Study Data Show Progress in Development of Breath Test for Lung Cancer

Owlstone Medical is sharing new data on the development of a screening test for the early lung cancer detection. 
 
The poster “Proof-of-mechanism study for a diagnostic probe compound generating D5-ethanol as an on-breath reporter molecule for lung cancer – Evolution phase 1” describes Owlstone’s efforts to establish D5-ethyl-ß-glucuronide as a non-invasive EVOC Probe for early cancer detection. Previous work, described in the poster, has demonstrated the ability to detect D5-ethanol cleaved from the probe through the action of extracellular ß-glucuronidase in human cancer xenografted mice. Subsequently, Owlstone Medical established the presence of extracellular ß-glucuronidase in tissue samples from human lung cancers, including at stage 1, and the ability to reliably detect D5-ethanol in human breath samples through Breath Biopsy after administration of the EVOC probe.
 
In-human clinical trials are now underway with Phase 1a (safety assessment in healthy humans) and Phase 1b (dose optimization study in subjects with and without lung cancer) of the EVOLUTION study almost complete. Preliminary results show excellent safety and tolerability and demonstrate proof of mechanism through successful D5-Ethanol levels measurements in breath samples from lung cancer patients .
 
The poster “Using exogenous volatile organic compound (EVOC) probes to target tumour-associated aldo-keto reductase activity: a potential tool to detect lung cancer” describes a complementary EVOC probe approach for the early lung cancer detection based on aldo-keto reductase (AKR) activity, a metabolic process linked with the body’s reaction to the damaging effects of high oxidative stress levels from cancer. This study, performed in-vitro on human lung cancer cells, evaluated the expression of AKRs and demonstrated the ability to measure AKR-associated volatile reporters from cancer cells.
 
“Through the studies presented, we are now confident we have the evidence we need to proceed to Phase 2 of the EVOLUTION study” Owlstone Medical Co-Founder/CEO Billy Boyle said. “This new multisite international trial will recruit up to 150 cases and 200 controls to optimize the test protocol and to establish test performance. We are also encouraged that a number of additional promising complementary EVOC probes are in our development pipeline, further enhancing our ability to address this high clinical need area.”
 
Lung cancer is one of the world’s most common cancers, with 2.21 million new cases in 2020. It is a leading cause of death (1.8 million globally in 2020¹), with five-year survival at just 23.7% in the United States.² Early diagnosis can greatly improve the clinical outlook as patients diagnosed at an early stage have a five-year survival rate of 56%, compared to just 5% for late stage.³ While there are guidelines in place for the use of low-dose computed tomography in the United States, uptake is less than 6%⁴ 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.
 
The posters can be viewed here:
https://www.owlstonemedical.com/media/uploads/files/2023-05_Evolution_Poster_for_EACR_v2.pdf
https://www.owlstonemedical.com/media/uploads/files/2023-05_AKR_Poster_for_EACRv2.pdf
 
Breath Biopsy represents a 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 body parts 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.
 
Owlstone Medical’s Breath Biopsy is a 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 more than 120 granted and pending patents and has been used in over 100 research papers. Owlstone Medical’s Research Products and Services are being deployed at more than 100 sites worldwide with large pharmaceutical companies including AstraZeneca, Actelion (a J&J company), and 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 an active portfolio of Breath Biopsy tests in development for the early lung cancer and liver disease detection. In digestive health, clinical tests for small intestinal bacterial overgrowth and carbohydrate malabsorption are already on the market, and breath testing is emerging as an effective way for patients to monitor and manage symptoms.

References
¹ https://www.who.int/news-room/fact-sheets/detail/cancer
² https://www.lung.org/research/state-of-lung-cancer/key-findings 
³ http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet.html
⁴ https://www.lung.org/media/press-releases/state-of-lung-cancer-2022