ERJ publishes results from the ECLS study

RNS Number : 6794U

Oncimmune Holdings PLC

31 July 2020

 

31 July 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

European Respiratory Journal publishes results from the

Early detection of Cancer of the Lung Scotland ("ECLS") study

Publication in peer reviewed journal validates clinical utility of EarlyCDT Lung, furthering the impact of the ECLS data in commercial discussions with substantial health systems

The study is believed to be the largest randomised controlled trial for the detection of lung cancer using blood-based biomarkers and demonstrates a 36% reduction in later stage diagnoses of lung cancer

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, announces that The European Respiratory Journal - a leading lung disease focused scientific publication and flagship journal of the European Respiratory Society - has published the peer reviewed results from the Early detection of Cancer of the Lung Scotland ("ECLS") trial, delivered by the Universities of Dundee and St Andrews with NHS Tayside, and co-funded by Oncimmune, the Scottish Chief Scientist Office and the Scottish Government.

The paper titled 'Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging' which is now available online¹ and will be replicated in print before Q3 2020, evaluates the effectiveness of Oncimmune's EarlyCDT Lung test in reducing the incidence of patients presenting with late-stage lung cancer at diagnosis.

To determine whether the EarlyCDT Lung blood test reduced the incidence of patients with stage III/IV lung cancer, the ECLS trial in 12,208 patients compared the use of the EarlyCDT Lung blood test followed by low dose computerised tomography ("CT") scanning to standard clinical practice. In Scotland, lung cancer affects more than 5,000 people every year of which approximately 4,000 will die of the disease, usually because the diagnosis is made too late for curative treatment.

The ECLS trial is believed to be the largest randomised controlled trial for the detection of cancer using blood-based biomarkers conducted anywhere in the world to date and demonstrated a 36% reduction in late stage diagnoses of lung cancer. In addition, the ECLS trial results indicated a lower rate of both all deaths and lung cancer-related deaths among people in the intervention arm of the trial after two years compared with people in the control group. This suggests that the EarlyCDT Lung test followed by CT imaging could produce a mortality benefit: the 3 year follow up data - scheduled to be analysed imminently - will be critical in substantiating this.

The paper concludes that blood-based biomarker panels, such as the EarlyCDT Lung test, followed by low dose CT, can detect stage I/II lung cancers earlier than standard clinical practice. Earlier diagnosis means that more patients should benefit from newer, more effective, chemotherapy, surgery and radiotherapy, and so reduce the impact of this disease.

Further follow-up analyses on this unique, globally significant cohort will be performed after 5 and 10 years.

Dr Adam M Hill, CEO of Oncimmune, said:   "We are delighted to see the ECLS trial data published in the European Respiratory Journal, as it both expands the availability of these results in the wider pulmonology community and confirms through peer review the findings and clinical potential of EarlyCDT Lung. The ECLS trial data was presented on the Presidents podium at WCLC 2019 in Barcelona last year. This publication will unlock discussions with a number of health systems on implementation, many of whom have been looking forward to the validation that this much anticipated peer review brings. We and our partners will now work at speed with health authorities in the UK and further afield to roll out EarlyCDT Lung more widely, ahead of a fuller analysis of the survival benefit of EarlyCDT Lung."

Professor Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews, the Chief Investigator for the ECLS trial, said: "I hope that the results of this trial will have globally significant implications for the early detection of lung cancer by showing how a simple blood test, followed by CT scans, is able to increase the number of patients diagnosed at an earlier stage of the disease, when surgery is still possible and prospects for survival much higher."

^{1 https://erj.ersjournals.com/content/early/recent}

For further information:

Oncimmune Holdings plc

Adam Hill, Chief Executive Officer

Matthew Hall, Chief Financial Officer

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Zeus Capital Limited (Nominated Adviser and Joint Broker)

Andrew Jones, Daniel Harris, Victoria Ayton

[phone]

finnCap (Joint Broker)

Geoff Nash, Matthew Radley, Tim Redfern

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About Oncimmune

Our intimate understanding of the human immune system enables us to harness its sophisticated response to disease to detect cancer earlier and to support the development of better therapies.

