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Oxford BioDynamics

Oxford BioDynamics Deliver on several important achievements & continued traction in IO

Oxford BioDynamics Plc (LON: 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, has today announced its final results for the year ended 30 September 2019.

Corporate and operational highlights

  • Continued development of EpiSwitch™ biomarkers for use in immuno-oncology (IO), including signing of fifth commercial collaboration.
  • Participation in amyotrophic lateral sclerosis (ALS) biomarker study sponsored by Mitsubishi Tanabe Pharma America; first patient enrolled post period end.
  • Joined trial with Imperial College London evaluating novel methods of screening for prostate cancer.
  • Collaborated with Casa Sollievo della Sofferenza to develop a panel of epigenetic biomarkers for the diagnosis of Autistic Spectrum Disorder.
  • Study identifying epigenetic changes for monitoring disease progression in Huntington’s disease published in Faculty of 1000 Research.
  • Strengthened the OBD Board and team:

o Appointed Dr David Holbrook and Dr Peter Pack as Non-Executive Directors.

o Expanded into the US by forming subsidiary and appointing Glen Ferguson to lead OBD’s business development activities in the region.

o Appointed Dr Bartu Ahiska as Senior Vice President (Commercial).

  • Awarded the prestigious Queen’s Award for Enterprise: Innovation in April 2019.
  • Expanded leading IP portfolio covering the EpiSwitch™ platform.
  • Completed expansion of UK and Malaysian R&D facilities.

Financial highlights

  • Revenue of £0.9m (FY18: £1.2m).
  • Operating loss of £3.7m (FY18: £2.6m).
  • Cash and term deposits of £15.5m as at 30 September 2019 (FY18: £18.3m).
  • Investment of US$540,000 into Holos Life Sciences.

Post-period end

  • Presentation of poster on use of EpiSwitch™ in IO, co-authored with EMD Serono, Pfizer and the Mayo Clinic.
  • Appointment of Professor Iain McInnes to OBD’s Scientific Advisory Board.

Commenting on the results, Christian Hoyer Millar, Chief Executive Officer of Oxford BioDynamics, said:

“2019 has seen OBD deliver on several important achievements. Not only have we signed additional collaboration agreements, but we have also seen EpiSwitch™ being used in high profile UK and US clinical trials. We believe there is significant potential for EpiSwitch™ biomarkers to benefit a range of diseases, but we have been particularly pleased with the progress we have announced in IO. We have continued to gain traction in this important, growing market demonstrating the value we add to the healthcare system.

We have invested significantly in strengthening our management team and Board, enhancing our presence in the US. Furthermore, the expansion of our ISO-certified R&D facilities in the UK and Malaysia has been completed, allowing us to further scale the use of our EpiSwitch™ technology.

We are well placed to take advantage of the opportunities that this growing sector is offering into 2020 and beyond, and we look forward to updating the market on our progress.”

Notice of Annual General Meeting

The Company’s Annual General Meeting will be held at The Kloppenberg Room, Cohen Quad, Exeter College, Walton Street, Oxford, OX1 2HE on 20 March 2020 at 11.00 am.

The information included in this announcement is extracted from the Annual Report, which was approved by the Directors on 9 December 2019. Defined terms used in the announcement refer to terms as defined in the Annual Report unless the context otherwise requires. This announcement should be read in conjunction with, and is not a substitute for, the full Annual Report.

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

CHIEF EXECUTIVE OFFICER’S REVIEW

Introduction

OBD made important progress during the year ended 30 September 2019, strengthening our commercial team and Board, receiving external validation of our EpiSwitch™ platform from commercial partners and other collaborators, including first-time inclusion in prospective clinical trials in the US and UK. We also completed the expansion of our ISO-certified R&D facilities in the UK and Malaysia and the integration of all aspects of EpiSwitch™ sample processing and analysis in-house.

In addition to our work with commercial partners, we have continued to focus on proprietary research in increasingly diverse high-value areas, further expanding our intellectual property (IP) portfolio.

In April 2019, we were privileged to receive the Queen’s Award for Enterprise: Innovation.

Commercial and scientific developments

Validated EpiSwitch™ biomarkers have now been developed for a wide range of diagnostic and prognostic applications, demonstrating high efficacy in stratifications in a wide range of indications. These notably performed extremely strongly against other conventional, invasive, biopsy-based methodologies. OBD’s technology offers commercial partners efficient patient profiling and disease evaluation and can help clinicians make informed decisions on preferred treatment, all based on non-invasive liquid biopsy (a small volume blood test). The potential benefits of such actionable patient stratifications are significant, as they help to implement precision medicine approaches in health care (avoiding therapies likely to fail) and to de-risk drug development for therapeutic companies (identifying the right patients for enrolment to clinical trials).

