthcare providers to demonstrate the benefits of innovative microbiome products, at the same time as “catalysing and accelerating product development.” The company has also signed agreements with the Scottish National Blood Transfusion Service and the Rowett Institute.

Social enterprise

When McIlroy was first inspired to set up a company to develop microbiome-based solutions, he thought the best approach would be to form a social enterprise, not just a company which aimed to make the world a better place but an organisation which did not pay a dividend to any investors – what he calls an “asset-locked” business. In November 2014, he set up a social enterprise called EuroBiotix CIC, “to expand safe access to FMT across the NHS.” As time went by, however, he realised this model was not the best way to deliver results at the scale he desired to achieve. To create new medicinal products for large populations and major clients such as the NHS, he not only needed world-class technical help but also committed investors. Winning an RSE Enterprise Fellowship in September 2016 was another “pivotal moment” which helped McIlroy gain more perspective on business, as well as providing financial support. Having benefited from business training himself, McIlroy is also keen to help set up fellowships for medical students, to develop their entrepreneurial skills, and he was recently appointed Honorary Lecturer in Healthcare Innovation by the University of Aberdeen. “My plan is to leverage this appointment to forge new paths for entrepreneurial medics in partnership with existing resources at the University and beyond,” he explains.

“Big ideas need big money and big ambition behind them to succeed,” he says. “The most important thing is impact and the ethos of the organisation. The legal structure is a secondary issue. I’m passionate about translating ideas into products that will benefit society. EnteroBiotix embodies all the same values as a social enterprise, and we are still razor-focused on impact, both for the individual patient and healthcare providers in general. We want to help people get easier access to medical treatments, and that requires significant investment.”

McIlroy has always wanted to do “something big” with his life and make a contribution to society. When he is pitching to investors, he tells them he wants to do something that benefits people, but he also knows the company must be sustainable over the long term, as well as “putting patients at the heart of everything we do.” And if that means EnteroBiotix emerges as a world-class pharmaceutical company, creating all-round benefits for everyone, his stakeholders will not complain.


The manufacturing challenge

To deliver safe, effective pharmaceutical solutions, companies such as EnteroBiotix have to meet the highest manufacturing standards. One basic problem is that the donated microbiota are exposed to the external environment, and this requires the use of strict aseptic techniques and specialist controlled environments such as biosafety cabinets and cleanrooms. Another challenge is that most microbiota are anaerobic bacteria (do not need oxygen to grow and may even die when exposed to the air), and traditional manufacturing methods involve open systems and aerobic environments which could compromise the viability of therapeutically-active anaerobic bacteria.

To solve these challenges, EnteroBiotix has developed a semi-automated ‘closed system’ that maintains the critical quality attributes of the microbiota – so the company in future will be able to enhance microbiota by adding and/or removing strains of bacteria in a more precise, and more controlled, manner.

 

 

 

 

"James McIlroy - EnteroBiotix". Science Scotland (Issue Twenty-two)
Printed from http://www.sciencescotland.org/feature.php?id=346 on 19/11/18 06:31:01 PM

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