CAMBRIDGE, U.K.—Owlstone Medical, which created 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. Those diseases are systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), asthma and chronic obstructive pulmonary disease (COPD).
As part of this connection with 3TR, Owlstone will receive funds from the project to provide Breath Biopsy collection stations and kits for the collection of breath samples. The company will also provide 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.
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.
The 3TR project unites renowned, interdisciplinary experts from 69 academic and industrial partner institutions, including multiple top-10 pharma companies, covering 15 European countries. Under the initiative, 3TR will reportedly 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.
3TR operates under the umbrella of the Innovative Medicine Initiative 2 (IMI2), and has made it its mission “to fundamentally increase knowledge of the molecular pathways and mechanisms linked to response and non-response to a range of therapies.” The initiative is funded with a total of more than €80 million over the next seven years by IMI2.
Despite the heterogeneity existing among the seven diseases covered by this work, 3TR notes that 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,” said Marta Alarcón-Riquelme, scientific coordinator of 3TR and head of the Medical Genomics program at the GENYO centre at the Fundación Pública Andaluza Progreso y Salud. “In a unique approach, we will study the seven diseases both in parallel and jointly.”
“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,” Alarcón-Riquelme added. “This comprehensive approach will help identify biomarkers to improve patient management within these diseases.”
All data generated within the project will be gathered on a centralized data management platform that 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 expects to “contribute to swiftly translating relevant knowledge and project outcomes into clinics.”
“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,” said Billy Boyle, co-founder and CEO of Owlstone. “3TR’s groundbreaking 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.”
In other recent news from Owlstone, dating back to September, the company announced the introduction of a new ReCIVA Breath Sampler and CASPER Portable Air Supply, designed to support internal biomarker discovery programs and those of academic and biopharma clients, and to measure levels of known volatile organic compounds (VOCs) on breath.
The discovery of biomarkers—whether in blood, tissue or breath—can be difficult, the company notes, and issues can arise throughout the process. Two of the most challenging issues are the impact of background noise and the risk of contamination, and the collection of sufficient levels of chemicals such that they can be measured and changes in their levels detected. Owlstone has focused on addressing these challenges through the development of its proprietary Breath Biopsy platform.
The new CASPER includes a range of benefits over its predecessor, including uniting the airflow pump and filter into a single casing that connects directly to the ReCIVA Breath Sampler, the use of filter cartridges which can be easily replaced, and active warnings when the filter cartridge needs changing or of temperature or airflow issues. The company has also implemented new software to monitor subject breathing and VOC collection through ReCIVA, including a simpler user interface and the ability to set different levels of access to settings for different users. Work is also ongoing to improve the ergonomics, ease-of-use, comfort and robustness of the ReCIVA Breath Sampler.
“Our Breath Biopsy platform and our ability to discover and validate breath-based biomarkers is the foundation of our business, underpinning both our revenue-generating research products and services and our Breath Biopsy test development efforts,” said Boyle at the time of the product launch announcement. “Continued investment in our industry-leading platform is therefore an important component of our strategy.”