This year OBD has provided pharmaceutical and biotechnology companies with compelling evidence of the potential for EpiSwitch™ biomarkers to benefit IO drug development programmes and cancer patients, by enabling clinicians to identify patients who are unlikely to respond to IO treatment, across a wide spectrum of indications and treatment combinations, and helping to match potential responders to the right specific IO drugs.

IO represents an important, growing, competitive market, with regulatory pressure and an acknowledged need for actionable patient stratifications: some patients show highly efficacious response to IO treatment, but many current IO therapies have limited utility because of low response rates and significant subsets of patients who do not show clinically meaningful responses to treatment. OBD’s developing contribution to the field was highlighted at the beginning of this financial year in November 2018, when the Company announced its fifth commercial collaboration in IO, with a major US-based biopharmaceutical company.

In May 2019, the Company presented on “EpiSwitch™ Biomarkers: Practical Applications for Predictive, Prognostic and Diagnostic Patient Stratifications” at the China BIO Partnering Forum in Shanghai. The presentation focused on validated EpiSwitch™ biomarker applications which have demonstrated high efficacy in predictive, prognostic and diagnostic patient stratifications for lung, haematological, prostate, thyroid and skin cancers. Specifically, the results demonstrated that the baseline predictive stratifications by EpiSwitch™ for response to immuno-checkpoint inhibitors (a common type of IO therapeutic) act as excellent surrogates for standard primary endpoints used in clinical trials, such as progression free survival.

Post period end, in November 2019, OBD presented two posters co-authored with biomarker, translational and clinical teams from EMD Serono and Pfizer, and clinical experts from the Mayo Clinic at the Society for Immunotherapy of Cancer (SITC) annual meeting in National Harbor, Maryland, USA. These posters provided important external validation of the efficacy of EpiSwitch™ biomarkers in the field of IO. The OBD programme presented at SITC focused on the development and validation of predictive biomarkers and showed results from patients with non-small cell lung cancer (NSCLC) or melanoma who had been treated under common IO therapeutic regimes, using avelumab (an anti-PD-L1 antibody), pembrolizumab (an anti-PD-1 antibody), or pembrolizumab in combination with chemotherapy, and generated models to differentiate responders from non-responders.

The results showed that IO biomarkers developed with EpiSwitch™ allowed robust exclusion of non-responders across indications and combinations (identifying patients likely not to respond to any IO therapy), and provided asset-specific classifiers with high positive predictive value (identifying likely responders to a particular drug for a particular indication). The ability to enrich clinical trials by including the right patients based on their genomic architecture could reduce the risk, cost and time to market for therapeutic development programmes and could be a ‘game-changer’ in IO, enabling drug development programmes to advance with smaller patient cohorts. There is now a compelling rationale for conducting a blinded, comparator arm test to differentiate between the prognostic (likely overall outcome) and predictive (likely response to a particular drug) values of the EpiSwitch™ biomarkers identified in this work.

This year we announced OBD’s participation in the REFINE-ALS and PROSTAGRAM studies. This is the first time the Group’s EpiSwitch™ biomarkers have been included in prospective clinical trials, marking recognition by industry experts of the potential clinical utility of EpiSwitch™.

· The REFINE-ALS study is led by Massachusetts General Hospital (MGH) Neurological Clinical Research Institute (NCRI) and sponsored by Mitsubishi Tanabe Pharma America (MTPA). It is designed to identify and measure specific biomarkers to act as a complementary diagnostic for people being treated with RADICAVA® (edaravone) for ALS. OBD’s EpiSwitch™ biomarkers will be assessed alongside other biomarker modalities, as well as clinical assessments. The recruitment of the first patient (of a total of up to 300) to the trial was announced by MTPA in October 2019.

· The aim of the PROSTAGRAM trial is to assess the role of a number of diagnostic approaches, including magnetic resonance imaging (MRI), multiparametric ultrasound and OBD’s EpiSwitch™ assay to screen for prostate cancer. The EpiSwitch™ assay for prostate cancer is based on six epigenetic systemic blood-based markers and was developed in collaboration with Mr Mathias Winkler, Consultant Urological Surgeon at Charing Cross Hospital, Imperial College Healthcare NHS Trust and Professor Dmitry Pshezhetskiy, Norwich Medical School, University of East Anglia. We completed our analysis of samples from this trial in our laboratory in the second half of the financial year and await overall findings, which are expected to be reported in early 2021.

OBD has continued to focus on carrying out proprietary research in several disease areas. During the period the Group published results for the first prognostic biomarkers for progression of Huntington’s disease (F1000Research, 2018, 7:175), and biomarker stratifications with high sensitivity and predictive values for diagnosis of thyroid cancer (Surgery, Vol 165, Issue 1, in collaboration with NorthShore University HealthSystem). OBD was also invited to contribute a chapter to the “Handbook of Biomarkers and Personalized Medicine”, published in May 2019.

