Oxford Biodyn Regulatory News (OBD)

Oxford Biodynamics' Prostate Screening EpiSwitch® blood test significantly enhances overall detection accuracy for at risk men

· Prostate Screening EpiSwitch (PSE) blood test shows significant potential as an accurate and rapid cancer screening diagnostic

· High accuracy (94%), PPV (92%), and NPV (94%) reported in the high-impact, peer-reviewed journal Cancers

· Experts from Oxford Biodynamics, Imperial College London, University of East Anglia, and Imperial College NHS Trust contributed to multi-institutional clinical study

· This published data packet supports commercialization of the EpiSwitch® platform which includes this novel and accurate prostate cancer test

Oxford, UK - 6 February, 2023 - Oxford BioDynamics, Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, announces the publication of compelling results involving OBD's technology in the multi-disciplinary PROSTAGRAM study using blood to detect prostate cancer in an at risk population. These results were referred to in the recent results statement.

The peer-reviewed work, published in the high-impact journal, Cancers, was a collaboration between OBD, Imperial College London, University of East Anglia, and Imperial College National Health Service (NHS) Trust under the direction of the UK's leading prostate cancer experts.

The NHS considers the widely available prostate-specific antigen (PSA) test as inaccurate1. A positive result from a standard PSA test is unreliable and often suggests prostate cancer is present when no cancer exists. The inaccuracy of current screening protocols leads to many men getting unnecessary referrals for expensive MRI scans and highly invasive, medieval biopsies. Only about a quarter of people who have a prostate biopsy due to an elevated PSA level are found to have prostate cancer2.

In the PROSTAGRAM screening pilot study, blood from 147 men enrolled in the study and patients from Imperial College NHS Trust were tested using the standard prostate-specific antigen (PSA) test and an EpiSwitch® prostate cancer classifier, developed by OBD3. The resultant Prostate Screening EpiSwitch® (PSE) blood test, which combines the PSA component and the EpiSwitch classifier, demonstrated a remarkable 92%:94% positive:negative predictive value and an accuracy of 94%.

As a rapid and minimally invasive test, the highly accurate PSE blood test has unprecedented potential as a screening diagnostic that can minimise unnecessary referrals to expensive and invasive procedures.

Principal investigator Mathias Winkler, M.D., F.R.C.S., Consultant Urologist and Surgeon, Charing Cross Hospital and Imperial College London, said: "The EpiSwitch® PSE results from this study have significant clinical relevance. We are looking forward to working with OBD to complete all the follow-up steps introducing it to clinical practice, bringing this valuable EpiSwitch® tool into the hands of clinicians."

First author Prof. Dmitry Pchejetski, Ph.D., Professorial Research Fellow and Head of the Tumour Microenvironment and Chemotherapy group at Norwich Medical School, said: "When tested in the context of screening a population at risk, the EpiSwitch® PSE test yields a rapid and minimally invasive prostate cancer diagnosis with impressive performance, which suggests a real benefit for both diagnostic and screening purposes."

The peer-reviewed manuscript, titled "Circulating chromosome conformation signatures significantly enhance PSA positive predicting value and overall accuracy for prostate cancer detection," is available online in Cancers4 https://doi.org/10.3390/cancers15030821.

The accurate, rapid, minimally invasive, and cost-effective PSE test was built using OBD's EpiSwitch® 3D genomics platform and methodology. For each patient, PSE captures a personal, systemic fingerprint of specific regulatory network changes associated with prostate cancer.

"OBD's EpiSwitch® 3D genomics platform has once again demonstrated the ability to provide a clinically important diagnostic solution to the global medical community; this time as a highly relevant screening test for prostate cancer," said Dr Jon Burrows, OBD's Chief Executive Officer. "There is a clear need in everyday clinical practice for a highly accurate (94%) blood test that can screen men for prostate cancer and accurately identify those at risk, while sparing those who up to now would be subject to unnecessary, expensive and invasive procedures. This is another example of how OBD's product portfolio can contribute to reducing the total cost of care for global health."

