Oxford BioDynamics Checkpoint Inhibitor Response Test (EpiSwitch® CiRT) Now Available in the UK

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

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Prediction of EpiSwitch® CiRT response before treatment (Graphic: Business Wire)

First-of-its-kind EpiSwitch CiRT blood test predicts cancer patient’s likelihood of response to widely used therapeutic class – ICIs – including anti-PD-L1 and anti-PD-1 immunotherapies . Using a routine blood test, rather than an invasive biopsy, CiRT provides rapid, personalized advice to the doctor on expected efficacy, allowing for a more informed decision to start or continue treatment.

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

This UK expansion follows encouraging early adoption 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 licensed physicians.

An estimated 2.9 million people were living with cancer in the UK in 2020, a prevalence rate expected to reach 4 million by 2030 (Macmillan Cancer Support). It is estimated that approximately 350,000 people are diagnosed each year, or more than 1,000 new cases per day (Cancer research in the UK).

Despite the powerful potential efficacy of ICI [2], they have been estimated to be ineffective for up to 70% of treated patients. The situation is exacerbated by the fact that ICIs are among the most expensive drugs in the world. The UK’s best-selling ICI has a list price of £84,000 per patient treatment for the drug alone.

The NHS and private healthcare systems in the UK could save significant sums, estimated at almost £1billion, by avoiding or reducing the rate at which ineffective treatments are given, through simple personalized testing. Savings to the US healthcare system could amount to more than $10 billion.

Dr Geoff Higgins, Honorary Consultant Clinical Oncologist, Oxford University Hospitals NHS Foundation Trust, said: “Immune checkpoint inhibitors are a great advance in cancer treatment, but since many patients fail to respond and the treatment can frequently cause significant side effects, there is a pressing need for robust response biomarkers. The current PD-L1 IHC standard lacks the accuracy desired by many oncologists. There is a significant unmet clinical need to better predict response to ICI 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 IHC PDL-1 testing processes not being highly discriminatory in terms of benefit to some patients for whom immunotherapy is indicated. EpiSwitch CiRT has the potential to solve this testing problem with the introduction of a specific and precise IO [immuno-oncology] response test. There is a great advantage in having a liquid biopsy tool that is less invasive than tumor sampling and can be reassessed longitudinally, while being under treatment at multiple times.

OBD CEO Jon Burrows added: “We understand that in order to provide the highest quality care to cancer patients, clinicians must be able to base their treatment choice decision on meaningful and accurate data. We have already seen in the United States that a simple blood test, such as CiRT, which can predict patient response to ICI, could quickly become an essential tool for clinicians. We are proud to now make it available to UK patients as well. Although initially this will only be available to private healthcare providers, we are also aiming to expand availability through the NHS.

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

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

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

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 checkpoint inhibitor treatments in immuno-oncology (IO), 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 Bay Kit.

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

Oxford BioDynamics has participated in more than 40 partnerships with major pharmaceutical companies 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 assays, bioinformatics tools for 3D genomics, and an expert-curated 3D genome knowledge base comprising hundreds of millions of data points from more than 10,000 samples in more than 30 human diseases.

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

For more information, visit the Company’s website, www.oxfordbiodynamics.comor follow Twitter Where LinkedIn.

References

[1] Hunter E., et al. Development and Validation of Predictive Blood Biomarkers for Response to PD-(L)-1 Checkpoint Inhibitors: Evidence for a Universal Systemic Core of 3D Immunogenetic Profiling in Multiple Oncology Indications. MedRxiv (2021). https://doi.org/10.1101/2021.12.21.21268094

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

[3] Oxford BioDynamics PLC. Oxford BioDynamics’ simple blood test that predicts patient response to immune checkpoint inhibitors was well received at ASCO 2022, June 14, 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 more than 10 years of research, EpiSwitch® is Oxford Biodynamics’ award-winning proprietary platform that enables the screening, evaluation, validation and monitoring of 3D genomic biomarkers. The technology is fully developed, based on testing over 10,000 samples in 30 disease areas, and scaled to practice.

In addition to stratifying patients based on anticipated clinical outcomes, EpiSwitch® data offers insights into systems biology and physiological manifestation of disease beyond the reach of other molecular modalities. The technology has performed well in academic medical research settings and has been validated through its integration into biomarker discovery and clinical development with major pharmaceutical companies.

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