Review

A scientific generation corporate founded in Australia, Cleo Diagnostics (ASX:COV) is revolutionising girls’s healthcare with its disruptive most cancers detection platform generation, via a easy blood examine that may as it should be hit upon ovarian most cancers early – the main reason behind cancer-related deaths amongst girls.

Roughly 50 % of girls will die inside 5 years of an ovarian most cancers prognosis. The probabilities of survival past 5 years, then again, build up with early detection. In keeping with the American Most cancers Society, handiest about 20 % of ovarian cancers are recognized at an early level, and greater than 90 % of girls reside past 5 years when the most cancers is detected early.

With early prognosis being key to a better survival price, ovarian most cancers has turn out to be a goal for biomarker analysis. And one specific biomarker holds promise.

Cleo’s generation is underpinned via the CXCL10 novel and patented biomarker, which was once first recognized as a small inflammatory molecule in ovarian most cancers tissue sections. Next analysis demonstrated that CXCL10 was once overexpressed in ovarian cancers, however importantly no longer expressed in benign illness, and stays all over the life of the most cancers. The biomarker successfully supplies a powerful indicator in any respect phases of most cancers. Spotting that early detection is a considerably unmet want within the scientific diagnostics marketplace, Cleo Diagnostics is excited by bringing to marketplace a easy blood examine to as it should be hit upon ovarian most cancers early.

The addressable marketplace for a generation like that is compelling, and with a control group that brings to the desk a long time of management enjoy within the scientific generation house, Cleo is well-positioned to leverage this marketplace alternative.

Cleo leader govt and govt director Dr. Richard Allman has over 30 years of enjoy in commercially centered medical analysis and innovation. Over the process his profession, Allman has overseen and expedited a product construction pipeline overlaying at least six main cancers, heart problems, type-2 diabetes and a commercially to be had COVID-19 examine.

Leader medical officer Dr. Andrew Stephens boasts an similarly spectacular resume. A profession analysis scientist with twenty years of enjoy in molecular and mobile biology, Stephens is known as in over 60 educational publications and holds a large number of patents within the most cancers treatment and diagnostic house. Cleo’s blood examine seems to be for a unique and patented biomarker within the blood known as CXCL10, which was once came upon via Stephens, the made of over ten years of medical paintings at Monash Clinical Centre’s Hudson Institute of Clinical Analysis.

There may be additionally Professor Tom Jobling, Cleo’s non-executive director and scientific consultant. As the pinnacle of gynaecological oncology at Monash Well being and visiting scientific officer on the Peter MacCallum Most cancers Centre, Jobling has been treating ovarian most cancers for over thirty years. He was once additionally the founding Chairman of the Ovarian Most cancers Analysis Basis (OCRF)

Non-executive director Lucinda Nolan, in the meantime, brings important industry and strategic experience to the desk. Maximum lately, she served because the CEO of the Ovarian Most cancers Analysis Basis.

Those skilled pros, along with the opposite individuals of Cleo’s control and board, have advanced a staged execution technique excited by de-risking the pathway to the global screening marketplace — making sure that, even supposing Cleo remains to be in its complicated R&D level, its possibilities for commercialisation stay extremely promising.

Corporate Highlights

• Subsidized via scientific pros and most cancers consultants with a long time of enjoy, Cleo Diagnostics has advanced a disruptive, correct and early-stage ovarian most cancers detection blood examine.
• Cleo goals the CXCL10 novel biomarker, which is referred to now to be overexpressed in all phases of ovarian most cancers.
• Cleo is the results of greater than a decade of analysis on the Hudson Institute of Clinical Analysis, the place leader scientist Dr. Andrew Stephens gained greater than $5 million OCRF & NHMRC investment for construction and scientific research.
• The examine could also be supported via Professor Tom Jobling, founding father of the Ovarian Most cancers Basis and Lucinda Nolan, the root’s former CEO.
• Cleo has advanced a staged execution technique excited by an achievable trail to marketplace. This guarantees the mission, which is recently in its complicated R&D level, can maximise business price for all stakeholders.

Evolved over the process a decade via Dr. Andrew Stephens, Cleo’s blood examine is underpinned via the CXCL10 novel and patented protein biomarker recognized to be found in all phases of ovarian most cancers. By way of combining CXCL10 with a number of different biomarkers in a customized set of rules, Cleo can’t handiest be utilized in triage, but additionally for the needs of screening and recurrence checking out. The mission is recently within the complicated R&D level and has to this point performed two scientific research, analysing greater than 700 affected person samples within the procedure.

Highlights:

