Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics ("OBD" or the "Company" and, together with its subsidiaries, the "Group")

Oxford BioDynamics partners with The London Clinic to offerEpiSwitch® PSE and CiRT oncology tests

· The London Clinic is one of the UK's largest private hospitals, situated in London's Harley Street medical district

· OBD's EpiSwitch PSE and CiRT tests will be added to The London Clinic's oncology toolbox

· Agreement provides physician and patient access to EpiSwitch diagnostic tests at the newly opened state-of-the-art Rapid Diagnostics Centre

Oxford, UK - 21 May 2024 - Oxford BioDynamics Plc (AIM: OBD, the "Company"), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, and The London Clinic, one of the UK's leading private hospitals, have signed an agreement to give The London Clinic patients access to OBD's EpiSwitch PSE (EpiSwitch Prostate Screening) and EpiSwitch CiRT (Checkpoint inhibitor Response Test) blood tests.

The London Clinic is the UK's largest independent charitable hospital, situated in London's renowned medical district at Harley Street. The organisation works with all major UK and many international private medical insurers, with its doctors treating around 155 different conditions. The integration of OBD's EpiSwitch PSE test into The London Clinic's suite of oncology diagnostics aligns with the recent opening of its state-of-the-art six-floor Rapid Diagnostics Centre opposite its main hospital.

"We know that cancer treatment outcomes are hugely influenced by accurate and early diagnosis, and it's crucial we give our doctors the tools they need to predict if patients will respond to potentially life-saving medicines. The qualities of OBD's accurate PSE and CiRT tests align with our commitment to providing cutting-edge innovation and excellence in personalised patient care. Both of these tests can play an important part in helping our doctors and patients save valuable time in making an informed decision about their health, and getting on track to receiving the required care," said Dr Rowan Miller, Clinical Director for Oncology at The London Clinic.

OBD's EpiSwitch PSE test is a blood test that boosts the predictive accuracy of a standard PSA test from 55% to 94% when testing for the presence or absence of prostate cancer, which was launched in the UK and US in September 2023 (see www.94percent.com). The PSE test is the culmination of nearly ten years of collaborative work between OBD, Imperial College London, the University of East Anglia, Imperial College NHS Trust, and leading UK prostate cancer experts, as part of the PROSTAGRAM screening pilot. As well as a high 94% accuracy, PSE offers high specificity, 97% (standard PSA alone: 53%), and high sensitivity, 86% (PSA: 64%), as well as high positive, 93% (PSA: 25%1), and high negative, 95% (PSA: 86%1) predictive values to assess the risk of prostate cancer in men, published in the peer-reviewed publication, Cancers2.

The EpiSwitch CiRT test will be available to The London Clinic doctors considering treating their cancer patients with a widely used class of cancer therapies: Immune Checkpoint Inhibitors (ICIs)3. CiRT is a routine blood test that accurately identifies patients who will respond to ICI therapy with a binary result (responder vs. non-responder) to support first-line treatment planning, and make more informed treatment decisions when no benefit or disease progression is observed, or adverse events occur. The test can also identify ICI candidates in patients where other options have been exhausted or other tests are negative for use (see www.myCiRT.com).

Dr Jon Burrows, Chief Executive Officer of Oxford BioDynamics, said: "There is a clear need for more accurate, minimally-invasive blood tests for detecting prostate cancer and predicting response to immunotherapy. Through this new partnership with The London Clinic we are delivering potentially life-changing blood tests, which can safeguard the wellbeing of at-risk patients whilst reducing the cost of care. This agreement follows our earlier joint announcement with Bupa UK to provide coverage for the EpiSwitch CiRT test. Joining forces with a world-class hospital like The London Clinic will enhance access to the EpiSwitch PSE and CiRT tests in a centre of excellence in the heart of London."

References

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

2. Pchejetski D, Hunter E, Dezfouli M, et al. (2023). Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection. Cancers. 2023; 15(3):821. https://doi.org/10.3390/cancers15030821

3. Hunter, E., et al. (2023). Development and validation of blood‐based predictive biomarkers for response to PD‐1/PD-L1 checkpoint inhibitors: evidence of a universal systemic core of 3D immunogenetic profiling across multiple oncological indications, Cancers 15(10), 2696. https://doi.org/10.3390/cancers15102696

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Notes for Editors

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 products are the EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) and EpiSwitch® PSE (EpiSwitch Prostate Screening test) blood tests. CiRT is a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments, launched in February 2022. PSE is a blood test that boosts the predictive accuracy of a PSA test from 55% to 94% when testing the presence or absence of prostate cancer, which was launched in the US and UK in September 2023.

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, which is available for purchase by the life science research community.

The Company's product portfolio is based on a proprietary 3D genomic biomarker platform, EpiSwitch®, which can build molecular diagnostic classifiers for the 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 15,000 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 and a clinical laboratory in Frederick, MD, USA, and a reference laboratory in Penang, Malaysia.

For more information, please visit the Company's website, www.oxfordbiodynamics.com, or follow OBD on Twitter (@OxBioDynamics) and LinkedIn.

About The London Clinic

The London Clinic is a leading private charitable hospital, situated in Harley Street, the heart of London's medical district. Opened in February 1932 by the Duke and Duchess of York (later becoming King George VI), The London Clinic has been at the forefront of healthcare for over 90 years.

Her Majesty The Queen (formerly HRH The Duchess of Cornwall) is The London Clinic's Patron.

The London Clinic's services are provided across seven buildings housing eleven theatres, 190 beds, consulting rooms, and a wide range of diagnostic services, including the latest 3T MRI scanner. The Duchess of Devonshire Wing, The London Clinic's custom-built cancer centre, spans eight floors, offering access to state-of-the-art radiotherapy and chemotherapy suites, along with Europe's largest private stem cell collection and storage facility. We were the first independent hospital in the UK to gain the Joint Accreditation Committee ISCT Europe and EBMT (JACIE) accreditation in recognition of our quality standards in stem cell work. We also have a Rapid Diagnostics Centre (opened February 2024) which focuses on urology, gynaecology, breast and dermatology, as well as supports a focus on early diagnosis particularly in cancer.

As a full-service hospital, The London Clinic offers the most comprehensive range of services of any UK private hospital, including a 13-bed, Level 3 Intensive Care Unit and in-house pathology laboratory. We employ over 1,300 expert nurses, allied healthcare professionals, doctors, and support roles. Our 900 world-class consultants specialise in cancer care, digestive diseases, orthopaedics (including hips, knees, shoulders, and fingers with on-site physiotherapy rehabilitation), neurology, cosmetic surgery, liver services, gastroenterology, urology, endoscopy, diabetes, haematology, and endocrinology.

As a charity, The London Clinic reinvests all profits to further our mission of advancing healthcare within our hospital and for the benefit of the healthcare community. We were the first private hospital in the UK to introduce robotic surgery for prostate cancer and SpyGlass technology for endoscopy. We continue to invest significantly in the education of our people, supporting nurses to complete their degrees and fellows to become consultants. 

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 15,000 samples in 30 disease areas, and reduced to practice.

In addition to stratifying patients with respect to anticipated clinical outcomes, 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.