Oxford BioDynamics plc (LON:OBD), a biotechnology company focused on the discovery and development of epigenetic biomarkers, based on regulatory 3D genome architecture, using its liquid biopsy platform EpiSwitch™, has announced its interim results for the six month period to 31 March 2020.
CORPORATE AND OPERATIONAL HIGHLIGHTS
· Board restructuring to support future growth worldwide, with a special focus on the US, with the appointment of Dr Jon Burrows as Global Chief Executive Officer (March 2020)
· Presentation of significant results of the utility of OBD’s EpiSwitch™ in predicting response to immuno-oncology (IO) treatments, co-authored with Pfizer, EMD Serono and Mayo Clinic, offering significant commercial potential (November 2019)
· Signature of master services agreement with top US pharmaceutical company (December 2019)
· Publication in peer-reviewed Translational Medicine (Communications) of the development of the first successful blood-based assay for prognostic stratification and disease subtyping in diffuse large B-cell lymphoma (DLBCL), in collaboration with Roche and Genentech (March 2020)
· Recruitment of first patient to the Mitsubishi Tanabe Pharma America (MTPA)-sponsored REFINE-ALS clinical study, in which EpiSwitch™ biomarkers are used to assess the rate of amyotrophic lateral sclerosis (ALS) disease progression (October 2019)
· Appointment of Professor Iain McInnes to the Company’s Scientific Advisory Board (October 2019)
· Revenue of £0.2m (H1 2019: £0.6m)
· Operating loss of £2.4m (H1 2019: £1.7m)
· Cash and term deposits of £13.9m as at 31 March 2020 (31 March 2019: £16.9m, 30 September 2019: £15.5m)
· Inclusion of the Group’s EpiSwitch™ technology in the GETAFIX clinical study, in collaboration with University of Glasgow, to perform prognostic and predictive profiling of COVID-19 patients (April 2020)
· Receipt of first 500 samples under master services agreement with top US pharmaceutical company announced in December 2019 (April 2020)
· Appointment of the Group’s Chief Scientific Officer, Dr Alexandre Akoulitchev, to represent OBD on the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Steering Committees in Oncology, Inflammation & Immunity, and Neuroscience in Bethesda, MD, USA (April 2020)
· Appointment of industry expert Dr Peter Pack as Independent Non-Executive Chairman, succeeding Stephen Diggle (June 2020)
Commenting on the results, Jon Burrows, Chief Executive Officer of Oxford BioDynamics, said:
“By reducing to practice and presenting the utility of our IO non-response EpiSwitch™ classifier at SITC in November 2019 followed by the commercially validating execution of an MSA with one of the industry’s leading pharma companies in December 2019 to use the EpiSwitch™ platform for biomarker development, it is clear that OBD is beginning to put itself firmly on the map as an innovative value adding technology company to partner with for pharma drug development and precision medicine.
The completion and publication of our work in DLBCL with Roche and Genentech and our participation in the REFINE-ALS clinical trial with Mitsubishi Tanabe Pharma America are further evidence of our early reach into the commercial space.
Finally, the turn in a commercially dedicated direction has been completed by the appointments of a commercially seasoned Global CEO and Chairman to lead the Company through the effects of COVID-19 and into the commercial opportunities of 2021. We look forward to updating the market on our future progress.”
CHIEF EXECUTIVE OFFICER’S REVIEW
During the six-month period to 31 March 2020, OBD continued to make significant commercial, organizational and scientific progress. The period also saw the introduction of COVID-19-related restrictions in the Group’s key locations and markets: as well as contributing to the research-driven fight against coronavirus, OBD’s strengthened leadership team is focused on planning to emerge from current restrictions with renewed commercial focus.
New leadership with extensive industry experience and US commercial focus
I joined the Group as Chief Executive Officer at the end of the period, on 23 March 2020 and nearly three months of my tenure have been spent in the COVID-19 lockdown. This extraordinary situation has severely curtailed the Company’s business development continuity, but it has afforded me a valuable opportunity to spend time getting to know the rest of the OBD executive team, reviewing the Group’s current position and reshaping the commercial mindset of the team. I am pleased to report my overwhelmingly positive experience of the OBD team that I am leading, of the Group’s EpiSwitch™ technology and the remarkable depth of R&D, data and know-how possessed by the Company. In my deep dive into OBD’s niche platform technology and capabilities I see significant commercial potential, particularly in the EpiSwitch™ classifiers that have been developed to predict likely response to IO therapies, our prognostic and disease subtyping assay for DLBCL, which outperformed a number of industry standard tests, our rapidly developing work on disease severity in COVID-19 and in the bioinformatics foundation that supports the contextual interpretation of OBD’s data.
As we plan for the gradual ending of lockdown in the US and UK, I am very positive about the Group’s prospects. I intend to bring a refreshed mindset and unrelentingly commercial focus to all of our activities. To that end, we are planning for a number of appointments to critical positions, predominantly in the US (in human resources, customer service, product development, marketing and bioinformatics) as soon as we are able.
