Overview
A medical expertise firm based mostly in Australia, Cleo Diagnostics (ASX:COV) is revolutionising ladies’s healthcare with its disruptive most cancers detection platform expertise, by a easy blood check that may precisely detect ovarian most cancers early – the main reason behind cancer-related deaths amongst ladies.
Roughly 50 p.c of ladies will die inside 5 years of an ovarian most cancers prognosis. The possibilities of survival past 5 years, nevertheless, improve with early detection. In line with the American Most cancers Society, solely about 20 p.c of ovarian cancers are recognized at an early stage, and greater than 90 p.c of ladies stay past 5 years when the most cancers is detected early.
With early prognosis being key to the next survival charge, ovarian most cancers has change into a goal for biomarker analysis. And one specific biomarker holds promise.
Cleo’s expertise is underpinned by the CXCL10 novel and patented biomarker, which was first recognized as a small inflammatory molecule in ovarian most cancers tissue sections. Subsequent analysis demonstrated that CXCL10 was overexpressed in ovarian cancers, however importantly not expressed in benign illness, and stays all through the lifetime of the most cancers. The biomarker successfully gives a strong indicator in any respect phases of most cancers. Recognizing that early detection is a considerably unmet want within the medical diagnostics market, Cleo Diagnostics is concentrated on bringing to market a easy blood check to precisely detect ovarian most cancers early.
Cleo’s first clinical validation study for its ovarian most cancers triage check has been printed within the peer-reviewed worldwide journal Cancers. The article concluded that Cleo’s ovarian most cancers check was extremely correct with 95 p.c sensitivity and 95 p.c specificity, appropriately discriminated malignant from benign samples, and has outperformed and was superior to present medical strategies. The second peer-reviewed dataset has additionally been printed within the medical journal Diagnostics, which concluded that CLEO’s check has appropriately recognized most most cancers circumstances that had been missed by the usual marker CA125. It additionally eradicated the vast majority of “false optimistic” outcomes attributable to CA125 use, and it appropriately recognized the vast majority of sufferers with early-stage ovarian cancers.
CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to help the graduation of its US market entry program. HcFocus will present specialised and strategic experience to help CLEO in navigating the complexities of the US well being system and regulatory surroundings.
The addressable marketplace for a expertise like that is compelling, and with a administration group that brings to the desk a long time of management expertise within the medical expertise house, Cleo is well-positioned to leverage this market alternative.
Cleo chief govt and govt director Dr. Richard Allman has over 30 years of expertise in commercially centered scientific analysis and innovation. All through his profession, Allman has overseen and expedited a product growth pipeline protecting at least six main cancers, heart problems, type-2 diabetes and a commercially out there COVID-19 check.
Chief scientific officer Dr. Andrew Stephens boasts an equally spectacular resume. A profession analysis scientist with 20 years of expertise in molecular and mobile biology, Stephens is called in over 60 educational publications and holds quite a few patents within the most cancers remedy and diagnostic house. Cleo’s blood check seems to be for a novel and patented biomarker within the blood referred to as CXCL10, which was found by Stephens, the product of over ten years of scientific work at Monash Medical Centre’s Hudson Institute of Medical Analysis.
There’s additionally Professor Tom Jobling, Cleo’s non-executive director and lead medical advisor. As the top of gynaecological oncology at Monash Well being and visiting medical officer on the Peter MacCallum Most cancers Centre, Jobling has been treating ovarian most cancers for over thirty years. He was additionally the founding chairman of the Ovarian Most cancers Analysis Basis (OCRF)
Non-executive director Lucinda Nolan, in the meantime, brings important enterprise and strategic experience to the desk. Most just lately, she served because the CEO of the Ovarian Most cancers Analysis Basis.
These skilled professionals, along with the opposite members of Cleo’s administration and board, have developed a staged execution technique centered on de-risking the pathway to the worldwide screening market — guaranteeing that, though Cleo continues to be in its superior R&D stage, its prospects for commercialisation stay extremely promising.
Firm Highlights
- Backed by medical professionals and most cancers specialists with a long time of expertise, Cleo Diagnostics has developed a disruptive, correct and early-stage ovarian most cancers detection blood check.
- Cleo targets the CXCL10 novel biomarker, which is now identified 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 Medical Analysis, the place chief scientist Dr. Andrew Stephens acquired greater than $5 million OCRF & NHMRC funding for growth and medical research.
- The check can be supported by Professor Tom Jobling, founding father of the Ovarian Most cancers Basis and Lucinda Nolan, the inspiration’s former CEO.
- Cleo has developed a staged execution technique centered on an achievable path to market. This ensures the mission, which is at the moment in its superior R&D stage, can maximise business worth for all stakeholders.
Key Tasks
Cleo Diagnostics
Developed over a decade by Dr. Andrew Stephens, Cleo’s blood check is underpinned by the CXCL10 novel and patented protein biomarker identified to be current in all phases of ovarian most cancers. By combining CXCL10 with a number of different biomarkers in a customized algorithm, Cleo can’t solely be utilized in triage, but in addition for screening and recurrence testing. The mission is at the moment within the superior R&D stage and has to this point performed two medical research, analysing greater than 700 affected person samples within the course of.
Highlights:
- Readily Accessible: Cleo requires no further or specialised tools and could be performed in any commonplace pathology lab both by itself or as a part of a normal panel of exams ordered by a doctor.
- AI-based Danger Evaluation: As soon as the pattern has been collected and examined, Cleo leverages a proprietary algorithm to carry out a threat analysis on the affected person, figuring out the chance of a most cancers prognosis.
