Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics confirms availability of EpiSwitch® CST (COVID Severity Test)and provides update on clinical validation of EpiSwitch® CiRT(Checkpoint Inhibitor Response Test)

Oxford, UK - 17 December 2021 - Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for immune health based on the EpiSwitch® 3D genomics platform, provides an update on both its EpiSwitch® CST (COVID Severity Test) and EpiSwitch® CiRT (Checkpoint Inhibitor Response Test).

EpiSwitch® CST (COVID Severity Test)

OBD is pleased to confirm that, further to the announcement made on 25 October 2021, its EpiSwitch® CST (COVID Severity Test) is available in the US. COVID-19 remains a global concern and an ongoing pandemic. With the resurgence of COVID, specifically the delta and omicron variants, interest in EpiSwitch® CST has been increasing and the Company has launched a new digital marketing campaign to raise awareness of the availability of the test. EpiSwitch® CST can identify those with the greatest risk of experiencing critical, life-threatening disease because of a SARS-Cov-2 viral infection.

EpiSwitch® CiRT (Checkpoint inhibitor Response Test)

EpiSwitch® CiRT is a blood-based predictive test of a patient's likely response to checkpoint inhibitor therapies to treat certain cancers, offering valuable insight for oncologists and payors alike.

In 2019, in the US, approximately $14bn was spent on checkpoint inhibitor therapies, with 300,000 patients receiving treatment with these drugs. However, on average fewer than one third of such patients were likely to benefit from this treatment. A significant proportion of people will experience an adverse reaction to the therapy, but some of these will see a clinical benefit if they continue after being treated for the reaction. As such, knowing the likelihood of response assists doctors in deciding on the appropriate course of treatment, including for patients who show significant adverse reactions but who should be treated and encouraged to continue with checkpoint inhibitor therapies.

Clinical validation of the test is well underway and is expected to be completed by the end of 2021. As with many projects in biotech worldwide, the COVID-19 resurgence over the last month has impacted the final stages of validation by constraining people, resources and timelines. The Company has therefore taken the decision to launch EpiSwitch® CiRT in the new year, but is preselling the test to selected oncologists now and is poised to officially launch with an accompanying marketing campaign early in 2022.

The Company expects to make further announcements related to EpiSwitch® CiRT in the coming weeks.

The EpiSwitch® assay technology used in the development of EpiSwitch® CST and EpiSwitch® CiRT is well-established. OBD's 3D genomics platform has been leveraged by leading pharma and clinical research teams for practical patient stratification in prognostic, predictive and early diagnostic applications across immuno-oncology, autoimmune and neurodegenerative indications [1-3].

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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.

In 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. Its next product will be EpiSwitch® CiRT (Checkpoint Inhibitor Response Test), a predictive immune response profile for immune checkpoint inhibitor treatments, to be officially launched in early 2022. 

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 team in the US 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.

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.

Oxford BioDynamics is leveraging its leading technology to develop a pipeline of tests in a wide range of indications, such as immuno-oncology, oncology, and veterinary medicine, to follow the release of its EpiSwitch® CST (Covid Severity Test).

A copy of this announcement is available on the Company's website at www.oxfordbiodynamics.com.

References

1. Carini C, Hunter E, et al. Chromosome conformation signatures define predictive markers of inadequate response to methotrexate in early rheumatoid arthritis. J Transl Med. 2018.

2. Hunter E, McCord R, et al. Comparative molecular cell-of-origin classification of diffuse large B-cell lymphoma based on liquid and tissue biopsies. Transl Med Commun. 2020;5.

3. Shah P, Hunter E, et al. Development and validation of baseline predictive biomarkers for response to immuno-checkpoint treatments in the context of multi-line and multi-therapy cohorts using EpiSwitch epigenetic profiling. J Immunother Cancer. 2019;7.