• Readily Obtainable: Cleo calls for no further or specialized apparatus and can also be performed in any same old pathology lab both by itself or as a part of a typical panel of assessments ordered via a health care provider.
• AI-based Possibility Evaluation: As soon as the pattern has been accrued and examined, Cleo leverages a proprietary set of rules to accomplish a menace analysis at the affected person, figuring out the chance of a most cancers prognosis.
• Intuitive Effects: Cleo generates an easy-to-understand post-assessment document which will then be despatched to the affected person’s number one care supplier or surgeon for triage.
• Top Efficiency: The Cleo prototype outperforms FDA-cleared predicates and scientific tenet assessments when it comes to accuracy and specificity.
• Present Roadmap: Cleo plans for the examine to be in a position for scientific use in a surgical triage environment via 2025, the place it’ll be to be had first of all to 1,000,000 sufferers. Goal release dates for recurrence, high-risk screening and mass screening are nonetheless to be decided. Moreover, the corporate has a large number of inflection issues deliberate over the following two years:
  • Equipment Building:
    • Interior trial antibody optimisation
    • Finalisation of antibody variety for the Cleo test-kit
    • Entire re-agent construction
    • Pre-IDE strategic construction
  • Production:
    • Established order and accreditation of ISO13485 high quality device
    • Production status quo of Cleo key biomarker
    • Production status quo of Cleo Ovarian Most cancers Equipment
  • Medical Research:
    • Signal key opinion leaders and trial websites
    • Carry out and finalise verification of the Cleo package via scientific research
  • Regulatory Approval:
    • FDA Pre-IDE submission
    • CE regulatory submissions and approval
    • TGA regulatory submission and approval
    • FDA submission and approval

Control Crew

Dr. Richard Allman — Leader Govt Officer and Govt Director

Dr. Richard Allman has over 30 years of medical analysis management and innovation with a transparent center of attention on commercialisation. He has vast enjoy in analysis management, innovation control, and highbrow belongings technique, overlaying oncology, diagnostics, and product construction.

In the past, Allman was once leader medical officer at Genetic Applied sciences (ASX:GTG). Fresh successes come with the strategic design and control of a second-generation breast most cancers menace evaluation examine from thought to business release and a identical examine for colorectal most cancers. Those assessments have now been NATA-accredited and include the primary commercially to be had polygenic menace assessments in Australia.

Extra lately, Allman supervised the underlying R&D, translation, regulatory approval, patent submitting and business release of a COVID-19 illness severity examine inside a 12-month length. This technique has been utilised to expedite a product construction pipeline overlaying six main cancers, heart problems and type-2 diabetes which have been commercially introduced in March 2022.

Dr. Andrew Stephens — Leader Medical Officer and Govt Director

Dr. Andrew Stephens is a profession analysis scientist with two decades of enjoy in molecular and mobile biology analysis. He has wide enjoy in educational and pre-clinical analysis and a powerful center of attention on translation and the commercialisation of analysis findings. He established and leads an impartial educational analysis crew on the Hudson Institute of Clinical Analysis, investigating mechanisms that give a contribution to the formation, development and dissemination of excessive grade, serous epithelial ovarian cancers. Since 2010, his analysis has excited by biomarker identity and construction in ovarian most cancers and the advance of healing methods to support affected person results. He’s additionally actively concerned around the biotech sector, with appointments to the medical advisory for Invion and AMTBio.

Stephens has greater than 60 educational publications and a large number of patents (pending and provisional) within the most cancers healing and diagnostic house.

Professor Tom Jobling — Lead Clinical Marketing consultant and Non-executive Director

Professor Thomas Jobling is director of gynaecologic oncology at Monash Clinical Centre. He graduated from Monash College in 1980 and did his postgraduate sub-specialist coaching in gynaecologic oncology in London on the Royal Marsden and St Bartholomew’s hospitals. Jobling has due to this fact been elected as a member of the Society of Pelvic Surgeons and could also be founding father of the Ovarian Most cancers Analysis Basis (1999). He was once the chairman of the Ovarian Most cancers Analysis Basis Board. His main pursuits are in radical surgical treatment for ovarian most cancers and the appliance of robot surgical treatment for gynaecological malignancy.

Jobling is an energetic member of a analysis group in biomarker detection and proteomics in ovarian most cancers. He’s concerned as a collaborative investigator on various global scientific trials and is a member of the Australia and New Zealand Gynaecologic Oncology Staff, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Staff and the Global Society of Gynaecological Most cancers.

Lucinda Nolan — Non-executive Director

Lucinda Nolan is a non-executive director and was once maximum lately the CEO of the Ovarian Most cancers Analysis Basis. She has a wealth of information and enjoy around the public sector and not-for-profit environments. Previous to becoming a member of the Ovarian Most cancers Analysis Basis, she was once decided on as the primary feminine CEO of the Nation Fireplace Authority, probably the most global’s biggest volunteer-based emergency products and services organisations. She additionally spent 32 years with Victoria Police, attaining the rank of deputy commissioner. She was once awarded the Australian Police Medal in 2009.

Nolan could also be the chair of BankVic and a director at the forums of Alkira Field Hill and the Melbourne Archdiocese of Catholic Colleges. She has a Grasp of Arts and a Bachelor of Arts (Honours) from Melbourne College and is an alum of the Complex Control Programme at Harvard College.

Adrien Wing — Non-executive Chair

Adrien Wing started his skilled profession practicing within the audit and company advisory divisions of a chartered accounting company. He has over 25 years of enjoy within the company sector with a big portion of this enjoy in ASX small caps, lead in IPO transactions and publish checklist opposite takeovers and acquisitions throughout a variety of business sectors and jurisdictions. He additionally has a powerful pedigree within the lifestyles sciences business being the founding father of Rhythm Biosciences and bringing that entity to the ASX in 2017.

Wing recently serves as an officer/director at the following corporate forums: New Age Exploration (ASX: NAE), director and joint corporate secretary; Purple Sky Power (ASX:ROG), director and joint corporate secretary; Sparc Applied sciences (ASX:SPN), corporate secretary; and Osmond Sources (ASX:OSM), corporate secretary.