This work follows OBD's first EpiSwitch test in oncology: the EpiSwitch CiRT (Checkpoint inhibitor Response Test), commercially available in the US and UK as an LDT CLIA test5. The first-of-its-kind CiRT test predicts, with 85% accuracy6, an individual patient's likely therapeutic response to immune checkpoint inhibitors (ICIs), a family of widely used immunotherapies that can give some patients a real boost to their cancer recovery and survival.

References

[1] NHS Health A to Z. Prostate cancer: PSA testing (2021). https://www.nhs.uk/conditions/prostate-cancer/psa-testing

[2] Barry, M. J. (2001). Prostate-Specific-Antigen Testing for Early Diagnosis of Prostate Cancer. New England Journal of Medicine, 344(18). https://doi.org/10.1056/nejm200105033441806

[3] lshaker, H., et al. (2021). Chromatin conformation changes in peripheral blood can detect prostate cancer and stratify disease risk groups. Journal of Translational Medicine, 19(1). https://doi.org/10.1186/s12967-021-02710-y

[4] Pchejetski, D., et al. (2023). Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection. Cancers, 15(3), 821. http://dx.doi.org/10.3390/cancers15030821

[5] Oxford BioDynamics Plc. (2022). EpiSwitch CiRT. https://www.mycirt.com

[6] Hunter, E., et al. (2021). Development and validation of blood-based predictive biomarkers for response to PD-(L)-1 checkpoint inhibitors: evidence of a universal systemic core of 3D immunogenetic profiling across multiple oncological indications. MedRxiv, 2021.12.21.21268094.

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About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is a global biotechnology company, advancing personalized healthcare by developing and commercializing precision medicine tests for life-changing diseases.

Its flagship product is EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) for cancer, a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments, launched in February 2022.

In March 2021, the Company launched its first commercial prognostic test, EpiSwitch® CST (Covid Severity Test) and the first commercially available microarray kit for high-resolution 3D genome profiling and biomarker discovery, EpiSwitch® Explorer Array Kit.

The Company has developed a proprietary 3D genomic biomarker platform, EpiSwitch®, which can build molecular diagnostic classifiers for prediction of response to therapy, patient prognosis, disease diagnosis and subtyping, and residual disease monitoring in a wide range of indications.

Oxford BioDynamics has participated in more than 40 partnerships with big pharma and leading institutions including Pfizer, EMD Serono, Genentech, Roche, Biogen, Mayo Clinic, Massachusetts General Hospital and Mitsubishi Tanabe Pharma.

The Company has created a valuable technology portfolio, including biomarker arrays, molecular diagnostic tests, bioinformatic tools for 3D genomics and an expertly curated 3D genome knowledgebase comprising hundreds of millions of data points from over 10,000 samples in more than 30 human diseases.

OBD is headquartered in Oxford, UK and is listed on AIM of the London Stock Exchange. It also has a commercial office in Gaithersburg, MD, USA and a reference laboratory in Penang, Malaysia.

For more information, please visit the Company's website, www.oxfordbiodynamics.com, or follow on Twitter or LinkedIn.

About EpiSwitch®

The 3D configuration of the genome plays a crucial role in gene regulation. By mapping this architecture and identifying abnormal configurations, EpiSwitch® can be used to diagnose patients or determine how individuals might respond to a disease or treatment.

Built on over 10 years of research, EpiSwitch® is Oxford Biodynamics' award-winning, proprietary platform that enables screening, evaluation, validation and monitoring of 3D genomic biomarkers. The technology is fully developed, based on testing of over 10,000 samples in 30 disease areas, and reduced to practice.

In addition to stratifying patients with respect to anticipated clinical outcome, EpiSwitch® data offer insights into systems biology and the physiological manifestation of disease that are beyond the scope of other molecular modalities. The technology has performed well in academic medical research settings and has been validated through its integration in biomarker discovery and clinical development with big pharma.