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Cleo Diagnostics
Overview
A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer-reviewed international journal Cancers. The article concluded that Cleo’s ovarian cancer test was highly accurate with 95 percent sensitivity and 95 percent specificity, correctly discriminated malignant from benign samples, and has outperformed and was superior to current clinical methods. The second peer-reviewed dataset has also been published in the medical journal Diagnostics, which concluded that CLEO’s test has correctly identified most cancer cases that were missed by the standard marker CA125. It also eliminated the majority of “false positive” results caused by CA125 use, and it correctly identified the majority of patients with early-stage ovarian cancers.
CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to support the commencement of its US market access program. HcFocus will provide specialised and strategic expertise to assist CLEO in navigating the complexities of the US health system and regulatory environment.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Throughout his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and lead medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
Company Highlights
- Backed by medical professionals and cancer specialists with decades of experience, Cleo Diagnostics has developed a disruptive, accurate and early-stage ovarian cancer detection blood test.
- Cleo targets the CXCL10 novel biomarker, which is now known to be overexpressed in all stages of ovarian cancer.
- Cleo is the result of more than a decade of research at the Hudson Institute of Medical Research, where chief scientist Dr. Andrew Stephens received more than $5 million OCRF & NHMRC funding for development and clinical studies.
- The test is also supported by Professor Tom Jobling, founder of the Ovarian Cancer Foundation and Lucinda Nolan, the foundation's former CEO.
- Cleo has developed a staged execution strategy focused on an achievable path to market. This ensures the project, which is currently in its advanced R&D stage, can maximise commercial value for all stakeholders.
Key Projects
Cleo Diagnostics
Developed over a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
Highlights:
- Readily Accessible: Cleo requires no additional or specialised equipment and can be conducted in any standard pathology lab either on its own or as part of a standard panel of tests ordered by a physician.
- AI-based Risk Assessment: Once the sample has been collected and tested, Cleo leverages a proprietary algorithm to perform a risk evaluation on the patient, determining the likelihood of a cancer diagnosis.
- Intuitive Results: Cleo generates an easy-to-understand post-assessment report which can then be sent to the patient's primary care provider or surgeon for triage.
- High Performance: The Cleo prototype outperforms FDA-cleared predicates and clinical guideline tests in terms of accuracy and specificity.
- Current Roadmap: Cleo plans for the test to be ready for clinical use in a surgical triage setting by 2025, where it will be available initially to one million patients. Target launch dates for recurrence, high-risk screening and mass screening are still to be determined. Additionally, the company has numerous inflection points planned over the next two years:
- Kit Development:
- Internal trial antibody optimisation
- Finalisation of antibody selection for the Cleo test-kit
- Complete re-agent development
- Pre-IDE strategic development
- Manufacturing:
- Establishment and accreditation of ISO13485 quality system
- Manufacturing establishment of Cleo key biomarker
- Manufacturing establishment of Cleo Ovarian Cancer Kit
- Clinical Studies:
- Sign key opinion leaders and trial sites
- Perform and finalise verification of the Cleo kit through clinical studies
- Regulatory Approval:
- FDA Pre-IDE submission
- CE regulatory submissions and approval
- TGA regulatory submission and approval
- FDA submission and approval
- Kit Development:
Cleo is bringing to market three testsfor ovarian cancer diagnosis, monitoring and screening.
Management Team
Dr. Richard Allman — Chief Executive Officer and Executive Director
Dr. Richard Allman has over 30 years of scientific research leadership and innovation with a clear focus on commercialisation. He has wide experience in research leadership, innovation management, and intellectual property strategy, covering oncology, diagnostics, and product development.
Previously, Allman was chief scientific officer at Genetic Technologies (ASX:GTG). Recent successes include the strategic design and management of a second-generation breast cancer risk assessment test from concept to commercial launch and a similar test for colorectal cancer. These tests have now been NATA-accredited and comprise the first commercially available polygenic risk tests in Australia.
More recently, Allman supervised the underlying R&D, translation, regulatory approval, patent filing and commercial launch of a COVID-19 disease severity test within 12 months. This strategy has been utilised to expedite a product development pipeline covering six major cancers, cardiovascular disease and type-2 diabetes which were commercially launched in March 2022.
