Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics plc

Oxford BioDynamics to expand strategic focus beyond biomarker discovery to development and commercialization of laboratory tests  

· EpiSwitch™ platform has been proven to stratify patients for many biological indications and is well validated in pharma biomarker discovery; it is now directly applicable to the precision medicine market

· Complementary strategy to expand technology platform into multiple commercial pathways, including laboratory tests based on EpiSwitch™ 3D genomics for near term commercialization

· First 3D genomic test to assess Covid-19 severity to be launched in Q1 2021

· Immuno-oncology (IO) test expected to follow on in 2021 based on successful stratifications detailed and publicised last year at the SITC oncology conference

· Array-Kit for R&D and EpiSwitch™ data analytics portal expected to follow on in 2021

Oxford, UK - 15 December 2020 - Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for personalized healthcare based on the EpiSwitch™ 3D genomics platform, announces the expansion of its strategic focus.

Since his appointment in March 2020, the Company's new CEO, Dr Jon Burrows, has been assessing Oxford BioDynamics' business, its EpiSwitch™ technology, and ways in which the Company can unlock its considerable growth potential and bring its technology pipeline rapidly into the precision medicine market.

Reviewing 2020, the Covid-19 crisis caused some slowdowns across the pharma/biotech industry, however, Oxford Biodynamics was able to continue working on samples delivered under a Master Services Agreement signed last December with a world leading publicly quoted pharma company, with which management continues to work closely. Also, after an initial delay due to Covid-19, the Company has now started to receive samples from Mitsubishi Tanabe Pharma, enabling it to continue working on the biomarker program for its already approved ALS drug.

By June 2020, the Company started to use its know-how and resources to develop its proprietary Covid-19 severity test which has been completed in less than six months, a great achievement for the OBD team.

Dr Jon Burrows, CEO of Oxford BioDynamics, said:

"Having worked for over two decades in molecular medicine and diagnostics, I believe that, through precision medicine, 3D genomics will play a prominent role in how personalized healthcare evolves. My decision to join Oxford BioDynamics was primarily driven by this, as well as seeing the innovation inherent in the Company's technology, EpiSwitch™, and the experience of the team behind it. Over the last several months, these qualities have very much been confirmed.

"The Company's EpiSwitch™ technology is built on 1 million data points for each patient and is closely linked to clinical outcomes. Based on these strengths, we can offer critical insights into how an individual is affected by disease, beyond the scope of other molecular testing such as next generation sequencing or traditional epigenetics. This has led to the first step in the expanded strategy, to develop a Covid-19 "severity-of-response" test."

OBD's strategy to date has been to work with big pharma on biomarker development projects, incorporating EpiSwitch™ into clinical development projects, and to capture value in third party validation of the technology through licensing, milestones, and royalty deals. This sales channel will continue as a part of OBD's expanded strategic focus. In addition, OBD now intends to offer its precision medicine testing via partner laboratories, starting with a Covid-19 severity-of-response prognostic test. The Directors believe that having multiple commercial options will enable the Company to leverage its existing technology pipeline, while recognition from commercial partners will further underpin its growth. This strategy expansion is now under way.

Using the previously demonstrated power of the EpiSwitch™ 3D genomics platform, OBD is completing the development of a Covid-19 severity of response test, built on a representative international set of Covid-19 patient cohorts from Europe, USA, and Latin America. The aim of this test is to provide crucial information to address the open medical questions regarding an individual's risk of disease severity and need for hospitalization, including intensive care unit support. The Directors believe this represents a significant opportunity for the Company to contribute to solving the immediate needs of the global population, as well as further validating the EpiSwitch™ 3D genomics platform as a practical tool for precision medicine and personalized healthcare.

The Company is also looking to continue to work on other products and indications such as rheumatoid arthritis and lymphoma (ref 1-3). The first follow-on test in the pipeline for 2021 will be a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments (ref 4,5). Some patients respond more positively than others to these medicines. The aim of the EpiSwitch™ IO response test is to help physicians stratify complete and partial responders in advance of treatment, enabling better treatment options for each individual.

In terms of other sales channels for 2021 and 2022, OBD intends to make its biomarker arrays and 3D genome bioinformatics tools available to the R&D market and to work closely with big pharma to leverage the insights of the 3D genome knowledgebase it has built.

Underpinning this strategy is a continuation of broadening and strengthening the intellectual property base behind EpiSwitch™. The Company has recently been granted another US patent: "Methods of Detecting Long Range Chromosomal Interactions" International Application.

Dr Burrows concluded:

"We believe that by working across multiple commercial channels, we can leverage the commercial potential of the EpiSwitch™ technology, to support traction and grow market adoption. Adding additional commercial pathways allows us to take control of our own future, and significantly reduces some of the timelines to market and subsequent revenue generation. The pharma industry is always looking for innovative technologies that are reduced to practice, have been proven and can answer questions that existing molecular modalities cannot. I believe EpiSwitch™ can make a significant contribution and have a substantial impact on the field of precision medicine."

-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.

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 Covid-19 severity, immuno-oncology, neurodegenerative and autoimmune diseases.

Selected References:

1. Hunter, E., McCord, R., Ramadass, A. S., Green, J., Westra, J. W., Mundt, K., & Akoulitchev, A. (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)

2. Carini, C., Hunter, E., Scottish Early Rheumatoid Arthritis Inception cohort Investigators., Ramadass, A. S., Green, J., Akoulitchev, A., McInnes, I. B., & Goodyear, C.S. (2018). Chromosome conformation signatures define predictive markers of inadequate response to methotrexate in early rheumatoid arthritis. J Trans. Med, 16(18). https://doi.org/10.1186/s12976-018-1387-19 (predictive for inadequate response to MTX in rheumatoid arthritis)

3. Grand, F. H., Salter, M., Hunter, E., & Akoulitchev, A. (2019). Ectopic Gene Deregulations and Chromosome Conformations: Integrating Novel Molecular Testing into Clinical Applications, from Leukemias to Gliomas. Handbook of Biomarkers and Precision Medicine (1st ed.), Chapman and Hall/CRC, 208-216. https://www.routledge.com/Handbook-of-Biomarkers-and-Precision-Medicine/Carini-Fidock-Gool/p/book/9781498762588 (expert chapter contribution for 3D genomics -)

4. Hunter, E., Potluri, S., Zhang, S. Dezfouli, M., Back, J., James, L., Jandor, N., Powell, R., Salter, M., Ramadass, A., Green, J., Westra, W., Dong, H., Dronca, R., Markovic, S. N., Robbins, P. B., Cai, T., Akoulitchev, A., & Shah, P. K. (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. https://www.oxfordbiodynamics.com/wp-content/uploads/2020/06/SITC2019_P142_avelumab.pdf (IO for Avelumab with Pfizer and EMD Serono)

5. Hunter, E., Potluri, S., Zhang, S. Dezfouli, M., Back, J., James, L., Jandor, N., Powell, R., Salter, M., Ramadass, A., Green, J., Westra, W., Dong, H., Dronca, R., Markovic, S. N., Robbins, P. B., Cai, T., Akoulitchev, A., & Shah, P. K. (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. https://www.oxfordbiodynamics.com/wp-content/uploads/2020/06/SITC2019_P143_multitherapy.pdf ( IO for Avelumab with Pfizer and EMD Serono)