Oncimmune Regulatory News (ONC)

28 October 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

Clinical study initiated by Biodesix to further support adoption of EarlyCDT® Lung in US market

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, is pleased to note the initiation of a study by Biodesix Inc ("Biodesix") using Oncimmune's EarlyCDT® Lung blood test, which is marketed in the US by Biodesix as Nodify CDTTM.

Biodesix have initiated the "ALTITUDE" clinical utility study designed to evaluate the performance of Nodify LungTM (Nodify XL2TM and Nodify CDT in combination) in a randomised controlled study. The study "A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules" seeks to further demonstrate the efficacy of the Nodify XL2 and Nodify CDT tests. A secondary focus of the study will be to further understand the economic impact of the tests in guiding treatment choices and the potential impact of our tests in reducing overall healthcare costs in the US.

The ALTITUDE study objectives are to evaluate how the addition of the Nodify Lung test result impacts the clinical decision making for patients with new, incidentally identified solid lung nodules assessed as low to moderate risk of lung cancer. A total of 2,000 patients are expected to be enrolled in the study.

The trial has an adaptive study design with a blinded standard of care arm and 2:1 randomisation for open-label results for Nodify XL2. The first patients will be enrolled before the end of 2020, with Phase 1 of the study including only Nodify XL2, expected to enrol 500 patients. Phase 2 of the adaptive study design will include an open-label arm for Nodify CDT, which is aligned with Biodesix's commercial testing algorithm.

Oncimmune's EarlyCDT Lung blood test is marketed in the US under Biodesix's Nodify Lung brand as Nodify CDT. The Nodify CDT test assists physicians in identifying patients with lung nodules at high risk of lung cancer and is partnered with Biodesix's existing Nodify XL2 test, which is designed to help identify lung nodules with a very low risk of cancer. Both tests are offered in combination as the Nodify Lung 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: "Oncimmune is committed to producing further evidence that supports both adoption and reimbursement decisions in the markets where EarlyCDT Lung is available. Part of our agreement with Biodesix in June 2019 was to continue to deliver high quality evidence in the US market with EarlyCDT Lung. The ALTITUDE study will build upon the data presented last week at the American College of Chest Physicians from the PANOPTIC study, whilst adding to the substantial evidence base already underpinning the use of our product globally."

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