Dr. Andrew Stephens — Chief Scientific Officer and Executive Director
Dr. Andrew Stephens is a career research scientist with 20 years of experience in molecular and cellular biology research. He has broad experience in academic and pre-clinical research and a strong focus on translation and the commercialisation of research findings. He established and leads an independent academic research group at the Hudson Institute of Medical Research, investigating mechanisms that contribute to the formation, progression and dissemination of high-grade, serous epithelial ovarian cancers. Since 2010, his research has focused on biomarker identification and development in ovarian cancer and the development of therapeutic strategies to improve patient outcomes. He is also actively involved across the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has more than 60 academic publications and numerous patents (pending and provisional) in the cancer therapeutic and diagnostic space.
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 University in 1980 and did his postgraduate sub-specialist training in gynaecologic oncology in London at the Royal Marsden and St Bartholomew's hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and is also founder of the Ovarian Cancer Research Foundation (1999). He was the chairman of the Ovarian Cancer Research Foundation Board. His major interests are in radical surgery for ovarian cancer and the application of robotic surgery for gynaecological malignancy.
Jobling is an active member of a research team in biomarker detection and proteomics in ovarian cancer. He is involved as a collaborative investigator on a number of international clinical 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 International Society of Gynaecological Cancer.
Lucinda Nolan — Non-executive Director
Lucinda Nolan is a non-executive director and was most recently the CEO of the Ovarian Cancer Research Foundation. She has a wealth of knowledge and experience across the public sector and not-for-profit environments. Before joining the Ovarian Cancer Research Foundation, she was selected as the first female CEO of the Country Fire Authority, one of the world’s largest volunteer-based emergency services organisations. She also spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan is also the chair of BankVic and a director on the boards of Alkira Box Hill and the Melbourne Archdiocese of Catholic Schools. She has a Master of Arts and a Bachelor of Arts (Honours) from Melbourne University and is an alum of the Advanced Management Programme at Harvard University.
Adrien Wing — Non-executive Chair
Adrien Wing began his professional career practising in the audit and corporate advisory divisions of a chartered accounting firm. He has over 25 years of experience in the corporate sector with a large portion of this experience in ASX small caps, lead in IPO transactions and post listing reverse takeovers and acquisitions across a range of industry sectors and jurisdictions. He also has a strong pedigree in the life sciences industry being the founder of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing currently serves as an officer/director on the following company boards: New Age Exploration (ASX: NAE), director and joint company secretary; Red Sky Energy (ASX:ROG), director and joint company secretary; Sparc Technologies (ASX:SPN), company secretary; and Osmond Resources (ASX:OSM), company secretary.
Positive results from Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) Study
Highlights:
- Analysis of 400 patients in Phase 2 SAMDE study for current Major Depressive Episode (cMDE) study utilising MEB-001
- MEB-001 is TrivarX’s proprietary AI-driven algorithm which can assist with the effective screening of a cMDE
- MEB-001 performance results from Phase 2 SAMDE study reported high performance, marking a significant achievement in the Company:
- Sensitivity: 87% (95% CI 73-95%)
- Specificity: 72% (95% CI 66-77%)
- Positive Predictive Value: 35% (95% CI 27-45%)
- Negative Predictive Value: 97% (95% CI 93-99%)
- Results provide strong validation of MEB-001’s ability to assist in the screening and diagnosis of a cMDE – a condition which is commonly misdiagnosed
- There is currently no screening undertaken for cMDE in sleep centres in the US or globally, representing a major commercial opportunity for TrivarX
- Results advance TRI’s aim to become the first depression screening tool used in clinical practice in sleep centres
There is a well-established connection between mental health conditions, such as depression, and sleep disturbances. People with insomnia may have a tenfold higher risk of developing cMDE and among people with depression, 75% of sufferers have trouble falling or staying asleepi. Furthermore, misdiagnosis of major depressive disorder is estimated at upwards of 65% in the USii. Despite this, depression screening is not routinely included in sleep studies, even though up to 21% of people undergoing a sleep study have depressioniii.
Positive results from SAMDE study highlight MEB-001’s significant potential:
The objective of the study (ClinicalTrials.gov ID NCT05708222) was to use MEB-001 to detect the likelihood of a cMDE using Clinician Reporting Outcomes (CRO) assessment in individuals referred to a sleep clinic. A total of 400 patients were recruited across 15 sleep centres in the US. Out of these, 73 patients were excluded due to incomplete data or a split night/titration sleep study. MEB-001 also automatically identified 32 patients with significant anomalies in their sleep data. Notably, the MEB-001 algorithm was locked prior to the analysis ensuring no data from Phase 2 was used in its training.
