CynapseDx has been developing products to isolate proteins or cells from whole blood since 2012.
At the heart of our techniques is an antibody coated large ultra-dense magnetic particle that can force its way through the viscous, cell-rich media of blood to encounter and bind proteins. These can be free in plasma, or cell-associated.
Our primary focus is neurodegenerative diseases, such as Parkinson’s or Alzheimer’s Disease. Previous attempts to develop blood tests for these diseases have been unsuccessful, partly due to uncertainty over which biomarkers to choose and the likely scenario that there are only very low numbers of target proteins circulating in the blood stream. We have chosen to focus on oligomeric and aggregated forms of protein biomarkers and have demonstrated that our assays can measure these forms of biomarker proteins, when testing real patient blood samples.
We have a trial underway to demonstrate this is an effective tool that can identify patients with tremor symptoms that are misdiagnosed as Parkinson’s disease when they have another brain disorder. Using treatment costs published by NICE we have estimated that in the UK, the NHS is wasting some £52 million in treatments that do not work on the numbers misdiagnosed each year.
We plan to launch test kits to the academic community in 2018 and for clinical use in 2019.
CynapseDx (originally incorporated as CellCap Technologies) initially used its dense magnetic beads to harvest intact cells from complex body tissues (blood or adipose). The technology has proved to be very useful in the capture of the oligomeric and other structural forms of biomarker proteins present in blood from patients with neurodegenerative disease, such as Alzheimer’s or Parkinson’s Diseases.
In 2014, working with Professor David Allsop’s team at Lancaster University with blood samples collected at the Salford Dementia Consortium, we tested prototype assays for the oligomeric and aggregated forms of ß-amyloid and confirmed that it is present in the blood of patients with Alzheimer’s Disease and the levels are increased compared to healthy, young (<30y) controls.
In 2015, supported with grant funding from InnovateUK, we developed an additional 2 assays for the oligomeric and aggregated forms of α-synuclein and phospho-tau and tested a wider range of patients including Parkinson’s Disease and Dementia with Lewy Bodies. The results are very encouraging and convinced our investors to back us to conduct a larger and better structured trial.
Also in 2015, we demonstrated that we can measure ß-amyloid in 0.5 ml volume of blood from a rat Alzheimer’s model, indicating that it is possible to obtain longitudinal data in animal models on the same animal, rather than on clones.
In early 2016 our investor network asked us to identify an application where use of a new diagnostic method can make a difference in current treatment programs. The concern was that uptake may be delayed in Alzheimer’s Disease because currently the drugs used are not disease modifying and so do not affect the progression of the disease (but see Latest News below).
Accordingly the NIHR Biomedical Research Unit for Lewy Body Dementia has assisted us to identify a need for better diagnosis in Parkinson’s Disease where resources are currently wasted on treatments that do not work, because patients mis-diagnosed with Parkinson’s Disease have tremors arising from a different brain condition that does not respond to current Parkinson’s medication. Clinical blood samples are currently being collected for testing by the end of 2016.
In 2016 the company changed its name to CynapseDx to better reflect the new neurodegenerative diagnostic focus.
Latest News: The recent report on Phase 1b trials on Biogen’s antibody Aducanumab showing that in some patients there was a substantial reduction in amyloid plaque in the brain and an improvement in cognitive scores is very encouraging. It supports the need for early diagnosis using blood biomarkers as once brain damage has occurred it is too late for immunotherapy.
Damian Bond (CEO, Founder) was previously S & M Director, International Diagnostics Group; Marketing Manager, Unilever; Founder & Chief Executive of Platform Diagnostics and ProKyma Technologies. He has founded three life sciences / diagnostics companies and one cleantech company. Whilst commercially focused, he is also an inventor on over 10 patent applications.
Dr Christopher Stanley (CTO, Founder) has operational experience in the in vitro diagnostics industry and the downstream bioprocessing industry; he has consulted to pharmaceutical companies on drug discovery and delivery technologies and has advised venture funds on making early stage seed investments in life sciences start-ups. He has founded four life sciences/medtech companies, taking the role of CEO or CTO. He has been a senior member of management in a molecular diagnostics company that was acquired by an EU multinational corporation, has been part of the team that acquired the assets of a UK-based plc in the rapid microbiology sector and has co-developed and licensed the leading technology for detection of prion diseases to a US multinational corporation. Dr Stanley has a particular focus on intellectual property and is an inventor on >40 patent applications.
Peter has over 30 years experience in the diagnostics industry in a succession of roles at senior management and board level. Companies including Amersham, Serono, Axis -Shield, Euro-Diagnostica and Epistem. He brings experience of launching successful products on the worldwide market.
He also has experience of the management of investments in research with commercial potential as National Manager for Science, Strategy and Innovation at the Ministry of Business Innovation and Employment in the New Zealand government.
David Allsop’s research area is the pathological role of misfolded 'amyloid' proteins in a range of different human diseases, including some important neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease, and also late-onset diabetes.
His research is concerned with the mechanism of formation and deposition of these protein aggregates, the relationship between protein aggregation and tissue damage, and in novel approaches to diagnosis and therapy.
David Mann is Professor of Neuropathology at Hope Hospital, University of Manchester. Professor Mann began his academic career with a BSc in Zoology before completing a PhD in Neuropathology. He was appointed lecturer in Neuropathology in 1976 and Professor of Neuropathology in 1998. He is a Fellow of the Royal College of Pathologists, and the Royal Society of Medicine.
Professor Mann runs the Manchester Brain Bank, a human brain tissue donation programme, providing neuropathological assessment of tissue to establish neuropathological diagnosis, and acquiring tissues for basic scientific and clinical research into the causes and pathological changes of neurodegenerative diseases.
Professor Mann is leader of the Clinical Neuroscience Research Group within Manchester University Faculty of Medical and Health Sciences, and is co-ordinator of the Manchester Alzheimer’s Disease Research Centre within the Alzheimer’s Research Trust Network. He is a committee member of the British Neuropathological Society.
He has published over 250 scientific papers in addition to 3 books on the neuropathology of dementia, and many review articles and book chapters. A world-ranking authority on the neuropathology of degenerative disorders, he is an invited lecturer on dementia throughout the world.
David Burn is Professor of Movement Disorder Neurology at Newcastle University and Honorary Consultant Neurologist for Newcastle upon Tyne Hospitals Foundation Trust. He is Director of the University’s Institute of Neuroscience, Director of the NIHR Biomedical Research Unit in Lewy Body Dementia and an NIHR Senior Investigator. He is also National Clinical Director for Parkinson’s UK.
David runs the Movement Disorders service in Newcastle upon Tyne, providing a large regional service. He is an Officer of the International Parkinson and Movement Disorder Society, having previously chaired their Congress Scientific Programme Committee. He has published over 240 articles in peer reviewed journals.
The North West Fund for Biomedical and SPARK Impact
The £31m North West Fund for Biomedical, which is managed by SPARK Impact, is part of the £153m evergreen fund provided by the European Investment Bank (EIB) and European Regional Development Fund (ERDF), to supply debt and equity funding to small and medium sized enterprises in the North West of England. The North West Fund for Biomedical is accessible to a broad range of companies including those developing pharmaceuticals, new diagnostics and medical devices, and those working in the fields of clinical research, contract manufacturing and analytical services.