Oncimmune Regulatory News (ONC)

20 September 2016

Oncimmune Holdings plc

("Oncimmune" or the "Company")

New Data Highlights Effectiveness of EarlyCDT®-Lung in Assessing Lung Cancer Risk of Nodules Detected During CT Screening

Publication in Journal of Thoracic Oncology

Oncimmune Holdings plc (AIM: ONC.L), a leading early cancer detection company developing and commercialising its proprietary EarlyCDT® platform technology, announces today the publication of new data in the Journal of Thoracic Oncology1 on the effectiveness of the EarlyCDT®-Lung autoantibody test in distinguishing between malignant and benign lung nodules.

The use of computed tomography scans (CT) to screen patients at risk for lung cancer is increasing and over 1.5 million individuals have lung nodules identified annually in the United States. As CT detects large numbers of benign nodules (96% false positive rate)2, a test which can help assess a nodule's risk and thus assist physicians in identifying malignancy has great potential benefit.

The study showed that a positive EarlyCDT®-Lung test indicates that a nodule is between 2 to 3 times more likely to be a cancer. This is especially important for nodules that are too small for other methods of investigation to be effective, such as PET, or biopsy which is too invasive and expensive given the large number of nodules identified. For nodules below 15mm in diameter, this test should be of significant value as it will help identify a much smaller group of higher risk nodules where faster intervention may be warranted.

Geoffrey Hamilton-Fairley, CEO of Oncimmune commented: "The ability to distinguish between malignant and benign lung nodules is a key challenge for physicians. This study, led by Pierre Massion, MD at Vanderbilt, adds further evidence that EarlyCDT®-Lung can play a positive role in helping clinicians interpret pulmonary nodules and, significantly, do so when nodules are still small, leading to earlier detection. 

"Our intention is for Oncimmune representatives to make this study available to US pulmonologists so that an increasing number of them use the test to evaluate the risk of indeterminate nodules." 

Dr James Jett, Chief Medical Officer of Oncimmune said: "The physician's goal in evaluating pulmonary nodules is to determine which are likely to be cancer so that they can be removed early while they are in a curative stage. Likewise, physicians want to avoid sending patients to surgery to remove benign nodules (scar tissue). This study demonstrates that a positive Early CDT-Lung blood test will be of major assistance to doctors in separating lung nodules that are cancer from those that are just scar tissue."

1 Massion, P. P., MD et al, Autoantibody Signature Enhances the Positive Predictive Power of Computed Tomography and Nodule-based Risk Models for Detection of Lung Cancer, Journal of Thoracic Oncology (2016) http://authors.elsevier.com/sd/article/S1556086416309285

2 National Lung Screening Trial https://www.cancer.gov/types/lung/research/nlst

For further information:

Oncimmune Holdings plc

Geoffrey Hamilton-Fairley, Chief Executive Officer

contact@oncimmune.co.uk

Zeus Capital Limited (Nominated Adviser and Broker)

Phil Walker, Giles Balleny, Dominic Wilson

+44 (0) 203 829 5000

Media enquiries:

Consilium Strategic Communications

Chris Gardner, Matthew Neal, Lindsey Neville

oncimmune@consilium-comms.com

+44 (0) 20 3709 5708

About Oncimmune

Oncimmune is a leading early cancer detection company developing and commercialising its proprietary EarlyCDT® platform technology. Oncimmune has pioneered the development of autoantibody tests that can detect cancer up to four years earlier than other methods and can be applied to a very wide range of solid tumour types. The Company's first product, EarlyCDT®-Lung, was launched in 2012, as a CLIA test in the USA and since then over 145,000 commercial tests have been sold. EarlyCDT®-Lung is available through physicians in the US and also privately in the UK and other regions. EarlyCDT®-Lung is being used in the largest ever randomised trial for the early detection of lung cancer using biomarkers, the National Health Service (NHS) Scotland ECLS study of 12,000 high-risk smokers. EarlyCDT® tests for liver and ovarian cancer are in development.

Oncimmune, headquartered in Nottingham, United Kingdom with testing facilities in the US, joined AIM in May 2016 under the ticker ONC.L. For more information visit www.oncimmune.com