Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics Plc

Bupa UK to cover EpiSwitch® CiRT for customers with cancer

· Bupa UK health insurance customers being considered for checkpoint inhibitor immunotherapy will now be offered the smart blood test, which accurately predicts a cancer patient's response to the treatment

· The OBD Bupa UK partnership significantly enhances access to CiRT in the UK and reflects Bupa's commitment to leveraging advanced precision medicine testing to transform cancer care

Oxford, UK - 18 October, 2023 - Oxford BioDynamics, Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform and Bupa, the UK's leading health insurer, announce a strategic agreement to give Bupa patients access to OBD's EpiSwitch CiRT (Checkpoint inhibitor Response Test).

The EpiSwitch CiRT is a first-of-its-kind blood test that accurately predicts an individual cancer patient's therapeutic response to immune checkpoint inhibitors (ICIs), providing unique benefits for physicians in treatment planning and navigating complex decisions [1,2]. ICIs offer a real hope of durable disease control for some patients. Despite pre-screening with current standard tests such as tumor PD-L1 expression, these costly ICIs offer a long-term survival advantage to less than 1 in 4 patients [3], and many may become seriously ill and require hospital admission.

Under this new agreement between Bupa and OBD, Bupa health insurance customers who are being considered for immunotherapy with an anti-PD-1/L1 ICI will be offered the CiRT test, ensuring their doctor receives state-of-the-art personalized guidance to inform their treatment plan. The partnership underscores the shared vision of Bupa and OBD to improve the quality of patient care, while sparing many individuals from unwarranted side effects from ICI treatments that are ineffective for them.

The CiRT test will also be available to doctors considering treating Bupa customers with an ICI, where decisions need to be made in the face of potential serious illness and lack of response to treatment.

Tim Woodman, Medical Director at Bupa UK Insurance, said: "We're very pleased to launch our partnership with Oxford BioDynamics which will give our customers a leap in confidence when navigating complex decisions about their therapy.

"This agreement reflects our commitment to leverage advanced precision medicine testing to transform cancer care and provide doctors with the tools they need to make informed decisions. Together with Oxford BioDynamics, we aim to make a positive impact on the lives of all our customers living with cancer."

Dr Jon Burrows, Chief Executive Officer of Oxford BioDynamics, said: "Joining forces with a pioneering healthcare organization like Bupa will enhance access to the EpiSwitch CiRT test across the UK. Gaining reimbursement from the UK's leading health insurer is another milestone for the Company, as well as for Bupa customers and their doctors.

"Current testing modalities lack the sensitivity, specificity and accuracy to identify those most likely to benefit from this class of therapy - the CiRT blood test is a first-of-its-kind test that addresses all of these shortcomings."

This news follows EpiSwitch CiRT's sustained adoption in the US [4], where a unique CPT PLA reimbursement code for the test has been available for use by US payors since October 2022.

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References

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

[2] 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://www.mdpi.com/2072-6694/15/10/2696

[3] Zhao, B.; Zhao, H.; Zhao, J. (2020). Efficacy of PD-1/PD-L1 blockade monotherapy in clinical trials, Therapeutic Advances in Medical Oncology, Vol. 12. https://doi.org/10.1177/1758835920937612

[4] Oxford BioDynamics Plc. (2023). Half-year report. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1690889

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Notes to 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 has been 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 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.

About Bupa UK

Bupa's purpose is helping people live longer, healthier, happier lives and making a better world. Health insurance accounts for a large part of our business with Bupa UK Insurance, the UK's leading health insurer, providing health and dental insurance to over 3 million people. Bupa Global is the premium health insurance arm of Bupa, serving 460,000 customers around the world. Bupa Dental Care is the leading provider of dentistry in the UK, providing dental services in 475 centres across the UK and Ireland. Bupa Care Services has around 6,600 residents in over 121 care homes, and 10 Richmond care villages. Bupa Health Services comprises 52 health clinics, and the Cromwell Hospital in London which provides care for insured, self-pay and international patients. Bupa directly employs around 23,000 people in the UK.