Post-period end on 3 June 2020, the Board elected industry expert Dr Peter Pack to the position of Independent Non-Executive Chairman. Peter joined the OBD Board in April 2019 and in his first year as a Non-Executive Director has provided excellent support and challenge to the Executive Directors, as well as developing a deep understanding of OBD’s technology and business. Peter’s extensive industry experience, much of it gained in the fields of diagnostics and biomarkers, make him particularly well-suited to helping guide the OBD Board through the next stages of the Group’s journey.
Peter and I are already working well together, and I look forward to him leading the Board as we move toward fuller realization of the commercial potential of the EpiSwitch™ technology platform. The Board also thanks Stephen Diggle for his commitment and leadership in the role of Interim Chairman since April 2019. Steve has returned to his role as Non-Executive Director.
Earlier, in October 2019, the Company was pleased to appoint Professor Iain McInnes CBE to its Scientific Advisory Board. Iain is currently the Director of the Institute of Infection, Immunity, and Inflammation, Muirhead Professor of Medicine and Professor of Rheumatology at the University of Glasgow. OBD has collaborated with Professor McInnes and his teams on several successful research projects since 2014, and immediately following my appointment we jumped right into the Group’s recently announced participation in the GETAFIX COVID-19-related clinical study, with the University of Glasgow which is outlined below.
Response to COVID-19 pandemic
Shortly after the period end, in April 2020, the Company announced the selection of its EpiSwitch™ platform for prognostic and predictive profiling of COVID-19 patients in the GETAFIX clinical study, in collaboration with the University of Glasgow. As well as seeking a biomarker profile to predict likely response to the anti-viral treatment Favipiravir, OBD plans to develop a predictive disease severity classifier, to help identify patients who may be at increased risk of serious illness or death as a result of overreaction of their immune systems in so-called “cytokine storms”. These occur when the response of the body goes into overdrive triggering excessive release of key regulators of inflammation – cytokines, leading to tissue damage by the patient’s own immune system. Cytokine storms are well-known complications in a number of diseases such as flu, SARS, or sepsis and similar reactions are observed in patients with multiple sclerosis, pancreatitis, or as a common side effect of IO treatments such as CAR-Ts and TCRs. We believe such a classifier could therefore have broad clinical utility and significant commercial potential.
In addition to its involvement in the research-driven fight against COVID-19, the Group set out its operational response to the current pandemic in our business update on 21 May 2020. We restate here that the COVID-19 pandemic has already had an impact, which is expected to continue, on the timing of certain existing projects, directly as a result of delays in receipt of blood samples, especially from cohorts of patients who are considered particularly vulnerable to serious illness from a COVID-19 infection. In addition, travel restrictions worldwide have impacted business development activity. The likely severity and duration of the pandemic and its impact on OBD’s customers’ activities remains uncertain.
Notwithstanding these issues, the Group is in a strong position to navigate the current crisis, with cash and fixed-term deposits at 31 March 2020 of £13.9m, sufficient to fund planned activity for several years. To date, none of the Company’s UK employees has been put on furlough. Activity has continued on several projects including the receipt, in April 2020, of the first 500 patient samples to be analysed under the master services agreement announced on 20 December 2019 (referred to below). The Company continues to do everything possible to keep its employees safe. Our most recent risk assessments have allowed us cautiously to increase the number of laboratory personnel permitted to work at our facilities, while still following strict social distancing rules.
Commercial and scientific progress
In October 2019 the first patient was enrolled in the Mitsubishi Tanabe Pharma America-sponsored REFINE-ALS clinical study, in which the Group’s EpiSwitch™ technology platform is to be used to assess the rate of ALS disease progression using highly novel epigenetic biomarkers. Recruitment to this study has been affected by the COVID-19 pandemic and we have not yet received patient samples for laboratory analysis.
In November 2019, the Company’s EpiSwitch™ technology featured in two poster presentations at The Society for Immunotherapy of Cancer’s 34th Annual Meeting. The presentations, co-authored with collaborating scientists from EMD Serono, Pfizer, Oxford BioDynamics and the Mayo Clinic, showed that biomarkers identified by EpiSwitch™ using blood samples from patients treated with immune checkpoint inhibitors enabled robust exclusion of non-responders across cancer indications and therapeutic combinations, provided asset-specific classifiers with high positive predictive value, and had the potential to enable IO drug development programmes to advance with smaller patient cohorts. As we noted at the time, the ability to stratify patients based on their genomic architecture to reduce the risk, cost and time-to-market for therapeutic development programmes would be a game changer in IO.
In December 2019, the Group entered into a master service agreement for the development of predictive EpiSwitch™ biomarkers with a top US pharmaceutical company. This agreement built on OBD’s proven ability to develop predictive biomarkers for response in IO, granting the customer access to OBD’s unique EpiSwitch™ technology for use in the development of predictive biomarkers. The first 500 patient samples to be analysed under the agreement were received shortly after the period end in April 2020 and laboratory work has been progressing as planned.