The key to improving cancer survival is early detection and better selection for therapy. As a company, we are driven by our passion to improve cancer survival and give people extra time. Oncimmune's immunodiagnostic test, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis.

The unique combination of our core technology and understanding of the immune system, powers our ImmunoINSIGHTS service; a proprietary platform that enables life science organisations to optimise drug development and delivery, leading to more effective, targeted as well as safer treatments for patients.

Oncimmune was founded in 2002 and launched its platform diagnostic technology in 2009, followed by the launch of its first commercial tests, EarlyCDT Lung and EarlyCDT Liver. To date, over 200,000 tests have been performed for patients worldwide. EarlyCDT Lung was also used in what is believed to be the largest randomised controlled trial for the early detection of lung cancer using biomarkers, the successful National Health Service (NHS) Early detection of Cancer of the Lung ("ECLS") trial of 12,208 high-risk smokers in Scotland. This trial demonstrated that EarlyCDT Lung reduced the incidence of patients with late-stage lung cancer or unclassified presentation at diagnosis, compared to standard clinical practice.

Oncimmune, headquartered at its laboratory facility in Nottingham, UK, has a discovery research centre in Dortmund, Germany and a partner representative office in Shanghai, China. Oncimmune joined the Alternative Investment Market (AIM) of the London Stock Exchange in May 2016 under the ticker ONC.L.

What is EarlyCDT Lung?

EarlyCDT is a simple blood test that detects the elevated presence of autoantibodies generated by the body's immune system as a natural defence against cancer cells.

EarlyCDT Lung is the world's most thoroughly validated blood test for the detection of lung cancer and requires only a small volume of blood which can be taken using a test in the home or community setting as well as a doctor's surgery. Shown to detect lung cancer on average four years earlier compared to current standard clinical diagnosis, EarlyCDT Lung can also provide an effective assessment of cancer risk in indeterminate pulmonary nodules (IPNs).

Details of the ECLS trial

The trial was open to adults aged 50-75 considered to be at high risk of lung cancer because of smoking and family history, and healthy enough to undergo potentially curative therapy. The intervention was the EarlyCDT Lung test, followed by X-ray and computerised tomography (CT) scan in those with a positive test result. The comparator was standard clinical practice in the UK. The primary endpoint was the difference, at 24 months after randomisation, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis in the intervention arm and those in the control arm.

The trial was supported by the University of Dundee, NHS Tayside and co-funded by Oncimmune, the Scottish Chief Scientist Office and the Scottish Government. It was headed by Chief Investigators Professor Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews, and Dr Stuart Schembri, until recently consultant Physician in Respiratory and General Internal Medicine at NHS Tayside. It involved collaborators at the University of Glasgow, with further work from the Universities of Aberdeen, Nottingham and Toronto, NHS Scotland, the Scottish Government, The Canberra Hospital and Oncimmune, who developed the EarlyCDT Lung blood test. Tayside Clinical Trials Unit was responsible for trial delivery, data management and analysis.

The abstract was presented by Chief Investigator for the trial, Professor Sullivan in the Presidential Symposium of the World Conference for Lung Cancer 2019, the world's largest meeting dedicated to lung cancer and other thoracic malignancies, hosting more than 7,000 delegates from more than 100 countries.

In February 2020, Oncimmune launched a series of photographs for an exhibition titled 'Extra Time. Portraits of hope and survival from early cancer detection'. Behind the science of the ECLS study were human stories. 'Extra Time' highlighted the stories of the medical professionals who worked relentlessly to identify people who met the criteria for the study, invited them to take part, undertook tests as well as monitoring their progress. But most importantly, 'Extra Time' shone a light on the stories of the people themselves who took part, as well as their families, friends and support networks. These stories illustrate the unmet patient need for diagnosing  lung  cancer in its early stages and is now available to view online www.extratime.gallery.

For more information, visit  www.oncimmune.com

 

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