Oncimmune Regulatory News (ONC)

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4 June 2019

Oncimmune Holdings plc

("Oncimmune" or the "Company")

Positive Top Line Results for Early Cancer Detection Test - Lung Cancer Scotland ("ECLS") Study

· ECLS study meets primary end-point - to assess the effectiveness of EarlyCDT®-Lung test in reducing incidence of patients with late-stage lung cancer at diagnosis, compared with standard clinical practice

· The ECLS study, conducted in Scotland with 12,210 patients, is believed to be the largest randomised controlled study using biomarkers for the detection of lung cancer

· A submission on the full ECLS study is being prepared for a leading peer-reviewed medical publication

· Preparations are underway for a phased evaluation in Scotland expected to recruit up to 200,000 patients each to be tested with EarlyCDT-Lung to be supplied by Oncimmune on negotiated commercial terms

Oncimmune Holdings plc (AIM: ONC.L), a leading global immunodiagnostics group, today announces positive top line results from the Early Cancer Detection Test - Lung Cancer Scotland ("ECLS") study. The ECLS study, believed to be the largest1 randomised controlled study for the early detection of lung cancer using biomarkers, recruited 12,210 patients each of whom were followed up for a minimum of two years.

The Company is pleased to report that the study met its primary endpoint showing that the use of EarlyCDT-Lung with subsequent X-ray and computerised tomography (CT) scan reduced the incidence of patients with late-stage lung cancer2 or unclassified presentation at diagnosis, compared to standard clinical practice.

The ECLS study, sponsored by the University of Dundee and NHS Tayside and co-funded by the Chief Scientist Office, Scottish Government and Oncimmune was headed by Principal 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. A submission of the full ECLS study findings is being prepared for a leading peer-reviewed medical publication and is expected to be published in Q3 2019.

Additionally, a late breaking abstract is being prepared for presentation to The International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer on 7-10 September 2019. The IASLC 2019 is the world's largest meeting dedicated to lung cancer and other thoracic malignancies, hosting more than 7,000 delegates from more than 100 countries3.

The Company is also pleased to report that preparations are underway in Scotland for the conduct of a phased population-based evaluation to assess the implications of diagnosis with EarlyCDT-Lung on survival and mortality in a real-world setting. The initial phase is expected to recruit up to 200,000 patients, each to be tested with EarlyCDT-Lung to be supplied by Oncimmune on negotiated commercial terms.

Dr Adam M Hill, CEO of Oncimmune commented: "The final results from the ECLS study, which I believe is the largest study of its type ever undertaken for early lung cancer detection, represents the culmination of over 16 years of research and development by Oncimmune's scientists and our collaborators. I am particularly excited about the potential now for scalable impact using EarlyCDT-Lung in a cancer control evaluation in Scotland, expected to commence later this year as well as the ripple effect of this landmark study on lung screening programmes further afield."

Details of the ECLS Study

ECLS is a randomised controlled study of 12,210 participants in areas of Scotland. Adults aged 50-75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0-2) were eligible to participate. The intervention is the EarlyCDT-Lung test, followed by X-ray and computerised tomography (CT) scan in those with a positive test result. The comparator is standard clinical practice in the UK. The primary endpoint is 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. There are also a number of secondary endpoints, details of which will be provided when the ECLS study is fully reported.

-Ends-

For further information:

Oncimmune Holdings plc

Adam Hill, Chief Executive Officer

Matthew Hall, Chief Financial Officer

contact@oncimmune.co.uk

Zeus Capital Limited (Nominated Adviser and Joint Broker)

Andrew Jones, Mike Seabrook

+44 (0)20 3829 5000

Bryan, Garnier & Co Limited (Joint Broker)

Phil Walker, Dominic Wilson

+44 (0)20 7332 2500

Media enquiries:

FTI Consulting

Brett Pollard, Michael Trace, Alexander Davis

Oncimmune@fticonsulting.com

+44 (0)20 3727 1000

About Oncimmune

Beating cancer, one test at a time

Oncimmune is a leader in the development, manufacture and commercialisation of cancer specific immunodiagnostics for the screening, detection and care of cancer. Oncimmune also develops precision medicine and patient stratification tools for leading pharmaceutical multinationals in both immuno-oncology and autoimmune disease. Oncimmune is working to change how cancer is diagnosed and treated. Its patented technology detects evidence of the body's natural response to cancer, enabling detection four years or more before standard clinical diagnosis. Oncimmune's tests facilitate clinical decision-making and are complementary to diagnostic technologies, making them valuable additions to established and new care pathways. Oncimmune partners with leading developers and distributors to make our technology available globally. 

Oncimmune was founded in 2002 and launched its platform technology in 2009, followed by its first commercial tests, EarlyCDT-Lung and EarlyCDT®-Liver. To date, over 155,000 tests have been performed for patients worldwide and EarlyCDT-Lung is being used in what is believed to be the largest randomised controlled study using biomarkers for the detection of lung cancer, the National Health Service (NHS) ECLS study of 12,210 high-risk smokers in Scotland. Oncimmune, headquartered at its laboratory facility in Nottingham, UK, has a discovery research centre in Dortmund, Germany and a CLIA lab in Kansas, US as well as an office in London, UK 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?

A blood test using a panel of seven immunogenic proteins for the testing of tumour-related antibodies specific to lung cancer.

For more information, visit www.oncimmune.com