In January 2020, further evidence of the applicability of EpiSwitch™-derived biomarkers across species was presented at American Association for Cancer Research (AACR) Conference on Advances in Liquid Biopsies, in Miami, Florida. In work conducted in collaboration with the University of Minnesota Department of Veterinary Clinical Sciences, Animal Cancer Care and Research Program, College of Veterinary Medicine and Masonic Cancer Center, OBD utilised its proprietary datasets of markers specific for regulatory 3D genome architecture associated with lymphoma in humans, as determined by EpiSwitch™. The Company’s scientists were able to translate the markers from humans into dogs, to generate a new biomarker signature using whole blood from a cohort of dogs with lymphoma and validate it on a second cohort. The results of this study indicate that EpiSwitch™ biomarkers can be successfully translated across species for related pathologies and conditions and highlight the potential application of non-invasive EpiSwitch™ biomarkers in new therapeutic developments, including in the veterinary industry.
In March 2020, the results of OBD’s work in collaboration with Roche and Genentech to develop a blood-based EpiSwitchTM signature for non-invasive prognostic stratification of Diffuse large B-cell lymphoma (DLBCL) patients were published in the peer-reviewed journal Translational Medicine (Communications). DLBCL is the second most common type of blood cancer after Hodgkin’s Lymphoma. Within this disease there are two distinct subtypes associated with cell of origin: germinal centre B-cell-like (GCB) and activated B-cell-like (ABC). Conventional methods for identifying disease subtypes use complex and time-consuming gene expression-based platforms that require an invasive biopsy to obtain a diagnosis and often fail to assign the correct subtype. The two subtypes follow different disease courses and respond differently to therapeutic intervention, with the ABC subtype having a far worse survival prognosis; it is therefore important to determine a patient’s subtype as early as possible. Importantly, a significant group of patients do not manifest clear ABC or GCB transcriptional profiles and are classified as Type III (Unclassified), despite showing underlying differences in prognostic outcomes. OBD’s EpiSwitch™ platform was used in a full programme of biomarker development, beginning with screening and biomarker evaluation in 60 patients with a known subtype, followed by validation of that EpiSwitchTM prognostic classifier on an independent cohort of 58 Type III patients, comparing the prognostic call made with EpiSwitch™ with the clinical outcome of patient survival. The results of the study were striking, showing that the EpiSwitch™ DLBCL biomarker signature was accurate in classifying confirmed ABC and GCB subtypes in patient samples of known status, providing an identical call in all 60 samples. Furthermore, the EpiSwitch™ biomarker signature was able to classify all 58 Type III samples into subtypes, correctly predicting clinical outcome with a high level of statistical significance and outperforming a number of current industry standard gene expression-based assays. The prognostic calls on patients prior to their treatment made using the EpiSwitch™ classifier had significant correlation with actual survival rates, demonstrating the potentially transformative utility of an EpiSwitch™ assay in the clinical management of DLBCL.
Shortly after the period end, in April 2020, the Group’s Chief Scientific Officer, Dr Alexandre (Sasha) Akoulitchev, was appointed to represent OBD on three Steering Committees of the FNIH Biomarkers Consortium, in Oncology, Inflammation & Immunity, and Neuroscience, in Bethesda, MD, USA. The Biomarkers Consortium is a public-private biomedical research partnership managed by the FNIH that endeavours to discover, develop, and seek regulatory approval for biomarkers, to support new drug development, preventive medicine, and medical diagnostics. The members of the Steering Committees represent a variety of sectors, including academia, government, industry and not-for-profit/advocacy organisations and are responsible for identifying and moving forward promising biomarker projects for implementation by the Consortium. Sasha’s appointment to the Steering Committees represents both a major recognition of his expertise in the field and an opportunity to share the application of OBD’s EpiSwitch™ platform in a highly respected scientific forum.
IP portfolio development
OBD’s IP portfolio now includes fourteen patent families, with the latest application having been filed after the period end in early June 2020. During the period, the Group continued its strategy of seeking to obtain claims which provide the best possible protection for its EpiSwitch™ platform and the biomarkers that are derived from it; two patents were granted, a further one entered the national phase and supplementary information was submitted to patent offices in connection with one other. The Group also benefits from significant technological and scientific know-how within its team and valuable proprietary experimental data.
The period to 31 March 2020 saw the Group continue to make commercial and scientific progress on several fronts whilst initiating a transition to newly appointed, commercially focused executive leadership. The period saw the beginning of COVID-19-related restrictions, with the Group in a strong position not only to survive the period without external financial assistance, but also to apply its EpiSwitch™ technology to research into the effects of the virus.
In the remainder of the year, we expect to emerge from the immediate effects of the pandemic with renewed organizational focus, building on the Group’s progress to date for significant growth in 2021 and beyond. We look forward to providing shareholders with news of further positive developments in due course.
Dr Jon Burrows
Chief Executive Officer
Oxford BioDynamics plc 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 personalization 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.