Oncimmune Regulatory News (ONC)

21 October 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

Abstracts of Studies using EarlyCDT® Lung blood test Presented to American College of Chest Physicians (CHEST) Annual Meeting 2020

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, is pleased to note that recently published data from two clinical studies using Oncimmune's EarlyCDT® Lung blood test, which is marketed in the US by Biodesix Inc. as Nodify CDTTM, confirmed both previously published performance, and the utility of combining Nodify CDT and Nodify XL2® tests to enhance diagnostic performance. Furthermore, these studies were recently presented at the American College of Chest Physicians (CHEST) annual meeting 2020.

The first paper ('Abstract #A1464/Poster #P1319: 'Identification of Likely Malignant Indeterminate Pulmonary Nodules by Analysis of Autoantibodies Against Lung Cancer-Associated Antigens'[1]) assessed the performance of the EarlyCDT Lung blood test in PANOPTIC clinical trial samples to further validate the clinical utility of the test in patients with incidentally identified lung nodules when correlated with clinical outcomes (average 2 years follow-up). The reported specificity 93% (95% confidence interval (CI) 86-97%) and positive predictive value (PPV) 74% (CI 57-85%) correlates with previous publications of the EarlyCDT Lung blood test.

The second paper ('Abstract #A1476/Poster #P1324: 'Use of Two Blood-Based Biomarker Tests in Series to Reclassify Risk of Indeterminate Pulmonary Nodules'[2]) evaluated the utility of combining Nodify CDT and Nodify XL2 tests in series. This combination strategy is aligned with the marketing strategy of both products by Biodesix in the US. 32% of the IPNs in the low-moderate risk category were reclassified into either the high-risk category by Nodify CDT or the very low risk category by Nodify XL2. Therefore, this testing strategy could have reclassified 3 malignant nodules into earlier biopsy, and 6 benign nodules that unfortunately underwent unnecessary invasive procedures. By shifting 32% of patients into risk groups with different guideline recommended diagnostic plans, the combined testing strategy would have reduced delays in diagnosis of malignant nodules and helped reduce unnecessary procedures on benign nodules.

Oncimmune's EarlyCDT Lung blood test is marketed in the US under Biodesix's Nodify Lung brand as Nodify CDT. The test will assist physicians to identify patients with lung nodules at high risk of lung cancer. This test partners with Biodesix's existing Nodify XL2 test which is designed to help identify lung nodules with a very low risk of cancer. Both tests will be offered together as the Nodify LungTM Nodule Risk Assessment strategy, giving physicians the ability to order both tests from a single blood draw.

Biodesix has a direct US national sales force who sell direct into pulmonologists and corporately into national hospital systems.

Dr Adam M Hill, CEO of Oncimmune commented: "Whilst the EarlyCDT Lung blood test is underpinned by substantive evidence of its utility in IPN patients and reduction in unnecessary invasive procedures, I welcome this independent validation of the panel with the important PANOPTIC sample set, and confirmation of the utility of a combined rule-in and rule-out strategy in the US nodule clinic setting."

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, Daniel Harris, Victoria Ayton

+44 (0)20 3829 5000

N+1 Singer (Joint Broker)

Aubrey Powell, Harry Gooden, Iqra Amin, James Fischer

+44 (0)20 7496 3000

WG Partners (Joint Broker)

David Wilson, Chris Lee

+44 (0)20 3705 9321

Media enquiries:

FTI Consulting

Ben Atwell, Michael Trace, Alex Davis

Oncimmune@fticonsulting.com

+44 (0)20 3727 1000

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 to 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 AIM Market 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).

For more information, visit www.oncimmune.com