Owlstone Medical to Contribute Breath Biopsy to 3TR, the Largest-ever IMI2 Immunology Project to Improve Disease Management Across Seven Immune-Mediated Diseases

• Large-scale public-private research initiative designed to provide new insights into the mechanisms of response and non-response to treatment within and across seven different immune-mediated diseases
• Owlstone Medical will receive funding to provide breath component of multi-dimensional molecular analysis of patient samples, initially expected to focus on asthma and chronic obstructive pulmonary disease (COPD)
• 3TR is funded with a total of more than €80m over the next seven years by Innovative Medicine Initiative 2 (IMI2) – a joint undertaking of the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA)

Cambridge, UK, October 29 2019: Owlstone Medical, the global leader in Breath Biopsy® for applications in early disease detection and precision medicine has joined 3TR, a large-scale public-private research initiative that aims to provide new insights into the mechanisms of response and non-response to treatment within and across seven different immune-mediated diseases. Owlstone Medical will receive funds from the project to provide Breath Biopsy Collection Stations and Kits for the collection of breath samples, and analysis services for multiple studies that have been identified at this stage as suitable to include breath sampling, alongside clinical and physiological evaluation and blood analysis.

The project unites renowned, interdisciplinary experts from 69 academic and industrial partner institutions, including multiple top-ten pharma, covering 15 European countries. Under the initiative, 3TR will have access to an unprecedented quantity of clinical data and samples of more than 50,000 patients across 50 ongoing and new clinical trials, ultimately aiming to discover and verify stratification biomarkers to improve patient management.

Autoimmune, inflammatory and allergic diseases are common chronic diseases that significantly affect the wellbeing of millions of people around the globe and pose a substantial burden to healthcare systems. While different treatments are available, response and disease progression in individual patients remain unpredictable, which can hamper the management of their disease.

In a never-before-seen effort to bring together experts from different medical fields, profiling technologies, systems biology and bioinformatics with specialists from innovative SMEs and leading pharmaceutical companies, 3TR – operating under the IMI2 umbrella – sets out to fundamentally increase knowledge of the molecular pathways and mechanisms linked to response and non-response to a range of therapies. The work falls within and across seven different immune-mediated, allergic and inflammatory diseases - systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), asthma and COPD. Despite their heterogeneity, recent studies have shown that on the molecular level certain patterns are shared by patients across these diseases, thus suggesting they may also share pathways of response to treatment and disease progression.

Breath sampling is expected to be deployed initially into multiple academic-led trials for asthma and COPD, however the potential exists for Breath Biopsy to extend into additional studies in other investigational areas as the 3TR initiative proceeds. Owlstone Medical will have full access to the data generated, and the rights to develop biomarkers discovered into clinical tests.

“For the first time, the 3TR team will align and integrate the analysis of autoimmune, allergic, and inflammatory conditions to identify the relationship between longitudinal molecular and microbiome profiles in blood cells and tissues, and disease paths. In a unique approach we will study the seven diseases both in parallel and jointly”, explains Marta Alarcón-Riquelme, scientific coordinator of 3TR and Head of Medical Genomics at the GENYO centre at the Fundación Pública Andaluza Progreso y Salud. “We believe that this high-resolution multi-omics profiling analysis of individualized response to treatment and disease progression will facilitate stratification and identification of molecular patterns that better predict response or non-response to therapy. This comprehensive approach will help identify biomarkers to improve patient management within these diseases.”

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Currently, too little is known about the molecular basis underpinning autoimmune, inflammatory, and allergic diseases. A deeper understanding of the cellular mechanisms driving disease development is urgently needed, which will support the discovery of novel biomarkers, on breath or other sample types that can be deployed to detect disease earlier and to drive improved patient outcomes. 3TR’s ground-breaking approach to addressing this problem through integrated cross-disease analysis, led by leading academic, pharmaceutical, and other organizations, is one that Owlstone Medical is excited to be making a unique contribution to.”

All data generated within the project will be gathered on a centralized data management platform. The latter will enable detailed and comprehensive, state-of-the-art bioinformatics and biostatistics analyses based on machine learning and dynamic, mechanistic methods. By involving medical associations in close relationship with patient groups, 3TR will also contribute to swiftly translating relevant knowledge and project outcomes into clinics.

The 3TR team will officially kick off their activities with a first meeting in Granada, Spain from 30-31 October 2019.

ENDS

Notes to Editors:

For more information on Owlstone Medical please contact:
Grace Holland, Zyme Communications
grace.holland@zymecommunications.com
+44 (0) 7530 386228

Or

Frazer Hall, Citigate Dewe Rogerson
frazer.hall@citigatedewerogerson.com
+44 (0) 20 7282 2822

For more information on 3TR, please contact:
Prof. Marta E. Alarcón-Riquelme, Project Coordinator
GENYO centre at the Fundación Pública Andaluza Progreso y Salud (FPS)
marta.alarcon@genyo.es
+34 (958) 715 500-113

About 3TR

3TR brings together 69 partner organisations from 15 European member states including academic and research institutions, small and medium-sized enterprises (SME) and pharmaceutical companies. For a full partner list, please visit: www.3tr-imi.eu

The project is supported with a funding of over € 80 million from the Innovative Medicines Initiative 2 (IMI2), a joint undertaking of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Visit the 3TR website: www.3tr-imi.eu

Follow 3TR on Twitter: @3TR_IMI

Project Facts

Full Project Title: Taxonomy, Treatment, Targets and Remission. Identification of the

Molecular Mechanisms of non-response to Treatments, Relapses and

Remission in Autoimmune, Inflammatory, and Allergic Conditions

Project Acronym: 3TR

Start Date: 01.09.2019

Duration: 84 months

Budget: 80,648,441.50 €

Coordination: Fundación Pública Andaluza Progreso y Salud (FPS)

Project Lead: Sanofi-Aventis Deutschland GmbH (SANOFI)

About Owlstone Medical (www.owlstonemedical.com):

Owlstone Medical’s vision is to save 100,000 lives and $1.5 billion in healthcare costs by realizing the enormous promise of breath-based diagnostics through the development and application of Breath Biopsy®. Breath Biopsy operates by detecting volatile organic compounds (VOCs) produced as the end product of metabolic processes within the body or as a result of chemicals from external sources such as diet or medication, changes in which can be characteristic of specific disease or indicate environmental exposure.

The Breath Biopsy platform includes ReCIVA®, a proprietary sample collection device that can take stable breath samples anywhere, the world’s only commercial Breath Biopsy Laboratory located in Cambridge, UK, and the development of the world’s largest Digital Breath Biobank matched to patient phenotype.

Owlstone Medical is deploying the platform to address some of the key challenges of 21st century healthcare. The focus is on the early detection of disease with an emphasis on cancer, with clinical trials underway to develop breath tests for the early detection of lung and colorectal cancer, and on precision medicine through partnerships with large pharmaceutical companies including AstraZeneca, Actelion Pharmaceuticals (a J&J company), and GlaxoSmithKline to enable therapeutics to be deployed more effectively. Owlstone Medical’s technology is currently in use at over 100 sites worldwide.

About IMI

The Innovative Medicines Initiative (IMI) is Europe’s largest public-private initiative aiming to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. IMI facilitates collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. It is a partnership between the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations).

For further information: www.imi.europa.eu