Since 30 September 2018, OBD has presented at a number of conferences, including the Cantor Fitzgerald Global Healthcare Conference (New York NY), 4th Annual Biomarker and Companion Diagnostics Conference (San Diego, CA), China BIO 2019 (Shanghai, China), the Nordic Life Science Days 2019 Health Tech event (Malmö, Sweden), the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting (National Harbor, MD) and 10th Malaysian Endocrine and Metabolic Society (MEMS) Annual Congress (Kuala Lumpur, Malaysia), where scientists from OBD’s reference laboratory in Malaysia presented on the successful development and validation of powerful progressive biomarkers in type 2 diabetes mellitus (T2DM), demonstrating how OBD’s EpiSwitch™ technology could assist experts in endocrinology in the management of T2DM and pre-diabetes.

As announced in December 2018, the Group exercised a pre-existing option to acquire, for a nominal amount, a 30% shareholding in Holos Life Sciences Pte Ltd (“Holos”), a company developing biomarkers to enable non-pharmaceutical enhancement of health, wellness and performance in humans and animals. OBD also participated in Holos’ interim fundraising, investing US$540,000 (£422,000) in that entity. OBD and Holos have entered into exclusive licensing agreements in both human and equine fitness, offering the Group a combination of upfront and milestone fees and sales-based royalties. In January 2018 the Company also announced a collaboration with Holos to develop non-invasive epigenetic biomarkers associated with sports-related concussions suffered by professional sportspersons, and research on this project will begin as samples become available during the coming year.

Strengthened team and Board

We significantly expanded and strengthened our commercial team with the announcement of two key appointments: Glen Ferguson, who joined in March 2019 as Senior Vice President (USA), to lead our business development activity in the world’s largest healthcare market and, in June 2019, Dr Bartu Ahiska, who joined the Company as Senior Vice President (Commercial), to spearhead the commercialisation of the Group’s EpiSwitch™ technology platform. Glen Ferguson’s background is in licensing and contract negotiation, developing strategic alliances, and expertise in the field of companion diagnostics, gained in a life sciences industry career spanning over 25 years. Dr Bartu Ahiska is a technology entrepreneur with experience in several fields including medical engineering, biologics, computing and graphics. Led by Glen, our business development team has been making excellent progress with several US-based customers and collaborators.

The OBD plc Board was joined by two new Non-Executive Directors during the year, as Dr David Holbrook and Dr Peter Pack joined us in April 2019. Both David and Peter have extensive life sciences sector experience and each of them has rapidly developed a strong understanding of the Group and its business.

Also in April 2019, Stephen Diggle (founder and Chief Executive Officer of Vulpes Investment Management, a significant investor in OBD since 2008) took on the role of Non-Executive Chairman, on the retirement from the Board of former Non-Executive Chairman, David Williams. Alison Kibble left her position as Non-Executive Director in May 2019, having served the Company since 2007. We thank both David and Alison for their commitment to OBD and wish them both every success in the future.

After the period end, in November 2019, we were pleased to announce the appointment of Professor Iain McInnes, Professor of Experimental Medicine at Glasgow University, to our Scientific Advisory Panel. Professor McInnes has a major interest in the pathogenesis of rheumatoid arthritis, psoriatic arthritis and their related co-morbidities. He leads a translational science programme in which state-of-the-art cellular and molecular biology techniques are applied to elucidate the mechanisms underlying the perpetuation of a range of chronic diseases, seeking to build precision medicine approaches and new therapeutics thereafter.

OBD has previously collaborated with Professor McInnes and members of his group in the development and assessment of EpiSwitch™ biomarkers to predict the response of patients with rheumatoid arthritis to the drug methotrexate, work which was published in the Journal of Translational Medicine in March 2018.

IP portfolio development

We have continued to develop our broad IP portfolio and now have patents filed or granted in 13 separate families, with others likely to be filed in the next few months. OBD’s extensive IP portfolio covers both our own platform technology and a wide range of indication- or application-specific cases. Over the last year, we have developed valuable IP and know-how in internal, proprietary research and development projects as well as through work with commercial partners.

Summary and outlook

It has been a year of strong progress for the Company. We have entered into multiple new research collaborations and our EpiSwitch™ platform has been used in high profile UK and US clinical trials with world leading organisations in prostate cancer and ALS.

We continue to gain recognition in the IO space and believe our EpiSwitch™ platform could have a transformational impact, by reducing the clinical development risk, cost and time to market for these important new therapeutics by enabling drug development programmes to advance with smaller more defined patient cohorts.

We have strengthened our Board and team during the period and have continued to drive the development of new and significant commercial relationships in the US market. The expanded commercial team has already begun to see positive results in our interactions with existing and new potential customers.

We expect to continue to expand our commercial and senior management team over the coming months as we seek to capitalise on opportunities to commercialise the EpiSwitch™ platform, particularly in the US.

Finally, on behalf of the Board, I would like to thank our shareholders for their support over the last year and I look forward to reporting considerable further progress in 2020.

Christian Hoyer Millar

Oxford BioDynamics Chief Executive Officer