Three-year follow-up data for the ECLS trial

23 August 2021

Oncimmune Holdings plc

("Oncimmune" or the "Company")

Three-year follow-up data for the Early detection of Cancer of the Lung Scotland ("ECLS") trial

Data supports trend towards a mortality benefit of the EarlyCDT Lung blood test

Data also confirms number of late-stage cancers and deaths to be lower in patients tested

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, is pleased to announce the pre-publication of the three-year follow-up data for the Early detection of Cancer of the Lung Scotland ("ECLS") trial in medRxiv titled 'Targeted screening for lung cancer with autoantibodies'1. The pre-publication shows that after three years, the number of late-stage cancers and deaths were lower in patients tested with the EarlyCDT Lung blood test. Crucially, all cause mortality as well as cancer specific and lung cancer mortality was reduced.

The ECLS trial, believed to be the largest randomised controlled trial for the detection of cancer using blood-based biomarkers, was published in a peer-reviewed paper entitled 'Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging'2 in the European Respiratory Journal. Published last year, the study showed a 36% reduction in late-stage diagnoses of lung cancer. In addition, the results from the trial indicated a lower rate of 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 suggesting that the EarlyCDT Lung blood test followed by computerised tomograpgy (CT) imaging could produce a mortality benefit.

The three-year follow-up data now available as a pre-publication manuscript on medRxiv (https://medrxiv.org/cgi/content/short/2021.08.17.21262105v1) supports a continued trend towards a reduction in mortality. The follow-up data in this paper also showed that autoantibodies detected by the EarlyCDT Lung blood test are specific and most sensitive for early-stage disease in the first year after testing, with lung cancers detected by the EarlyCDT Lung test detected mainly at an early stage.

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 treatment2. Earlier diagnosis means that more patients should benefit from newer, more effective, chemotherapy, surgery, and radiotherapy, therefore, reducing the impact of this disease.

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

Dr Adam M Hill, CEO of Oncimmune said: "The key to cancer survival is early detection. With thousands fewer patients being referred for lung cancer tests since the start of the Covid-19 pandemic, the early detection of lung cancer has never been more important. This paper demonstrates the impact a simple blood test in combination with volumetric imaging can have on cancer mortality. Cancer specific mortality was significantly lower in those tested with EarlyCDT Lung. Assuming the three year survival from lung cancer is 80% in those tested, this would suggest 472 people need to to be tested in order to save one life, which is comparable with other established, and widely available screening programmes for other cancers.

"It is encouraging to see this data generated for the EarlyCDT Lung blood test which provides further evidence in support of its adoption. Oncimmune is in ongoing discussions to this end with healthcare providers across the UK and further afield."

1 https://medrxiv.org/cgi/content/short/2021.08.17.21262105v1

2 https://erj.ersjournals.com/content/early/2020/07/09/13993003.00670-2020

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About Oncimmune

Oncimmune is a leading immunodiagnostics developer, primarily focused on the growing fields of immuno-oncology, autoimmune disease, and infectious diseases. Oncimmune has a diversified and growing revenue from its portfolio of diagnostic products to detect early-stage cancer and a contract discovery and development service-based platform, delivering actionable insights into therapies to its pharmaceutical and biotech partners.

Our understanding of the 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 to give people extra time.

Oncimmune's ImmunoINSIGHTS platform enables life science organisations to optimise drug development and delivery, leading to more effective targeted as well as safer treatments for patients. Oncimmune's immunodiagnostic technology, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis. Our lead diagnostic test, EarlyCDT Lung, targets a vast market estimated to grow to £3.8bn by 2024. With over 200,000 tests already performed for patients worldwide and its use being supported by peer reviewed data in over 12,000 patients, we are poised to become an integral component of future lung cancer detection programmes, globally.

Oncimmune, headquartered at its laboratory facility in Nottingham, UK, and has a discovery research centre in Dortmund, Germany.

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 Study

The ECLS trial, a study of 12,209 participants, conducted in Scotland is believed to be the largest randomised controlled trial for the detection of cancer using blood-based biomarkers. 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. To determine whether the EarlyCDT Lung blood test reduced the incidence of patients with stage III/IV lung cancer, the ECLS trial compared the use of the EarlyCDT Lung blood test followed by low dose computerised tomography ("CT") scanning to 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 results of the trial, published in 2020, in the peer-reviewed European Respiratory Journal demonstrated a 36% reduction in late-stage diagnoses of lung cancer. Additionally, the ECLS trial results indicated a lower rate of 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 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 could benefit from newer, more effective, chemotherapy, surgery and radiotherapy, and so reduce the impact of this disease.

For more information, visit www.oncimmune.com