Oxford Biodyn Regulatory News (OBD)

3 May 2019

Oxford BioDynamics Plc

("OBD" or the "Company" and, together with its subsidiaries, the "Group")

oxford biodynamics JOINS ALS BIOMARKER STUDY Sponsored by mitsubishi tanabe pharma america

Proprietary Technology Platform to Assess Biomarker Panels in People with ALS

Oxford BioDynamics Plc (AIM: OBD), a biotechnology company focused on the discovery and development of epigenetic biomarkers based on regulatory genome architecture, for use within the pharmaceutical and biotechnology industry, is pleased to note today's announcement by Mitsubishi Tanabe Pharma America, Inc. (MTPA) that Oxford BioDynamics has joined the REFINE-ALS study, which was designed to identify and measure specific biomarkers in people with amyotrophic lateral sclerosis (ALS). Using an innovative technology platform to evaluate epigenetic and protein biomarkers, the company's analyses may offer insights on disease progression and treatment effect.

REFINE-ALS is sponsored by MTPA and led by Massachusetts General Hospital (MGH) Neurological Clinical Research Institute (NCRI). Biomarkers including oxidative stress, inflammation, neuronal injury/death and muscle injury, as well as clinical assessments, will be obtained from up to 300 patients in the U.S. prior to initiating treatment with edaravone, at start of treatment and at pre-specified time points for 24 weeks.

Oxford BioDynamics will evaluate biomarker panels utilizing EpiSwitchTM. This proprietary technology platform assesses a novel class of epigenetic biomarkers known as chromosome conformation signatures, which are aimed at understanding the rate of disease progression.

At least 30 genes are believed to play a role in ALS, but more information is needed on their potential impact in ALS. This, combined with the lack of reliable laboratory tests to identify ALS, contributes to poor disease diagnosis, which may impact treatment.1

All participants in the prospective, observational, longitudinal, multicenter trial will be U.S. patients prescribed edaravone, commercially available in the U.S. since August 2017. Patient biomarker data and disease progression assessments will be compared to samples stored at biorepositories and progression models, respectively. The study is expected to begin in late spring of 2019, with early interim analyses planned for later in the year.

Alexandre Akoulitchev, Chief Scientific Officer, Oxford BioDynamics said: 

"ALS is a challenging disease and we're excited to apply the EpiSwitch technology to uncover more information about its progression. We are very pleased that OBD has been selected for this pivotal prospective trial led by the world leaders in ALS therapeutic development and patient care. As an extension of our previous work in ALS based on collaborations with ALS experts, this is an acknowledgment of the utility and value that EpiSwitch offers. We look forward to collaborating with our study partners to help disease understanding and clinical care for the entire ALS community."

Stephen Apple, M.D., Senior Director of Medical Affairs, MTPA said:

"ALS is a complex disease and the specific causes of disease onset and progression are not fully understood. Through this biomarker study we are seeking to enhance our understanding of edaravone therapy in ALS. We are proud to announce Oxford BioDynamics has joined us in this effort and we look forward to seeing the data we gain from their technologies."

-ENDS-

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About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) ("Oxford BioDynamics") is a biotechnology company focused on the discovery and development of epigenetic biomarkers for use within the pharmaceutical and biotechnology industry. 

The Company's award-winning, proprietary technology platform, EpiSwitch™, aims to accelerate the drug discovery and development process, improve the success rate of therapeutic product development and take advantage of the increasing importance of personalised medicine. 

In particular, EpiSwitch™ can reduce time to market, failure rates and the costs at every stage of drug discovery. Additionally, the technology provides significant insights into disease mechanisms for drug discovery and product re‐positioning programmes, and enables the personalisation of therapeutics for patients in the context of challenging pricing environments where improved clinical outcomes are critical.

In April 2019, Oxford BioDynamics received the Queen's Award for Enterprise: Innovation. The Queen's Awards for Enterprise are the most prestigious awards for UK businesses.

The Company is headquartered in the UK and listed on the London Stock Exchange's AIM under the ticker "OBD". For more information please visit www.oxfordbiodynamics.com.

About Mitsubishi Tanabe Pharma America, Inc.

Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation's (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. MTPA is dedicated to delivering innovative products that address the unmet medical needs of patients in North America. It was established by MTPC to commercialize approved pharmaceutical products in North America with plans to expand its product line through collaborations with partners. For more information, please visit www.mt-pharma-america.com.

Overview of Mitsubishi Tanabe Pharma Corporation (MTPC)

Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan's pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company and has the longest history of any listed company in Japan.2 In accordance with the corporate philosophy of "contributing to the healthier lives of people around the world through the creation of pharmaceuticals," the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 2016-2020. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas - autoimmune diseases, diabetes and kidney diseases, central nervous system diseases, and vaccines - Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA and the license holder of edaravone. For more information, go to http://www.mt-pharma.co.jp/.

1 Mathis S, Goizet C, Soulages A, et al. (2019) Genetics of amyotrophic lateral sclerosis: A review. J Neurol Sci, 399, 217-226.

2 Research by TOKYO SHOKO RESEARCH, LTD