Oxford Biodyn Regulatory News (OBD)

Podium presentation at ESMO highlights unique benefitof OBD's EpiSwitch® platform

· Prof Thomas Powles, Director of Barts Cancer Centre, presented compelling data at ESMO'22 highlighting benefits of EpiSwitch® testing for predicting response to cancer checkpoint inhibitor therapy

· Study co-authored with Pfizer and five global medical centers

· Substantial interest in OBD's EpiSwitch Checkpoint inhibitor Response Test (CiRT) from oncologists, private insurers, as well as major pharma at the meeting

· EpiSwitch CiRT is already in clinical use in the UK and US

· Healthcare systems could achieve significant savings by avoiding or reducing administration rate of ineffective ICI treatments through personalized testing with CiRT

Oxford, UK - 15 September, 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, announces that its flagship EpiSwitch clinical platform was highlighted in a high-profile late-breaking podium presentation at the European Society of Medical Oncology (ESMO) Congress 2022, in Paris, France.

In the presentation, co-authored with Pfizer, renowned oncology expert Prof Thomas Powles (Director, Barts Cancer Centre) highlighted the benefits to clinical practice of including EpiSwitch blood testing when predicting treatment response to avelumab, a leading immune checkpoint inhibitor (ICI).

"We looked at EpiSwitch markers in the blood of almost 500 patients from the JAVELIN 100 clinical study. Exploratory work with EpiSwitch testing could pick out patients who would respond to checkpoint inhibitors that conventional tumor mutational burden [TMB] testing did not identify," said Professor Powles. "What is exciting is that the EpiSwitch platform enables us to do this from blood, rather than traditional methods which require an invasive tissue biopsy from the tumor."

Pfizer's  JAVELIN 100 trial was a multicenter, multinational, randomized, open-label, parallel-arm clinical trial that examined avelumab plus the best supportive care (BSC) versus BSC alone in patients with advanced urothelial cancer (UC) that had not progressed with first-line chemotherapy. 700 patients with unresectable locally advanced or metastatic UC without disease progression with 4-6 cycles of first-line gemcitabine plus cisplatin or carboplatin were randomized in a 1:1 ratio to receive avelumab.

The ESMO session's co-chair, Dr Rana McKay (UC San Diego Health), later reiterated the findings that the EpiSwitch platform successfully captures key host factors in the blood that are associated with better or worse outcomes, which tissue-based methods cannot see. The work was authored with collaborators from Pfizer and five global medical centers: Dana-Farber Cancer Institute (MA, US), Barts Cancer Institute (UK), Fred Hutchinson Cancer Center (WA, USA), Princess Margaret Cancer Center (Canada) and Meyer Cancer Center (NY, USA).

There was substantial interest in EpiSwitch CiRT during the ESMO meeting. Clinical oncologists, private insurers, decision-makers within healthcare systems, and major pharma visiting OBD's booth engaged enthusiastically with the OBD team, building on the momentum generated at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022.

"Similar to our experience at ASCO, we were again overwhelmed by the interest in EpiSwitch CiRT," said Thomas Guiel, OBD's Chief Operating Officer. "The work presented by Prof. Powles and Dr. McKay highlighted the power of EpiSwitch to correctly predict a person's likelihood of response to checkpoint inhibitors, simply by analyzing a blood sample from patients enrolled in a multi-arm clinical trial. We are delighted to support doctors and their patients with a test they can rely on when making important clinical decisions, and assist the healthcare industry and payors in managing costs better."

OBD's EpiSwitch CiRT is a first-of-its-kind precision medicine test that predicts a cancer patient's likely response to Immune Checkpoint Inhibitors (ICIs), including anti-PD-L1 and anti-PD-1 therapies. Despite their potential benefit, it is estimated that 70%+ of patients treated with an ICI will not have a clinical response.

Launched in February 2022, the CiRT blood test has demonstrated best-in-class performance in the prediction of cancer patient response to ICIs, with high sensitivity (93%), specificity (82%), and accuracy (85%) across several ICIs from multiple pharmaceutical companies, in 15 key oncological indications. CiRT is available for immediate clinical utilization both in the UK and the US at myCiRT.com.

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 personalized testing. Savings for the US healthcare system could amount to more than $10bn.

The ESMO Congress is one of the world's largest oncology conferences, second only to the ASCO Annual Meeting, which OBD attended earlier in 2022. ESMO is the leading professional organization for medical oncology in Europe with 25,000+ members worldwide. In 2021, more than 32,700 people attended ESMO from over 155 countries, with 45% of participants being providers from the US.

For further information about the podium presentation (LBA74), read the abstract here, and summarizing news coverage here.

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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.

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.