Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics's Checkpoint Inhibitor Response Test(EpiSwitch® CiRT) now available in the UK

· EpiSwitch CiRT® is a first-of-its-kind precision medicine test that predicts a patient's likely response to widely used Immune Checkpoint Inhibitor (ICI) therapies.

· The test has shown high sensitivity (93%), specificity (82%), accuracy (85%), and NPV (93%) across 15 cancer indications where ICI treatments are approved.

· The simple clinical blood test is now also available to private physicians across the UK through the dedicated website: myCiRT.com.

· ICIs therapies are ineffective in up to 70% of patients receiving them, resulting in a critical need for early determination of patient response.

· Healthcare savings for the UK NHS and private healthcare over ineffective ICI therapies and subsequent adverse responses could be over £1bn.

Oxford, UK - 21 June 2022 - Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for immune health based on the EpiSwitch® 3D genomics platform, has announced that its flagship Checkpoint inhibitor Response Test (CiRT) clinical blood test is now available to private physicians considering ICI therapy for their patients in the UK.

The first-of-its-kind EpiSwitch CiRT blood test predicts the likelihood of a cancer patient's response to the widely used class of therapeutics - ICIs - including anti-PD-L1 and anti-PD-1 immunotherapies. Using a routine blood test, rather than an invasive biopsy, CiRT provides fast, personalized guidance for a physician on expected efficacy, enabling a more considered decision whether to begin or continue treatment.

The robust EpiSwitch qPCR blood test has demonstrated best-in-class performance, with high sensitivity (93%), specificity (82%), accuracy (85%), and a significant negative predictive value (NPV) of 93% [1], across several ICIs from multiple pharmaceutical companies and more than 15 key oncological indications, including melanoma and lung cancer.

This expansion to the UK follows encouraging early uptake by early adopters of EpiSwitch CiRT in the US where it was first launched in February 2022 as a Laboratory Developed Test (LDT). The CiRT will initially be available as an LDT to private healthcare providers in the UK. It is only available to registered physicians.

An estimated 2.9 million people were living with cancer in the UK in 2020, a prevalence rate expected to rise to 4 million by 2030 (Macmillan Cancer Support). It is estimated that around 350,000 people are diagnosed each year, amounting to over 1,000 new cases per day (Cancer Research UK).

Despite the potential powerful efficacy of ICIs [2], it has been estimated that they are ineffective for up to 70% of patients treated. The situation is exacerbated by ICIs being some of the most highly priced medicines in the world. The bestselling ICI in the UK has a list price of £84,000 per patient course for the drug alone.

The UK's NHS and private healthcare systems could save significant amounts, estimated to be close to £1bn, by avoiding or reducing the administration rate of ineffective treatments, through straightforward personalised testing. Savings for the US healthcare system could amount to more than $10bn.

Dr Geoff Higgins, Honorary Consultant Clinical Oncologist, Oxford University Hospitals NHS Foundation Trust, said: "Immune checkpoint inhibitors are a great advancement in cancer therapy but since many patients do not respond, and as treatment can frequently cause significant side effects, there is a pressing need for robust biomarkers of response. The current standard of PD-L1 IHC lacks the accuracy that many oncologists desire. There is a significant unmet clinical need to better predict response to ICIs for which EpiSwitch CiRT promises to be a valuable addition.

Dr Simon Lord, Consultant Medical Oncologist, Oxford University Hospitals NHS Foundation Trust, commented: "There are significant limitations with current routine PDL-1 IHC testing processes not being highly discriminatory in terms of benefits for certain patients for which immunotherapy is indicated. EpiSwitch CiRT has the potential to address this testing issue with the introduction of a specific and accurate IO [immuno-oncology] response test. There is a great advantage in having a liquid biopsy tool which is less invasive than tumour sampling and can be reassessed in a longitudinal fashion, whilst on treatment at multiple timepoints."

CEO of OBD, Jon Burrows, added: "We understand that in order to provide the best-quality care for cancer patients, clinicians should be able to base their decision of therapy choice on meaningful and accurate data. We have already seen in the US that a simple blood test, such as the CiRT, that can predict the patient response to ICIs, could quickly become an essential tool for clinicians. We are proud to make this now available to UK patients, as well. While initially this is only available to private healthcare providers, we aim to widen availability through the NHS, as well."

OBD recently presented important clinical utility data at on the EpiSwitch CiRT clinical assay's prediction of patient response to ICI therapies, at the American Society of Clinical Oncologists Annual Meeting (ASCO 2022) in Chicago, IL. The test was very well received by oncologists and health care providers from around the world [3]. OBD will be attending and continue to present new data at the ESMO Congress 2022 (Paris) from September 9 to 13, 2022.

For more about EpiSwitch CiRT, and to order the test, please visit www.myCiRT.com.

Read more about the importance of the recently launched CiRT test here.

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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 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.

References

[1] Hunter E., et al. 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). https://doi.org/10.1101/2021.12.21.21268094

[2] Robert, C. A decade of immune-checkpoint inhibitors in cancer therapy. Nat Commun 11, 3801 (2020). https://doi.org/10.1038/s41467-020-17670-y

[3] Oxford BioDynamics PLC. Oxford BioDynamics' simple blood test that predicts patient's response to Immune Checkpoint Inhibitors well received at ASCO 2022, 14 June 2022. https://www.londonstockexchange.com/news-article/OBD/obd-episwitch-cirt-well-received-at-asco-2022/15493474

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.