Analysis of the results showed that MEB-001 reported promising performance across key parameters including sensitivity of 87% (95% CI 73-96%), specificity of 72% (95% CI 66-77%), positive predictive value (PPV) of 35% (95% CI 27-45%) and negative predictive value (NPV) of 97% (95% CI 93-99%) (refer table below).
These results provide considerable validation of MEB-001 and its ability in the screening and diagnosis of a current Major Depressive Episode (cMDE) in test subjects.
Management commentary:
Non-executive Chairman, David Trimboli said: “We are very excited to share the results from our Phase2 study, which highlight the effectiveness of MEB-001 in screening for cMDE. This is underscored by the significant increase in sensitivity coming from recent improvements to the underlying algorithm, which was increased from 71% in Phase 1, to 87% in Phase 2 – demonstrating that the algorithm can successfully identify more people with cMDE. Our very high NPV validates MEB-001’s potential as a screening test, with the likelihood of having depression when testing negative to be less than 3%.
“There is currently no screening undertaken for cMDE in sleep centres in the US or globally. Our most recent results reaffirm the potential of MEB-001 to become the first depression screening tool used in clinical practice in sleep centres and marks a significant achievement in the Company’s history.”
Click here for the full ASX Release
This article includes content from TrivarX, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Positive Phase 2a Fibromyalgia Results Deliver Pain Reduction in 100% of Patients, Strengthening IP Position and Clinical Trial Strategy
- Phase 2a fibromyalgia trial undertaken with University of Michigan (“UOM’) with results presented at the IASP 2024 World Congress on Pain 9 August 2024 in the Netherlands
- All patients dosed with TRP-8802 (TYP’s oral psilocybin formulation), and administered psychotherapy reported an improvement in fibromyalgia pain severity, sleep, pain interference and at least 3 other endpoints measured one month after dosing
- Fibromyalgia is a condition associated with widespread pain – 1m people in Australiai and ~10m people in the USii suffer from it and there are currently limited treatment options
- Results highlighted that there was a clinically meaningful reduction in pain, pain interference and fatigue
- Patients also reported a number of other improvements including clinically meaningful improvements in quality-of-life measures such as sleep, physical activity, and the ability to participate in daily social activities
- Clinically meaningful reduction in anxiety and improved cognitive abilities were also reported in 4 out of 5 patients dosed
- In addition, one patient reported during follow-up that their sense of smell had returned following a COVID- 19 diagnosis in 2021
- Results highlight the significant potential for psychedelic-assisted therapy as a compelling treatment pathway for fibromyalgia when compared to the inadequacies of incumbent treatments
- Results considerably strengthen Tryp’s IP position and lay a strong foundation for a future trial using TRP- 8803 (IV-infused psilocin) – Phase 2 trial planning now underway and expected to commence H1 2025
- Additional clinical trials progressing well at MGH for patients with IBS, and the beginning of Cohort 3 in the TRP-8803 Healthy Volunteer Study expected to begin soon – updates to be provided in due course
The trial was designed to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with fibromyalgia, a condition associated with widespread pain and comorbidities that significantly impact daily living and patient well-being. The trial was undertaken by the UOM, a top-ranked public university in the US in collaboration with Tryp.
Results highlighted that 100% of patients experienced reductions in fibromyalgia pain, sleep disturbance and pain interference (refer figures one and two below).
Whilst appreciating the limitations of the small number of patients and the open label nature of the ‘signal’ style study, the results are highly encouraging and considerably strengthen TYP’s intellectual property position. Further, the results validate Tryp’s clinical trial approach targeting nociplastic pain with an initial focus on fibromyalgia and will inform an additional clinical study utilising TRP-8803 (IV-infused psilocin), which is expected to commence H1 2025.
Figure one: Individual patient (001-005) and pooled results highlighting improvements in fibromyalgia domains as presented by University of Michigan 9 August 2024 (adapted)
Figure two: Individual patient and pooled results as presented by University of Michigan 9 August 2024 (adapted)
Trial background:
The study was an open-label clinical trial with psychotherapy, seeking to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with fibromyalgia. A total of five patients were recruited and were administered two doses of TRP-8802 in 15mg initial dose and 25mg second dose formats, two weeks apart. Patients were administered psychotherapy in concert with TRP-8802 and results were compared to baseline values one month following the completion of the second dose.
Click here for the full ASX Release
This article includes content from Tryptamine Therapeutics Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Cleo Diagnostics Investor Kit
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