Rhythm Biosciences completes cloning step of key reagent development ahead of schedule
- Monoclonal antibody-producing cell lines now isolated
- RHY moving to next stage of characterisation & expansion
21 June 2018, Melbourne: Medical diagnostics pioneer Rhythm Biosciences Limited (ASX: RHY) is pleased to announce that the next phase of key reagent development has been completed successfully and ahead of schedule.
Producing the reagents was a major technical achievement because it involved isolating four cell lines, each producing monoclonal antibodies which target the third biomarker on the lead diagnostic panel.
The success of this cloning is another critical step towards ensuring the company has a reliable, long-term source of key reagents for its simple and effective ColoSTATTM blood test for colorectal cancer.
RHY now enters a phase that entails detailed characterisation of the monoclonal antibodies produced by the cell lines. The Company expects this work to be completed by mid-August 2018.
Following this, RHY will characterise the growth and antibody production properties of the selected cell lines. This will lead to the commencement of expansion and biobanking of master (and working) cell banks of these critical cell lines, ensuring the company has a long-term, well characterised sustainable source of these important reagents.
The Company remains on track to have delivery of the key reagents and cell lines completed by late November 2018.
“The CSIRO and the Rhythm teams have worked hard and done an excellent job of screening and cloning these antibody-producing cell lines putting Rhythm in a strong position to develop quality assay kits for this the third biomarker of its lead ColoSTATTM biomarker panel,’’ said Rhythm CEO, Trevor Lockett
Dr Lockett said the team is focussed on seeing the fruits of their labour translated into robust laboratory tests that can be clinically evaluated in Study 6, currently on track to start in late calendar 2018.
“We are confident of the science behind this test and we are moving as fast as we can to progress it through the clinical testing phase,’’ said Dr Lockett.
This announcement follows earlier announcements on 12 June and 15 June that leading biotechnology investor Merchant Group’s Merchant Opportunities Fund had become a substantial shareholder in Rhythm, initially with a stake of 5.02 per cent of the company and later 7.01 per cent.
“Colorectal cancer is the third highest cause of cancer death world-wide yet it is quite treatable if diagnosed in the early stages so we really want to enable doctors to order a simple blood test as soon as we practically can,’’ Dr Lockett said. “In Europe, Australia and the US combined there are 250 million people between ages 50 and 75 years who should be screening for colorectal cancer but 130 million of these don’t.
Dr Lockett said once clinically proven and approved, Rhythm’s goal will be to make ColoSTAT™ an important tool in the diagnosis and treatment of colorectal cancer, augmenting existing tools such as the faecal immunochemical test (FIT) and colonoscopy. It’s all about getting more people screening and saving lives.
Colorectal cancer is a growing concern in Australia, United States and Europe
Colorectal cancer is currently the 2nd largest cause of cancer death in Australia, Europe (EU) and the United States (US), and the 3rd largest cause of cancer-related deaths globally.
The seriousness of the colorectal cancer problem and benefits of early detection have been recognised. A number of countries around the world have introduced screening programs targeted at reducing the morbidity, mortality and healthcare costs associated with colorectal cancer. In Australia for example, the National Bowel Cancer Screening Program was developed to detect colorectal cancer early to enable early intervention, improve treatment outcomes and rein in associated health costs with treating the disease in its later stages.
It’s estimated there are around 250 million people aged between 50 and 75 years for whom regular screening is recommended, yet the majority remain under-screened.
Early detection has the potential to improve treatment outcomes and save lives
Disease progression of colorectal cancer
Survival is highly dependent on how advanced the cancer is at time of diagnosis. At the earliest stage, cancerous lesions can be removed during a colonoscopy and survival rates can be 90% or even higher. Late stage treatment protocols become more invasive, are expensive and lengthy. Early detection and treatment of this disease increases treatment options and has the potential to save lives.
Patients with cancers at the earliest, most treatable stage of colorectal cancer, generally have no physical disease symptoms. These cancers bleed less, both in quantity and frequency, than more advanced cancers making them more difficult to detect with the most commonly used faecal screening test.
The risk of the cancer spreading increases progressively by stage. At each stage the cancer grows deeper into the layers of the bowel wall and beyond, increasing the risk of cancerous cells metastasizing. As the cancerous cells break away from the primary tumour they typically spread first to the lymph nodes, then to other target organs and tissues such as the liver, lungs, bones and brain.
At these later stages, the primary cancer is easier to detect with current laboratory diagnostic tools. But, the patients will often require more invasive treatments which may also include chemotherapy.
Many people between 50 – 74 years remain unscreened
The Faecal Immunochemical Test (FIT) is an inexpensive pre-assessment of colorectal cancer risk. This test looks for surrogate markers of cancer (blood in the faeces) to identify whether a colonoscopy is needed for a clear diagnosis and to initiate appropriate treatment.
