While VolitionRx’s Nu.Q diagnostic blood tests are deceptively simple, their impact promises to be momentous.
The NYSE-listed company has designed a routine blood test to screen for colorectal and prostate cancers that reduces the need for more invasive colonoscopies and biopsies. It might also work as a screening tool for endometriosis and has potential veterinary uses as well.
“We can do a lot of good with what we’re doing,” says VolitionRx CEO Cameron Reynolds. “Now that we’ve done the background work we need to do with our blood assays, we’re very close to launching the different products for different cancers and diseases. I think people realize we have something very special. No one has really worked in nucleosomes in the way we have before.”
To consider VolitionRx as an investment play, one must look at the dazzling science behind its technology. At its command and control center in Isnes, Belgium, more than 30 scientists are conducting the background work necessary to introduce VolitionRx’s key Nu.Q blood tests to the public.
At the center of it is VolitionRx’s NuQ platform, which looks for molecular signatures of cancer by focusing on the nucleosomes – a section of DNA wrapped around a core of proteins – in the blood. As cancer cells multiply, they are modified in a way that distinguishes them from healthy cells and the traits of the malignant disease appear on the nucleosomes, which are analyzed by Nu.Q’s platform.
The first Nu.Q tests to detect colorectal cancer are likely to hit Europe by the end of next year, followed by Asia in 2020 and the US by 2021. But Reynolds says the company won’t see “serious” revenue until 2021 or 2022.
Volition tackles trials around the world
Currently, Volition is focused on research and development and the company is deep in clinical trials around the globe.
In one of its biggest successes to date, Volition announced in August preliminary data from an 84-patient study that showed its Nu.Q blood assay kits diagnosed men with aggressive prostate cancer with 94% accuracy. This was a remarkable result, as a number of current diagnostic exams are not able to distinguish with subtlety the severity of prostate cancer, Reynolds says.
“The trial was to prove could we show the aggressive forms of prostate cancer from the non-aggressive ones and the results were excellent,” Reynolds says.
“The trial was statistically significant, but it was under 100 patients,” he adds. “So, now we’re in the process of trying to organize very large trials in prostate cancer because that’s a product that would be tremendously useful clinically.”
As its work in prostate cancer gathers pace, the management team at VolitionRx is also charging ahead in running trials for colorectal cancer at the same time.
In the US, Volition is taking part in what is believed to be the largest-ever colorectal cancer screening study in collaboration with the National Cancer Institute’s Early Detection Research Network.
Data is being collected from over 13,500 people in the US, a project that is set to be completed in 2020.
The collection of a European study involving the evaluation of 4,500 people with 27 of the most prevalent cancers at the University of Bonn in Germany, has also finished. And earlier this year, Volition signed agreements with National Taiwan University to conduct two large-scale colorectal studies across Asia.
“We’re getting to the stage where we’re almost ready to finish those large product trials – for triage and for front-line colorectal tests in Europe,” reports Reynolds. “And we expect to finish them in Asia in 2020 and in the US in early 2021.”
Other diseases and veterinary work beckon
But the company is also migrating far beyond its primary line of work in cancer detection. In its sights are the painful ovarian disease endometriosis, where it is collaborating with the University of Oxford to see whether Nu.Q blood-based tests can be used for diagnosis. While Reynolds is unsure whether the same technology can be used on endometriosis, it’s worth a shot.
It’s also pushing into veterinary medicine and pursuing a tie-up with Texas A&M’s College of Veterinary Medicine & Biomedical Science after discovering that nucleosomes in the blood can also be detected in dogs. “We’re seeing very promising results in veterinary uses,” reports Reynolds.
”Dogs are obviously different to humans in what’s important. We’re relying on consultants and experts including Texas A&M to really help us with that.”
The promise of the science draws investors
The prospect of a routine blood test that can replace expensive and invasive procedures like colonoscopies and biopsies is drawing substantial investor interest, including from European government agencies as well as the Walloon Regional government, which oversees the French-speaking region of southern Belgium where the company’s Research & Development facility is based.
As is the case with companies at this formative stage of their development, Volition saw losses of $4.6 million in the second quarter.
But over the summer, a shareholder committed to invest $9 million, adding to the $11.9 million the company already had in cash on hand at the close of June. “That makes over $20 million, which gives us a lot of runway,” Reynolds says.
The company has also entered into a sales and distribution partnership with another life sciences group, Active Motif, that has paved the way for a sale of research-only kits based on its Nucleosomics technology.
The kits cost $500 to $1,000, but if the buyer discovers something interesting in the blood assays, they must return to Volition for product licenses, another potential revenue generator. “The basic idea is to get the kits out there and to get them to as many groups, organizations and universities as possible and to really make sure our technology is being used as widely as possible.”
READ: VolitionRx's Nu.Q blood-based diagnostic tests offer great potential, says Oppenheimer analyst
Reynolds, an Australian with a commerce degree and an MBA from the University of Western Australia, set up Volition in 2010 while living in Singapore. Indeed, the company owes much of its achievements to the now-defunct UK biotech Chroma Therapeutics, whose scientists first demonstrated that cancer could be detected in a blood test by measuring nucleosomes containing chemically-modified histone proteins. While in Asia, the company’s technology drew the attention of Reynolds, who applied his business acumen, recruited its staff and eventually went on to acquire its patents.
Since starting off as a fledgling idea, Volition, which floated on the NYSE in 2015, has evolved into a business with considerable international reach that may well one day radically transform the way doctors screen for various cancers.
Its team includes Dr Alan Colman who was formerly the research director at PPL Therapeutics, the Scottish company involved in funding the cloning of Dolly the Sheep and chief scientific officer Jake Micallef who previously worked for Chroma as well as the World Health Organization and the NHS in the UK. Dr Jorge Reis-Filho, the director of experimental pathology at the Memorial Sloan Kettering Cancer center in New York also sits on its scientific advisory board.
Partnerships with governments ahead
Reynolds is confident that VolitionRx’s scientific achievements will translate soon into a sound commercial proposition. As early as next year, the company is aiming to partner with European governments to introduce triage tests, which would rely on Nu.Q tests to weed out people who are less likely to have colon cancer.
The company also wants to target the tens of millions of people who decline colonoscopies. “It’s hard to beat a technician with a camera and until we are as accurate as a colonoscopy, we absolutely will go for the non-compliant market,” says Reynolds. “It’s a huge market. … almost 30 million Americans are not up-to-date with their screening – a simple blood test could change that.”
It is the science being conducted at Volition’s 20,000 square foot facility in Isnes that has put the company on the path to success, with governments and the private sector in colorectal, prostate and veterinary screenings, each potentially multi-billion-dollar markets. And while Reynolds might be a businessman by training, this job has made him an idealist.
“The work has to be done and it has to be done right,” he concludes. “It’s taken time to do things properly and robustly, but it’s all coming to fruition now. We want to save lives.”
Contact Ellen Kelleher at [email protected]