Oxford BioDynamics announces US launch of its

 Checkpoint Inhibitor Response Test (EpiSwitch® CiRT) for oncology

·   First-of-its-kind precision medicine test to predict a cancer patient's response to an Immune Checkpoint Inhibitor (ICI)

·   Provides guidance to support critical treatment decisions on beginning or continuing treatment with this essential class of cancer therapeutic

·   A significant advancement in harmonizing the prediction of response to ICI treatment, as demanded by the FDA and oncologists

·   Clinically validated blood test now available to oncologists across the US; early adopter orders from oncologists are being booked

·   EpiSwitch CiRT delivers best in class performance: 93% sensitivity, 82% specificity, 85% accuracy

Oxford, UK - 25 February 2022 - Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for immune health based on its EpiSwitch 3D genomics platform, has announced the successful clinical validation and US launch of its Checkpoint Inhibitor Response Test (EpiSwitch® CiRT).

The first-of-its-kind clinical blood test predicts the likelihood of a cancer patient's response to an essential, widely used class of therapeutics - Immune Checkpoint Inhibitors (ICIs) - including anti-PD-L1 and anti-PD-1 immunotherapies.  The robust EpiSwitch qPCR blood test has demonstrated best-in-class performance, with high sensitivity (93%), specificity (82%), and accuracy (85%) [1] across several ICI's from multiple pharmaceutical companies and more than 15 key oncological indications.

Every cancer patient travels a unique path from diagnosis to treatment that requires making complex decisions with their doctor. Many patients are considered for ICI immunotherapy - an alternative approach to chemotherapy or radiation - that works with a patient's immune system to fight cancer. ICIs have been the paramount breakthrough in cancer treatment and are now used against more than 15 types of cancer [2]. However, typically less than 1 in 3 patients receiving ICIs shows any benefit; instead, many experience serious toxicity events affecting almost any organ [3] as well as facing significant financial burden to pay for these specialised biologic medicines.

Rapid expansion of the checkpoint inhibitor class (with 8 currently approved and many more in the review pipeline) has led to appeals by the FDA and leading oncologists for harmonization and coordination of the latest ICI developments [4]. Robust and universal prediction of response to ICI treatment is seen as one of the key tools for harmonization: assisting physicians in their decisions on choices of treatment, protecting patients, leading to greater efficiency in drug development, reducing costs and protecting valuable resources [4].

OBD's EpiSwitch CiRT enables doctors to make an informed decision on whether to recommend beginning or continuing treatment with an ICI. Using a routine blood test rather than an invasive biopsy, CiRT offers fast, personalized guidance. OBD has partnered with NEXT Molecular Analytics (VA, USA) to clinically validate EpiSwitch CiRT within its high complexity CLIA-certified laboratory.  Delivering the CiRT as an LDT is consistent with OBD and NEXT's aim of getting these important tests into the hands of physicians to meet demand and help patients as quickly as possible.

In the past several months OBD's market access team has engaged significantly with the early adopter community to inform oncologists about the CiRT test, obtain voice of customer feedback and prepare for the first use of the test upon launch. The response from oncologists who have engaged with Oxford Biodynamics has been encouraging and initial orders are being booked.

Dr Jon Burrows, CEO of Oxford BioDynamics, said:
"Oxford Biodynamics Checkpoint Inhibitor Response Test (EpiSwitch® CiRT) is a very important step forward for precision medicine. EpiSwitch® CiRT directly links clinical outcome to gene regulation and with high accuracy predicts patient response. Since one in two of us will be diagnosed with cancer in our lifetime, it is essential to develop smart testing that can rapidly predict treatment response and guide us to the most efficacious therapies and maximize benefits for patients.

"In terms of the healthcare economics, ICIs alone cost the US healthcare system $17B annually.  The ability to stratify patients based on their likelihood of response will enable the system to better manage these costs while allowing us to deliver smarter, better care to patients."

Tom Reynolds, President of NEXT Molecular Analytics said:

"We are excited to be working with Oxford BioDynamics to bring this novel and sensitive Checkpoint Inhibitor Response test to oncologists and their patients in the US market. The EpiSwitch CiRT will provide oncologists with a powerful new tool to help manage complex treatment decisions with their patients."

EpiSwitch CiRT was built using OBD's well-established EpiSwitch 3D genomics platform, used to discover the most important drivers that determine a patient's response to ICIs. For each patient, CiRT captures a personal fingerprint of their complex cancer genomic and immune system interactions. The EpiSwitch 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 [5-7].

The US launch of CiRT follows the earlier launch of EpiSwitch CST (COVID Severity Test) and expands OBD's immune health test offerings.

Further information about the EpiSwitch® CiRT is available at: www.myCiRT.com.

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For more information:

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.

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.

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

References

1.   Hunter, E., Desfouli, M. 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.   Martins, F., Sofiya, L. et al. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol 16, 563-580 (2019). https://doi.org/10.1038/s41571-019-0218-0

4.   Beaver, J.A., Pazdur, R. The wild west of checkpoint inhibitor development. New England J Med  (2021) Dec 15. doi: 10.1056/NEJMp2116863. Epub ahead of print. PMID: 34910860.

5.   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.

6.   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.

7.   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.