- Intuitive Outcomes: Cleo generates an easy-to-understand post-assessment report which might then be despatched to the affected person’s major care supplier or surgeon for triage.
- Excessive Efficiency: The Cleo prototype outperforms FDA-cleared predicates and medical guideline exams by way of accuracy and specificity.
- Present Roadmap: Cleo plans for the check to be prepared for medical use in a surgical triage setting by 2025, the place it will likely be out there initially to 1 million sufferers. Goal launch dates for recurrence, high-risk screening and mass screening are nonetheless to be decided. Moreover, the corporate has quite a few inflection factors deliberate over the following two years:
- Equipment Improvement:
- Inner trial antibody optimisation
- Finalisation of antibody choice for the Cleo test-kit
- Full re-agent growth
- Pre-IDE strategic growth
- Manufacturing:
- Institution and accreditation of ISO13485 high quality system
- Manufacturing institution of Cleo key biomarker
- Manufacturing institution of Cleo Ovarian Most cancers Equipment
- Scientific Research:
- Signal key opinion leaders and trial websites
- Carry out and finalise verification of the Cleo equipment by medical research
- Regulatory Approval:
- FDA Pre-IDE submission
- CE regulatory submissions and approval
- TGA regulatory submission and approval
- FDA submission and approval
- Equipment Improvement:
Optimistic Peer Opinions: Cleo’s first medical validation examine for its ovarian most cancers triage concluded that the ovarian most cancers check was extremely correct with 95 p.c sensitivity and 95 p.c specificity. It has appropriately discriminated malignant from benign samples, and out-performed and was superior to present medical strategies. The second peer-reviewed dataset concluded that CLEO’s check has appropriately recognized most most cancers circumstances that had been missed by the usual marker CA125. It additionally eradicated the vast majority of “false optimistic” outcomes attributable to CA125 use, and it appropriately recognized the vast majority of sufferers with early-stage ovarian cancers.
Cleo is bringing to market three examsfor ovarian most cancers prognosis, monitoring and screening.
Administration Group
Dr. Richard Allman — Chief Government Officer and Government Director
Dr. Richard Allman has over 30 years of scientific analysis management and innovation with a transparent concentrate on commercialisation. He has large expertise in analysis management, innovation administration, and mental property technique, protecting oncology, diagnostics, and product growth.
Beforehand, Allman was chief scientific officer at Genetic Applied sciences (ASX:GTG). Current successes embrace the strategic design and administration of a second-generation breast most cancers threat evaluation check from idea to business launch and an identical check for colorectal most cancers. These exams have now been NATA-accredited and comprise the primary commercially out there polygenic threat exams in Australia.
Extra just lately, Allman supervised the underlying R&D, translation, regulatory approval, patent submitting and business launch of a COVID-19 illness severity check inside 12 months. This technique has been utilised to expedite a product growth pipeline protecting six main cancers, heart problems and type-2 diabetes which had been commercially launched in March 2022.
Dr. Andrew Stephens — Chief Scientific Officer and Government Director
Dr. Andrew Stephens is a profession analysis scientist with 20 years of expertise in molecular and mobile biology analysis. He has broad expertise in educational and pre-clinical analysis and a robust concentrate on translation and the commercialisation of analysis findings. He established and leads an impartial educational analysis group on the Hudson Institute of Medical Analysis, investigating mechanisms that contribute to the formation, development and dissemination of high-grade, serous epithelial ovarian cancers. Since 2010, his analysis has centered on biomarker identification and growth in ovarian most cancers and the event of therapeutic methods to enhance affected person outcomes. He’s additionally actively concerned throughout the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has greater than 60 educational publications and quite a few patents (pending and provisional) within the most cancers therapeutic and diagnostic house.
Professor Tom Jobling — Lead Medical Advisor and Non-executive Director
Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical 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 subsequently been elected as a member of the Society of Pelvic Surgeons and can be founding father of the Ovarian Most cancers Analysis Basis (1999). He was the chairman of the Ovarian Most cancers Analysis Basis Board. His main pursuits are in radical surgical procedure for ovarian most cancers and the appliance of robotic surgical procedure 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 quite a few worldwide medical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the Worldwide Society of Gynaecological Most cancers.
Lucinda Nolan — Non-executive Director
Lucinda Nolan is a non-executive director and was most just lately the CEO of the Ovarian Most cancers Analysis Basis. She has a wealth of information and expertise throughout the general public sector and not-for-profit environments. Earlier than becoming a member of the Ovarian Most cancers Analysis Basis, she was chosen as the primary feminine CEO of the Nation Fireplace Authority, one of many world’s largest volunteer-based emergency providers organisations. She additionally spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan can be the chair of BankVic and a director on the boards 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 Superior Administration Programme at Harvard College.
Adrien Wing — Non-executive Chair
Adrien Wing started his skilled profession practising within the audit and company advisory divisions of a chartered accounting agency. He has over 25 years of expertise within the company sector with a big portion of this expertise in ASX small caps, lead in IPO transactions and put up itemizing reverse takeovers and acquisitions throughout a spread of trade sectors and jurisdictions. He additionally has a robust pedigree within the life sciences trade being the founding father of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing at the moment serves as an officer/director on the next firm boards: New Age Exploration (ASX: NAE), director and joint firm secretary; Pink Sky Power (ASX:ROG), director and joint firm secretary; Sparc Applied sciences (ASX:SPN), firm secretary; and Osmond Assets (ASX:OSM), firm secretary.
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