June 2017 | STOCKHEAD
Special report: The survival rate for bowel cancer is 90 per cent if it’s caught early. But people are reluctant to take stool tests — which results in more deaths. In 2015, 4346 Australians died from bowel cancer — the second-highest number of cancer deaths after lung cancer. More than 15,000 new cases are diagnosed in Australia each year.
Melbourne-based Rhythm Biosciences (ASX:RHY) is trying to change that with a simple mission: create a bowel cancer test that is simpler and more acceptable to the squeamish. That technology, now known as ColoSTAT, has come through the wringer of scientific testing all the way from a CSIRO preventative health movement in 2003.
Rhythm’s CEO and managing director Dr Trevor Lockett — who was there at the beginning — hopes the company’s recent $9 million IPO in December will take the technology from trials to regulatory approval in Europe and Australia within two years.
His main mission: saving lives.
Rhythm Chief Trevor Lockett
A bowel problem
People aged over 50 have a dramatically greater risk of developing bowel cancer. The initial screen for bowel cancer is a stool test — a faecal immune test that looks for blood in the faeces — but many people don’t like taking it. While there is a National Bowel Cancer Screening Program — and participation rates are increasing — only about 37 per cent of people offered the test actually complete it, Dr Lockett says.
This isn’t unique to Australia. In Europe, Australia and the US combined, over 250 million people should be screening for bowel cancer but over 130 million of these aren’t. Rhythm is making a blood test that is effective, affordable and, importantly, also able to be used in real-life settings — an important detail when you’re making a diagnostic test.
Dr Lockett was the “theme leader” for bowel cancer and gut health in the 2003 CSIRO plan. “We were trying to identify improved approaches to early detection of bowel cancer and diet and lifestyle approaches to its prevention,” he told Stockhead.
The blood test research was directed by CSIRO’s research group leader for Precision Health, associate professor Leah Cosgrove, who embarked on a 13-year journey to find and clinically validate a series of protein biomarkers that could identify bowel cancer efficiently, using literature research, hard science and machine learning.
Teaching the machines
ColoSTAT would not have been possible without the seamless collaboration between biologists and mathematicians. The biologists could find the biomarkers, while mathematicians knew how to make the data ‘speak’ via algorithms. “The machine learning helped us understand which biomarkers were most informative and what weighting to give those to get the most accurate results,” Dr Lockett said. “As we acquire more data, it will allow us to refine those algorithms to further improve performance.”
ColoSTAT uses antibodies to measure the levels of several proteins in the blood, the concentrations of which have been shown to vary in the presence or absence of colorectal cancer. And today they say a development program for biological reagents that test for these antibodies is on schedule. A suite of five mixed monoclonal antibody preparations have passed two out of three preliminary screening tests with the final screening test in progress, as conducted under the research contract with CSIRO.
Completion of the three tests triggers cloning of the cells required to produce the antibodies of interest for ColoSTAT. More detailed testing of these antibodies will follow to identify those most fit for the diagnostic purpose of ColoSTAT. Final testing is expected by the end of May 2018. Once identified, those antibody-producing cell lines will join those already in hand for the other two target biomarkers Rhythm has secured.
Protecting innovation with patents
By 2010, the scientists — still at CSIRO — had reduced the number of biomarkers they thought were likely candidates down from 68 to 10 and patented them and their application. The patent has been granted in China, Australia, Japan, and Europe, with applications still working their way through the US and India systems.
“A patent is useful for giving protection over sale and manufacture. While China and India are potentially huge markets in their own rights and of significant interest to Rhythm in the future they are both also very good at re-engineering things,” Dr Lockett said. “By having patent coverage in India, we believe we have the opportunity to ensure that we aren’t worked around in a country that can do that on a major scale and retain access to a future major market for our technology.”
With clinical studies confirming the technology had legs, in 2013 the team began talking to industry bodies about ways to leverage and commercialise this well-developed innovation. Grants from Australia’s peak health funding body the National Health and Medical Research Council and the Bupa Health Foundation allowed the team to compare their test against the faecal immune test (FIT), and to start making their own biological agents — until now they’d been using off-the- shelf versions designed for research only.
But it was talks with Planet Innovation in Melbourne, a health-tech innovation and commercialisation company with an interest in medical devices, that began the move towards the ASX. In 2015, Planet Innovation put them in touch with a group of people, including current company secretary Adrien Wing and director David White, who would spend two years performing due diligence on the technology and crafting a business plan for Rhythm.
Finally in the middle of 2017 they registered the company and the wholly-owned subsidiary Vision Tech Bio acquired the exclusive global licence to the technology underpinning ColoSTAT from CSIRO. The IPO was heavily over-subscribed. The shareholders list comprises a healthy mix of institutional and private investors with founders and board members prominent amongst them.
CSIRO is also a shareholder and still working closely with the company on ColoSTAT. Rhythm is planning to finish two more studies in the next two years, the last of which will be a 500-1000-patient trial in 2019 to assess the clinical performance. These will form an important part of dossiers supporting applications for a CE mark in Europe and for listing on the Australian Register of
Therapeutic Goods in Australia, due to be lodged late in 2019.
The board is well endowed with experience and expertise in the diagnostics sector. Shane Tanner, who cofounded Zenitas Healthcare and was CEO of Symbion Health, is chairman and Lou Panaccio, director of gargantuan diagnostic group Sonic Health and the ex-CEO of Melbourne Pathology and Monash IVF is a non-executive director.
This article was first written and published by Stockhead on June 2017, click here to visit their website.