Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics' simple blood test that predicts patient's response to Immune Checkpoint Inhibitors well received at ASCO 2022

· Immune Checkpoint Inhibitor (ICI) therapies are ineffective in up to 70% of patients receiving them, resulting in a critical need for early determination of patient response.

· EpiSwitch® CiRT is a first-of-its-kind precision medicine test that predicts a patient's likely response to ICI therapies. Accurate prediction of response is expected to save healthcare systems significant amounts due to the high cost of ICIs and subsequent adverse responses.

· The test has shown high sensitivity (93%), specificity (82%) and accuracy (85%) across 15 cancer indications where ICI treatments are available and has seen encouraging uptake by early adopters in the US since launch.

· OBD presented additional data on EpiSwitch CiRT at ASCO 2022 and met numerous practicing clinicians, pharma development teams, hospital systems and healthcare investors interested in the test.

· This simple blood test is now available to millions of cancer patients via their clinicians across the US at the website: myCiRT.com.

Oxford, UK - 14 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, presented additional data at ASCO 2022 on its flagship CiRT clinical assay to predict patient response to ICI therapies, which was well received.

The EpiSwitch® Checkpoint inhibitor Response Test (CiRT) is a simple blood test available to US-based clinicians, enabling them to advise the millions of cancer patients facing the complex choice between powerful immunotherapy treatments, which might have low response rates and immune-related adverse events, and alternative treatment options.

Launched in February 2022 as a Laboratory Developed Test (LDT), EpiSwitch CiRT is available for immediate clinical utilization in the US via the website: myCiRT.com.

Interest in CiRT at ASCO was significant; OBD representatives held positive meetings with 11 pharma teams, two major US hospital networks, National Cancer Institute-designated comprehensive cancer centers, as well as with clinicians and healthcare investors.

"ASCO was a brilliant opportunity to get the attention of oncologists and the oncology community from around the world," said Dr Jon Burrows, OBD's Chief Executive Officer. "As a small British biotech building our commercial profile, we were overwhelmed by the interest in the Company and EpiSwitch CiRT. We had significantly more meetings than anticipated with practicing oncologists, pharma clinical development teams, hospital administrators and healthcare investors, who welcomed information on the potential use and utility of CiRT. It is highly encouraging that we continue to receive enquiries post-ASCO."

ICIs have been approved as first-line (1L) or second-line (2L) of treatment for 15 different cancer indications. They show remarkable efficacy in treating cancer, and oncologists have actively adopted the use of these therapies. Across the approved indications, approximately 40% of all patients are eligible for ICI therapy [1], and within the class of ICIs, anti-PD-1/PDL-1 antibodies have become some of the most widely prescribed and tested anticancer therapies [2].

Despite their potential efficacy, it has been estimated that ICIs are ineffective for up to 70% of patients treated, and these ineffective therapies in the US alone could add over 42% to annual spend. Currently, there are no predictive tools that accurately report the expected efficacy in individual patients.

This results in substantial unnecessary costs in both time and money to healthcare systems - a situation which is exacerbated by the high prices of ICIs, e.g. Keytruda costs approximately $190,000 in the US. It is estimated that annual savings to the US healthcare system through the personalised administration of ICIs following accurate prognosis could amount to as much as $10B+.

OBD's EpiSwitch CiRT blood test has demonstrated best-in-class performance in the prediction of cancer patient response to ICIs, including anti-PD L1 and anti-PD 1, with high sensitivity (93%), specificity (82%), and accuracy (85%) across several ICIs from multiple pharmaceutical companies, in all 15 key oncological indications.

Dr Steve Mamus, a recognized oncologist serving as Medical Director of Oncology/Hematology and founder of the Cancer Center of Sarasota (FL, USA), commented "EpiSwitch CiRT has demonstrated that it can stratify patients in either a high or low response likelihood category with high accuracy. This promises to add real value - both supporting our decision on whether ICI therapy is appropriate for a patient and giving us a rational approach to stop and/or restart therapy at the right time. We need tools such as EpiSwitch CiRT to provide evidence on whether persevering after an irAE (adverse events related to toxicities) is the right call for an individual patient." Read more from Dr Mamus here [3].

For more about EpiSwitch CiRT, 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] Haslam A., et al. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for Immune Checkpoint Inhibitor Drugs. JAMA Netw Open. 2020;3(3):e200423. doi:10.1001/jamanetworkopen.2020.0423

[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] Biotechnology News Magazine, Dr Steven Mamus: Smart Test Promises to Transform How We Recommend and Administer Immunotherapy, 18 Mar 2022, https://biomag1.com/dr-steve-manus-3182

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.