Oncimmune Regulatory News (ONC)

17 March 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

NICE concludes review of EarlyCDT Lung® and issues its advice across NHS England

· NICE Medtech Innovation Briefing on EarlyCDT Lung, shared with NHS commissioning groups, provides overview of technology to guide potential use within the NHS

· MIB concludes EarlyCDT Lung can help early diagnosis of lung cancer in high risk patients and its intended place in therapy would be as an addition to standard care

· NICE review confirms EarlyCDT Lung enables risk stratification of patients with IPNs and also states it could be offered before CT surveillance, potentially enabling earlier treatment, improved outcomes, NHS resource savings and reduced waiting times

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, today announces that the UK's National Institute for Health and Care Excellence ("NICE") has completed a review of EarlyCDT® Lung, the Company's simple blood test for the early detection of lung cancer, concluding that the test can successfully aid early diagnosis of lung cancer in high risk patients. NICE reviewed EarlyCDT Lung for cancer risk stratification of indeterminate pulmonary nodules ("IPNs").

As a consequence of the review, NICE have prepared a Medtech Innovation Briefing ("MIB") providing advice that will be available to all NHS England clinicians, managers and procurement professionals. The briefing, intended to support NHS commissioners and staff who are considering using new medical or diagnostic technologies, states that EarlyCDT Lung enables earlier and accurate diagnosis of lung cancer in high risk patients which could mean intervention is offered early, with the potential benefit of early treatment and improved outcomes. The MIB also notes that this could have a wider benefit by saving other NHS resources (CT scanning and radiologists) and reducing waiting times.

The MIB states that evidence from the studies across Europe and North America (four studies involving around 15,000 adult patients) shows EarlyCDT Lung can detect early stage lung cancer and may improve diagnostic performance, specifically to be more effective at ruling in lung cancer than current risk models. The briefing further states that the evidence presented demonstrates that EarlyCDT Lung can enhance diagnostic yield and improve the prediction of the risk of lung cancer.

The MIB says that the EarlyCDT Lung test is intended to be used in addition to standard care to aid early detection of lung cancer in people at high risk. It can also be used in the risk stratification of people with IPNs identified by chest Computerised Tomography ("CT") or X-ray. If adopted, the test will be offered before deciding to place a patient into CT surveillance, meaning patients with results indicative of increased risk of malignancy can move into the intervention pathway without delay, resulting in earlier treatment which has been associated with more favourable patient outcomes.

A number of comments from clinical experts are included in the MIB. One specialist noted that EarlyCDT Lung has the potential to reduce cases for PET scans and speed up the pathways, whilst another stated that EarlyCDT Lung can improve IPN management as there is a move towards implementing lung cancer screening. Other specialists felt that patient exposure to CT scans will be reduced, as well as lessening anxieties should a CT deliver a false positive result.

Oncimmune will continue to work with the NHS Academic Health Science Networks to disseminate this advice and drive adoption of the EarlyCDT Lung innovation across NHS England.

Dr Adam M Hill, CEO of Oncimmune said: "On behalf of the 35,000 people in the UK who lose their lives each year to lung cancer1., we welcome the findings of this NICE review and its consequential advice to all NHS England clinicians, managers and procurement professionals. Our EarlyCDT Lung test offers the opportunity to find lung cancer at the very earliest stage with a simple, non-invasive blood test. We are ready to work with the NHS to make this test available to anyone who has a risk of developing lung cancer thereby enabling them to get treatment earlier and improve their chances of recovery and survival."

1. Deaths from lung cancer, 2015-2017, UK, Cancer Research UK 

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

finnCap (Joint Broker)

Geoff Nash, Matthew Radley, Tim Redfern

+44 (0)20 7220 0500

Bryan, Garnier & Co Limited (Joint Broker)

Phil Walker, Dominic Wilson

+44 (0)20 7332 2500

Media enquiries:

FTI Consulting

Ben Atwell, Michael Trace, Alex Davis

Oncimmune@fticonsulting.com

+44 (0)20 3727 1000

About NICE Medtech Innovation Briefings

Medtech Innovation Briefings (MIBs) are NICE advice and are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The information provided in the MIB includes a description of the technology, how it's used and its potential role in the treatment pathway. A MIB also includes a review of relevant published evidence and the likely costs of using the technology. MIBs are commissioned by NHS England and produced in support of the NHS Five Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.

About Oncimmune

Beating cancer, one test at a time 

The battle against cancer hinges on early detection and then the delivery of effective treatment. Oncimmune is working to revolutionise both the detection of cancer and its treatment by harnessing the sophisticated disease detecting capabilities of the immune system to find cancer in its early stages. Our range of diagnostic tests assist clinicians to identify the presence of cancer four years or more before standard clinical diagnosis, whilst our technology platform and sample biobanks are helping healthcare companies to develop new cancer treatments.

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 158,000 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) ECLS trial of 12,209 high-risk smokers in Scotland which demonstrated 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 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