Owlstone Medical Recruits First Patient in Phase 2 Clinical Trial for the Early Detection of Lung Cancer through Breath Biopsy®

• EVOLUTION Phase 2 trial follows successful Phase 1 demonstration of proof of concept for a lung cancer screening test and safety of probe
• Phase 2 study to focus on assessing diagnostic accuracy and optimizing test performance

Cambridge, UK, October 10, 2023: Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy^® for applications in early disease detection and precision medicine, today announced recruitment of the first patient into its EVOLUTION Phase 2 clinical trial following successful achievement of key safety and proof of concept milestones in Phase 1. The trial has been designed to support the development of a breath test to address the unmet clinical need for more effective early detection of lung cancer through the screening of high-risk asymptomatic individuals.

In the EVOLUTION trial, diagnostic potential of D5-ethyl-βD-glucuronide (D5-EthGlu) as an exogenous volatile organic compound (EVOC^®) probe for detection of lung cancer is being evaluated. This probe is metabolized by β-glucuronidase, an enzyme found in the tumor microenvironment around lung cancer cells, into D5-ethanol serving as a unique biomarker of lung cancer on exhaled breath. Potential also exists for the test to be used to differentiate benign from malignant lung nodules identified through incidental findings or low dose computed tomography (LDCT) screening.

The Phase 2 clinical trial will assess the diagnostic performance of the test and will enable its optimization through refinement of the testing protocol. Supporting this, the study has been designed to allow differentiation between individuals with lung cancer and relevant contrast groups (e.g. COPD) representative of the clinical populations in which the test is intended to be used. This phase of the trial will recruit up to 150 cases and 200 controls from 3 sites in Europe and 6 sites in the U.K. including Royal Papworth Hospital, Cambridge, and Norfolk and Norwich University Hospital where Professor Eleanor Mishras’ team recruited the first patient.

Previous work has demonstrated the ability to detect D5-ethanol on breath in human cancer xenografted mice and established the presence of extracellular β-glucuronidase in tissue samples from early-stage human lung cancers. Phase 1 of the EVOLUTION¹ study showed excellent safety and tolerability of the probe, provided guidance on optimal dose and sampling time, and demonstrated in-human proof of mechanism for the release of D5-ethanol on breath following probe administration in the presence of lung cancers as early as stage 1².

Professor Robert Rintoul, Professor of Thoracic Oncology, University of Cambridge and Honorary Consultant Respiratory Physician, Royal Papworth Hospital, commented: “The best way to increase the current poor survival probabilities for patients with lung cancer is to detect the disease early when it can be treated with curative intent by surgery or radiotherapy.  Low dose CT (LDCT) for lung cancer screening has been shown to detect more cancers at an early stage, increase survival rates and be cost-effective.  An effective breath test for lung cancer could further increase the efficacy, reach and accessibility of lung cancer screening.”

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Results from Phase 1 of the EVOLUTION trial demonstrated the relevance of the molecular pathway targeted by D5-EthGlu and provided crucial evidence to support further test development. With the recruitment of the first patient into Phase 2, we are excited to continue to progress a test that has the potential to transform lung cancer diagnosis by substantially increasing the uptake of testing, leading to more cases of lung cancer being caught early and significantly reducing mortality and costs. Our nodule management test also holds the potential for more effective identification of benign nodules, reducing unnecessary biopsies and surgery.”

Lung cancer is one of the most common forms of cancer in the world with 2.2 million new cases in 2020 and is a leading cause of death (1.8 million globally in 2020³), with 5-year survival at 25% in the United States⁴ and just 15% in the U.K.⁵ Early diagnosis can greatly improve the clinical outlook as patients diagnosed at an early stage have a 5-year survival rate of 56%, compared to just 5% for late stage⁶. While there are guidelines in place for the use of LDCT in the United States, and a similar program is being launched in the U.K.⁷, uptake is less than 6%⁸ due to inconvenience, radiation dose, test performance, and in some cases cost. For this reason, there is an acute need for reliable and non-invasive screening solutions, and breath has emerged as a highly promising potential solution.

References:

1.       https://classic.clinicaltrials.gov/ct2/show/NCT05510674?term=evolution+lung+cancer+evoc&draw=2&rank=1 

2.       https://www.owlstonemedical.com/about/news/2023/jun/14/owlstone-medical-presents-data-demonstrating-progr/ 

3.       https://www.who.int/news-room/fact-sheets/detail/cancer

4.       https://www.lung.org/research/state-of-lung-cancer/key-findings  

5.       https://www.cancerresearchuk.org/about-cancer/lung-cancer/survival 

6.       http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet.html  

7.       https://www.gov.uk/government/news/new-lung-cancer-screening-roll-out-to-detect-cancer-sooner 

8.       https://www.lung.org/media/press-releases/state-of-lung-cancer-2022 

ENDS

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What is Breath Biopsy^® (https://www.owlstonemedical.com/science-technology/breath-biopsy/):

Breath Biopsy represents an entirely new way to determine the chemical makeup of breath by measuring volatile organic compounds (VOCs), gaseous molecules that can be sampled quickly and non-invasively. VOCs originate from all parts of the body as the end product of metabolic processes, making Breath Biopsy applicable to a wide range of diseases including lung cancer, liver disease, and digestive disease. Breath also contains microscopic aerosol particles from the lungs and airways, which can contain a wide range of biomarkers including for infectious disease. The nature of Breath Biopsy therefore makes it perfectly suited to addressing two of the major challenges of healthcare today: early detection of disease and precision medicine.

About EVOC^® Probes (https://www.owlstonemedical.com/science-technology/evoc-probes/):

Exogenous VOC (EVOC) Probes are a reliable and highly sensitive alternative to the detection of endogenous biomarkers, as is standard in liquid biopsy, which are often found at very low levels and so are difficult to detect in early disease. EVOC Probes instead are engineered to release a volatile reporter on breath after cleavage by a specific target pathway. This approach offers the advantage that compounds not normally found at significant levels in breath can be introduced into the body (individually or as a cocktail) to explore how they are absorbed, metabolized or excreted. Further, high levels can be administered, substantially improving signal-to-noise ratios compared to signals from endogenous sources and thus greatly improving reliability of detection.

About Owlstone Medical (www.owlstonemedical.com):

Owlstone Medical’s vision is to save 100,000 lives by realizing the enormous promise of breath-based diagnostics through the development and application of Breath Biopsy®, a unique platform capable of both biomarker discovery and use in routine clinical testing.

The 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, U.K., and the Breath Biopsy VOC Atlas, the most extensive catalogue of identified volatile organic compounds (VOCs) commonly found on breath. The Company’s technology is protected by over 140 granted and pending patents and has been used in more 100 research papers.

Owlstone Medical’s Research Products and Services are being deployed at over 100 sites around the world with large pharmaceutical companies including AstraZeneca, Actelion (a J&J company), GlaxoSmithKline, and leading academic institutions. Projects are supported by Breath Biopsy OMNI^®, the most advanced solution for reliable end-to-end global breath VOC analysis, which is helping researchers advance biomarker discovery and disease research and maximizing the chances of finding clinically relevant breath biomarkers. 

The Company has a portfolio of Breath Biopsy tests in development for the early detection of lung cancer and liver disease, both areas of high unmet clinical need that represent multi-billion dollar market opportunities. In digestive health, under the OMED Health brand, clinical tests for Small Intestinal Bacterial Overgrowth and carbohydrate malabsorption are on market in the U.K., and a handheld device and app for longitudinal monitoring of digestive health is in development.