This test is offered to people aged between 50 – 74 years in Australia and most of Europe. In the US, the recommended testing includes sigmoidoscopy and colonoscopy.
Despite the efforts of screening programs to date, out of approximately 250 million people between 50-74 years of age in Australia, EU and US, around 132 million people are not screened as recommended for colorectal cancer.
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The ColoSTAT™ technology has the potential to become the new, first step screening test for people, who for personal, cultural or clinical reasons, elect to not participate in the existing screening programs for colorectal cancer.
ColoSTAT™ is designed to be a simple blood test:
- Cost effective
- Minimally invasive
- Another option for those currently unwilling to screen
- Easily run by laboratories, with minimal training or need for new infrastructure
Comparable to, if not better than, the current FIT tests in detecting early stage colorectal cancers
The in-development ColoSTAT™ blood test is anticipated to achieve greater patient participation and compliance than faecal tests. It could also be used as a triage for FOBT/FIT positive results to prioritise urgency for colonoscopy follow-up.
The proposed ColoSTAT™ blood test has the potential to efficiently detect colorectal cancer at all stages, including the early ones. The test is to be an immunoassay – a biochemical test that measures the presence or concentration of multiple protein biomarkers for colorectal cancer.
This search for suitable biomarkers began in 2003. Since then, CSIRO scientists have identified 68 proteins reported to vary in concentration in the blood of patients with and without colorectal cancer.
Assisted by funding from the National Health and Medical Research Council, CSIRO evaluated these 68 biomarkers across five studies and reduced it to a lead panel of just a few. The studies found that when certain combinations of these protein biomarkers are measured in a blood sample, and their concentrations weighted using an algorithm, a colorectal cancer risk score can be determined. It is this patented process that forms the basis for the ColoSTAT™ technology.
Rhythm Biosciences is now working towards turning this technology into an in-market product.
ColoSTAT™ is designed to be minimally invasive, cost effective and provide another option for those currently unwilling or unable to participate in current screening programs, estimated to be over 100 million people just in Australia, Europe and the United States.
If patient participation can be improved, and early detection achieved as comparable to, if not better than, the standard faecal test, there is an opportunity to save lives and reduce the significant impact this disease.
Shane Tanner Chairman
An experienced, accomplished and highly-respected professional in the Australian Healthcare sector, Shane has orchestrated and been responsible for numerous small and large scale acquisitions. He also has helped to establish and guide a number of significant businesses where he was deeply involved in growth and management upskilling.
Shane has considerable experience at both senior executive and board level, being Chairman of ASX listed Paragon Care Limited and Zenitas Healthcare Limited, two successful healthcare businesses where he was the Co-Founder of each. Shane is also Chairman of ASX listed Funtastic Limited. Previously, Shane was CEO of Symbion Health (formerly Mayne Nickless Diagnostic Services), one of Australia’s largest diagnostic businesses, CFO of Mayne Group and Chairman of Vision Eye Institute.
Trevor Lockett CEO and Managing Director
A molecular biologist by trade, Trevor Lockett received his PhD in biochemistry from the University of Adelaide and postdoctoral experience at the Rockefeller University in New York. With over 30 years of research experience, predominantly at the CSIRO, Trevor has led large, multidisciplinary research efforts in the areas of prostate cancer gene therapy, colorectal cancer prevention and the promotion of gastrointestinal health. In his role as Theme Leader, Colorectal Cancer and Gut Health, Trevor oversaw the research efforts leading to the technology that is to become ColoSTAT™.
Trevor is an inventor of seven active patent families, all of which have been licensed. Trevor has previously served on the leadership executive team of business units within CSIRO and has a strong commitment to improving human health and wellbeing through the translation and commercialisation of scientific discovery into innovative products and services.
Lou Panaccio Non-Executive Director
A chartered accountant with extensive management experience in business and healthcare services. He is currently on the boards of ASX listed companies Sonic Healthcare Limited, Genera Biosystems Limited and Avita Medical Limited. Lou is also on the board of Unison Housing Limited.
Lou has more than twenty years’ experience as a board member of both public and private, for profit and not for profit companies. Previously, Lou was the CEO of Melbourne Pathology and Monash IVF, and also executive Chairman of Health Networks Australia.
David White Non-Executive Director
Based in the United States, David is a current Senior Consultant with Planet Innovation where he leads the business development efforts for the Lumos Diagnostics Division. David has over 18 years of in-depth experience covering strategic and tactical marketing, medical device sales and the commercialisation of diagnostic products.
David has previously spent three years as the Group Marketing Manager of Advanced Staining for Leica Biosystems based in Chicago. David orchestrated the integration and strategic growth of newly acquired Vision BioSystems products within Leica’s US business unit. This was followed by three years in molecular sales for GenMark Dx where he initially covered 11 states in the US Midwest and grew his start-up territory by over 100% year on year. David’s network and contacts within the US diagnostics market can accelerate the path to commercialisation in this key geography.