Oncimmune Regulatory News (ONC)

6 October 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

Oncimmune and Medicines Discovery Catapult awarded UK Government funding for development of an Infectious Disease research tool for use in COVID-19

Validated research tool to be used to predict disease severity and individual

therapeutic response to COVID-19 in aid of rapid vaccine and drug development

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, today announces the award of funding from the 'UK Research and Innovation ("UKRI") Ideas to Address COVID-19' programme, to support a joint collaboration between Oncimmune and Medicines Discovery Catapult ("MDC") to deliver the IMmunity Profiling of pAtients with COVID-19 for Therapy and Triage ("IMPACTT") programme.

This collaboration represents a critical partnership in response to the COVID-19 pandemic and will focus on enabling better treatment selection for patients according to their immune profile.

The IMPACTT programme will collect samples and clinical data from 3,000 UK COVID-19 patients to be studied by Oncimmune to develop and validate an Infectious Disease NavigAID™ panel of biomarkers that can be used in COVID-19 research. This research tool will be designed to predict both likely patient response to the virus and effectiveness of vaccines and treatment against it.

Oncimmune currently has over 800 SARS-CoV-2 related antigens and peptides for profiling COVID-19 patients and predicting their response to vaccines and therapeutics against the virus. MDC, which will be responsible for collecting the patient samples, is the UK Government's hub for medicines research and development and the organisation responsible for setting up the Lighthouse Lab Network, a multi-party collaboration of laboratories processing COVID-19 test samples. This critical collaboration leverages the strengths of both organisations to rapidly develop a profiling tool to optimise novel therapeutics in patients with differing COVID-19 severity.

Responding to the UK Government's call for research into the risk factors, transmission and prevalence of COVID-19, this programme will analyse the immune system's response of COVID-19 patients, and using Oncimmune's proprietary profiling platform, Oncimmune will stratify these patients into three categories of response to the virus - mild, moderate and severe. Oncimmune will then use this data to develop, refine and validate a dedicated NavigAID panel, which can then be deployed to predict COVID-19 disease severity and therapeutic response.

As a result of this programme, the collaborators will have developed an extensive COVID-19 sample severity-based biorepository and data registry from 3,000 UK COVID-19 patients, which will be utilised to support Oncimmune's future commercial projects with its growing portfolio of biopharmaceutical customers. This biorepository and the NavigAID panel will be used to test, evaluate and optimise novel therapies to mitigate the effects of this disease, building upon Oncimmune's existing bioresource and data assets, which will also be further increased over time to address a broader range of infectious diseases.

Over 1,220 biologic therapeutics, including over 200 vaccines1 for COVID19, are currently thought to be in clinical trials globally. Anticipating the immune response to these novel therapeutics in patients with differing disease severity, as well as predicting potential side effects to these drugs, will be critical for optimising individual therapy and developing safe and effective vaccines. Oncimmune anticipates having an Infectious Disease NavigAID panel delivering results within two months of the commencement of the development phase and available to Academic Partners. Within six months, it is expected to be in a position to support commercial projects for its biopharmaceutical customers, for which a number of discussions are already underway.

Alok Sharma, Business Secretary said:

"Our scientists and researchers are at the forefront of global efforts to better understand COVID-19 and have been working tirelessly to identify new and innovative therapies that will save lives. 

"By backing this pioneering project, we are ensuring that the best therapeutic approaches can be offered to the right patients at the right time."

Dr Adam M Hill, CEO of Oncimmune said: 

"As the COVID-19 pandemic moves from the immediate challenge of developing novel diagnostics, we are now entering a phase where the world needs to better understand this disease in infected patients in order to optimise therapeutic outcomes. Oncimmune has been in discussion for some months now to utilise its differentiated technical knowledge to develop a comprehensive diagnostic tool capable of characterising the immune system's response to COVID-19 and, as a consequence, being able to better predict patient symptom severity and treatment response. Together with MDC, this programme is now underway, and will shortly be ready to optimise the first wave of novel therapeutic approaches to preventing and treating this disease.

"Once completed, this dedicated Infectious Disease NavigAID panel will be a critical resource for biopharmaceutical companies in their development of biologic medicines and vaccines against COVID-19. At the same time, Oncimmune will be developing an important biobank and knowledge resource in the UK which will enable a greater understanding of which therapy should be used when, and in whom".

