Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics signs supply and resale agreement with Agilent Technologies,and launches EpiSwitch® Explorer Array Kit for R&D use

· Agilent Technologies to manufacture custom microarray based on OBD's proprietary probe sets for EpiSwitch® Explorer Array Kit

· First commercial microarray kit available for high-resolution 3D genome profiling and biomarker discovery

· Kit accompanied by EpiSwitch® Data Portal to enable powerful, intuitive analytics of research data and access to 3D genome knowledgebase

· Launch of the EpiSwitch® Explorer Array Kit expands academic and clinical researcher access to OBD's EpiSwitch® technology platform following the launch of its EpiSwitch®CST (COVID-19 Severity Test)

Oxford, UK - 31 March 2021- Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for personalized healthcare based on the EpiSwitch® 3D genomics platform, and Agilent Technologies (NYSE: A), a global leader in the life sciences, diagnostics, and applied chemical markets, have signed a supply and resale agreement for the manufacture and sale of the new EpiSwitch® Explorer Array Kit ("Kit").

Under the terms of the agreement, Agilent will supply a custom-made SurePrint G3 CGH Microarray for the Kit, incorporating OBD's proprietary 3D genome probes. OBD has exclusive rights for supply and distribution of the Kit.

Harnessing the strengths of Agilent's microarray technology and OBD's 3D genomic recognition algorithms, the EpiSwitch® Explorer Array Kit provides results at a high throughput, with high resolution in a fraction of the time. The Kit simultaneously interrogates almost 1 million 3D genomic sites, providing over ten times more high-value data points than conventional, costly, time-consuming methods of detection, which are limited by high noise to signal ratio. This creates a highly reproducible, unbiased map, which can be used to identify, evaluate, or monitor 3D genomic biomarkers.

The newly launched Kit, which is for research use only, will enable a new level of whole genome screening, biomarker discovery, and profiling of the 3D genome. It can assist researchers by analyzing the genome's 3D architecture and the crucial role it plays in gene regulation.

Improved understanding of the 3D genome could have a significant impact on patient diagnosis, prognosis of disease response, and determination of treatment options. The global epigenetics market size is expected to reach over $22 billion by 2025, with the kits segment anticipated to experience the greatest growth (>20% CAGR), driven by this need for biomarker development and accurate detection for personalized medicine [2].

The EpiSwitch® platform has already been used to develop the recently launched COVID-19 Severity Test, EpiSwitch® CST. Further tests are being developed in other areas including immuno-oncology response, rheumatoid arthritis and prostate cancer [3-8].

Dr Jon Burrows, CEO of Oxford BioDynamics, said:"EpiSwitch® is already well validated in pharma biomarker discovery and has proven capable of stratifying patients for many biological indications [3-8]. OBD has previously announced the expansion of its strategic focus [1] to bring the platform to the precision medicine market, starting with the launch of our COVID-19 Severity Test and the upcoming launch of an IO test. Alongside this strategy, we are keen that our technology and knowledgebase are made available for research and development by academic and clinical researchers worldwide."

He added: "Partnering with industry leader, Agilent, gives important third-party validation to our technology and working together will strengthen the commercial offering of our EpiSwitch® Explorer Array Kit to the global research community."

Kevin Meldrum, VP/GM of Agilent Genomics said: "Agilent is the premier provider of custom microarrays and we are excited to secure this partnership with Oxford BioDynamics demonstrating how arrays can enable the development of new technologies, such as EpiSwitch®, beyond gene expression and CGH."

To accompany the Explorer Array Kit, OBD will also provide access to their online EpiSwitch® Portal to enable array data analytics and provide biological context for readouts. This Portal comprises of two applications:

1. The EpiSwitch® Analytical Portal (EAP) - to enable statistical analysis of 3D-array data with a wide range of tools

2. The EpiSwitch® Data Portal (EDP) - to provide options to map data to the genome, allowing integration of analysis with other data types (SNPs, Hi-C, ATAC-Seq Chip-Seq, RNA-Seq, etc.) and biological interpretation

The EpiSwitch® Explorer Array Kit is now available to purchase from OBD's online store: https://store.oxfordbiodynamics.com. Here, users can also sign up and access the EpiSwitch suite of analytical portals. The Kit is provided with EpiSwitch®-optimized sample preparation reagents for analysis of blood, PBMC and primary cell or cell line samples.

-Ends-

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.

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. The Company recently released its first commercial prognostic test, EpiSwitch® CST (Covid Severity Test).

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, neurodegenerative and autoimmune diseases, to follow the release of its EpiSwitch® CST (Covid Severity Test). 

References

1 - Oxford BioDynamics Plc. (2020). Oxford BioDynamics to expand strategic focus [Press release]. 15 Dec 2020. Available at: www.londonstockexchange.com/news-article/OBD/oxford-biodynamics-to-expand-strategic-focus/14792751

2 - ResearchAndMarkets. The Global Market for Epigenetics to 2025: Size, Share & Trends Analysis by Technology, Application and Product. Accessed Mar 2021. Available at: https://bwnews.pr/3fv9zp0

3 - Hunter, E., Koutsothanasi, C., et al. (2021). 3D genomic capture of regulatory immuno-genetic profiles in COVID-19 patients for prognosis of severe COVID disease outcome. BioRxiv, 2021.03.14.435295. https://doi.org/10.1101/2021.03.14.435295 (prognosis of severe COVID outcomes)

4 - Hunter, E., Potluri, S., et al. (2019). Development and validation of baseline predictive biomarkers  for response to avelumab in second-line (2L) non-small cell lung cancer (NSCLC) using EpiSwitch  (TM) epigenetic profiling. SITC, J. Immunotherapy Cancer 7(282) P142. www.oxfordbiodynamics.com/wp-content/uploads/2020/06/SITC2019_P142_avelumab.pdf (IO for Avelumab with Pfizer & EMD Serono)

5 - Hunter, E., Potluri, S., et al. (2019). 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 (TM) epigenetic profiling. SITC, J. Immunotherapy Cancer 7(282) P143. www.oxfordbiodynamics.com/wp-content/uploads/2020/06/SITC2019_P143_multitherapy.pdf (IO for Multitherapy cohorts with Lyell Immunopharma, Mayo Clinic, Pfizer & EMD Serono)

6 - Hunter, E., McCord, R., et al. (2020). Comparative molecular cell-of-origin classification of diffuse large B-cell lymphoma based on liquid and tissue biopsies. Translational Medicine Communications, 5(1). https://doi.org/10.1186/s41231-020-00054-1 (prognostic for B cell lymphoma)

7 - Carini, C., Hunter, E., et al. (2018). Chromosome conformation signatures define predictive markers of inadequate response to methotrexate in early rheumatoid arthritis. J Trans. Med, 16(18). https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1387-9 (predictive for inadequate response to MTX in rheumatoid arthritis)

8 - Alshaker, H., Mills, R., et al. (2021). Chromatin conformation changes in peripheral blood can detect prostate cancer and stratify disease risk groups. J Transl Med 19(46). https://doi.org/10.1186/s12967-021-02710-y (prognostic for high-risk prostate cancer)