Professor Chris Molloy, Chief Executive Officer at Medicines Discovery Catapult (MDC) added:

"Since co-ordinating the creation of the UK's Lighthouse Labs network and delivering one of those labs, based at Alderley Park in Cheshire, MDC has been at the forefront of the fight against COVID-19. This partnership with Oncimmune will draw on MDC's access to nationwide biobanks and supplier networks, helping to unlock invaluable COVID-19 samples for UK biotechs, while also providing expertise in navigating the complex brokering and procurement process for obtaining samples.

"We look forward to working with Oncimmune to broaden our collective intelligence on how the virus exhibits in different patients, subsequently leading to stratified and then more tailored therapeutics according to the varying need, constituting a pivotal shift in the efforts to understand and combat COVID-19."

Link to Extra Time podcast with Chis Molloy, CEO MDC on the collaboration: https://apple.co/3nljpLS

Watch Dr Adam M Hill present why Oncimmune is undertaking this work, its importance in fighting COVID-19 and what it means commercially to Oncimmune: https://bit.ly/34quaUn

1.COVID-19 dashboard, Global Data. Accessed on 19.08.2020

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

+44 (0)20 7496 3000

WG Partners (Joint Broker)

David Wilson, Chris Lee

+44 (0)203 705 9321

Media enquiries:

FTI Consulting

Ben Atwell, Michael Trace, Alex Davis

Oncimmune@fticonsulting.com

+44 (0)20 3727 1000

What is ImmunoINSIGHTS?

The ImmunoINSIGHTS service business leverages Oncimmune's technology platform and methodologies across multiple diseases, to offer life-science organisations actionable insights for therapies across the development and product lifecycle. Our core immune-profiling technology is underpinned by our library of over eight thousand immunogenic proteins, one of the largest of its kind. This helps identify trial participants and patients into clinically relevant subgroups, enabling development of targeted and more effective treatments.

What is SeroTag?

Oncimmune's proprietary biomarker discovery engine, which is leveraged in our ImmunoINSIGHTS services to discover and validate novel biomarkers can help stratify patients in multiple cancer indications and with different autoimmune diseases.

This high-throughput, multiplex technology is based on one of the largest, in-house protein libraries, as well as a unique, ever-growing repository of disease data for indications including, but not limited to, autoimmune diseases and cancer. As a result, SeroTag is helping to address and monitor a number of challenges currently hindering the successful development and broader application of both cancer immunotherapies and treatments for autoimmune diseases.

The platform is being applied to discover and validate biomarkers and develop precision diagnostic tools from minimally invasive liquid biopsies. SeroTag analyses autoantibodies-some of the most stable analytes-and is used most frequently for the identification of IgG isoforms, in addition to IgM and IgA, from just a few drops of serum.

The SeroTag platform acts as the primary discovery engine that feeds into the creation of Oncimmune's NavigAID disease-specific stratification panels-precision medicine tools which are enabling patient and disease stratification and support therapeutic development.

What is NavigAID?

Oncimmune's NavigAID arrays are thoroughly validated containing well defined antigen panels, largely encompassing markers of interest for each of the disease types being investigated.

Our portfolio of panels includes out-of-the-box NavigAID arrays for immuno-oncology and autoimmune diseases. These validated panels are frequently used as the starting point for collaborations with partners to add further markers of interest to their specific therapy and its specific indication.

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 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

For more information, visit www.oncimmune.com

About Medicines Discovery Catapult

The Medicines Discovery Catapult is a national centre of applied Research and Development expertise, uniquely designed to promote and support innovative, fast-to-patient drug discovery in the UK through collaborative projects.

It is one of a network of elite, not-for-profit technology and innovation centres established by Innovate UK as a long-term investment in the UK's economy. The Medicines Discovery Catapult will work with industry, academic teams, technology experts, charities, regulators and others.

We provide unique scientific capabilities and act as a gateway to specialist facilities, technology and expertise within the UK, supporting SMEs to drive the development of new approaches for the discovery and early development of new medicines. Helping to transform ideas into commercial products and services for the wider health and wealth of the country. By developing and validating new ways of discovering new medicines, and promoting key talent and expertise across sectors, it can help the UK maintain its heritage position as a global leader in this key industry.

About MDC's Lighthouse Lab, Alderley Park

· Testing circa 30,000 COVID-19 samples per day 

· Recently reached the incredible milestone of testing 3 million total COVID-19 samples 

· Increased testing capacity by 25% in September alone and is now delivering approx. 50% of the capacity through automated methods, with that set to increase as it continues to scale

For more information on the Lighthouse Lab Network see: https://www.lighthouselabs.org.uk/