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Southampton research underpins the clinical development of a new class of anti-cancer monoclonal antibodies (mAb), such as anti-CD40, anti-CD27 and anti-CD20. The most advanced is a next generation, fully human drug, ofatumumab (commercialised by GlaxoSmithKline/Genmab; trade-name Arzerra) approved in Oct 2009 to treat advanced chronic lymphocytic leukaemia. Its approval was based on a 42% response rate in patients who had failed current `best in class' treatment. Arzerra is now a multi-million dollar drug, launched in 26 countries (and growing) and is being used in 19 on-going clinical trials worldwide for diseases ranging from lymphoma to rheumatoid arthritis and multiple sclerosis. Southampton's work has inspired follow-on funding from government and industry in excess of £12m.
Kidney disease affects about 10% of the population and 10% of these patients develop established kidney failure (ERF). Transplantation is a better treatment for ERF than dialysis but is limited by acute and chronic graft rejection. Treatment of rejection mediated by the recipient's T-lymphocytes is now remarkably successful, but antibody-mediated rejection (AMR) remains challenging. A principal cause of AMR is recipient antibodies targeting human leukocyte antigen (HLA, also known a tissue type) on the transplant organ. The presence of such antibodies previously vetoed transplantation but in the last ten years it has become increasingly feasible to transplant across HLA antibody barriers. Research at the University of Warwick (UoW) by Dr Daniel Zehnder and Professor Robert Higgins has facilitated and accelerated this process. Their research includes the first detailed monitoring of antibody levels after transplantation, showing how these affect graft function, and the development of new techniques to remove antibodies from patients. This resulted in over 100 HLA-mismatched renal transplants taking place in Coventry giving a net saving to the NHS of over £5M. Their research and its clinical translation encouraged the performing of another 350 such transplants across the UK and initiation of the National Case Registry.
Research into modified Fc regions for therapeutic antibodies has resulted in the development of antibodies with novel and optimised functions. An aglycosylated anti-CD3 antibody called otelixizumab has reached phase 3 clinical trials with GSK and a novel antibody for treatment of fetomaternal alloimmune thrombocytopenia has been tested in human volunteers. The patented technology has been licensed to Pfizer and to GSK for incorporation into their therapeutic antibody programmes with four of these already in clinical trials (tanezumab, ponezumab, RN316 & RN564). Licensing revenue totalling £3.2 million has been returned to the University's company Cambridge Enterprise Ltd in the impact period. In addition, consultancy and advisory services on antibody engineering have been provided to a number of other biopharma companies.
BioAnaLab's mission is to advance innovative biopharmaceuticals, such as therapeutic antibodies for cancer treatment, into the clinic. From 1995, the University of Oxford pioneered methodology essential for validating top quality therapeutic antibodies and monitoring their activity in patients. This expertise led to the establishment in 2002 of BioAnaLab, a successful Isis Innovation spin-out company. By 2009 BioAnaLab employed 50 staff providing analytical services to approximately 100 pharmaceutical and biotechnology companies worldwide and had annual sales exceeding £3.13 million. BioAnaLab was subsequently acquired in 2009 by Millipore Corporation to become an integral part of Merck/Millipore's global drug discovery unit.
Research by Dr Andrew Martin at the UCL Research Department of Structural & Molecular Biology has led to a series of antibody-related tools being made available for free use over the Web. One of these, Abysis, has been visited over 360,000 times by over 8,000 users. Abysis has also been released under a commercial license and has been purchased by companies ranging from small biotechs to large pharma for use in their antibody therapeutic development pipelines, allowing them to identify unusual features of their sequences and to improve strategies for humanisation. Martin has also acted as an expert witness for drug companies in patent disputes.
The spin-out company, Degrasense, has developed and protected intellectual property of technology capable of quantifying specific proteolytic enzymes through changes in electrochemical responses (impedance) at electrodes due to the enzymatic degradation of polymer coatings. The company has detected several specific proteases that are relevant to the monitoring and treatment of a number of conditions including: periodontal disease, multiple sclerosis, haemophilia and hypertension. The technology is currently being validated in a clinical trial as a point of care sensor for the detection of active periodontal disease. Point-of-care sensors provide immediate, low-cost test results in non-laboratory settings, offering a more patient-centred approach to healthcare and earlier detection of disease.
The spin-out company Intelligent Fingerprinting Ltd. was founded in 2007, based on Professor David Russell's research. The company develops novel technologies using antibody-nanoparticle reagents to detect drugs and drug metabolites in latent fingerprints whilst simultaneously providing high resolution fingerprint images for identification purposes. Combining these technologies with a fluorescence-based hand-held reader provides a non-invasive diagnostic platform for use in the criminal justice sector, institutional testing and hospital environments.
Total funding to date for the company has been >£3.2M in four investment rounds. The company employs 11 staff, who work in dedicated office and laboratory premises within the Norwich Research Park Innovation Centre.
The company received its first purchase order from the UK Home Office in 2012. A distribution agreement is in place with Dallas-based SmarTox Inc. for North American sales of Intelligent Fingerprinting products for `Drugs of Abuse' testing.
Proteins are fundamental to life and to many drugs, vaccines and new types of applied medicine with engineered cells. For this work, it is often essential to tag proteins to enable their identification and purification. The V5 tag, which was developed in St Andrews, is used very widely in this role and has some key advantages over alternatives.
Key impacts are:
Research into novel immunotherapies has given rise to a novel drug (EtxB), which is now in Phase II clinical trials, and to a profitable contract research company partnering with the pharmaceutical industry to develop their compounds. Trident Pharmaceuticals was formed around patents filed by the University of Bristol, has received investment of [text removed for publication], successfully completed Phase I trials (2011) and is in the midst of Phase IIa trials in humans with inflammatory disease (2013). KWS BioTest arose as a result of the underpinning research and experience gained from developing EtxB, and is now a leading contract research organisation working with pharmaceutical and biotechnology companies developing novel treatments for human disease. KWS has directly contributed to the development of therapies at more than 75 different companies, employs 28 people, has exported [text removed for publication] and was 2012 winner of a Biomedical iNet Award for outstanding business achievement.
The University of Aberdeen's discovery of a novel drug for the treatment of rheumatoid arthritis and related inflammatory/autoimmune disorders has brought substantial industrial investment in research and development. The new drug is expected to enter clinical trials shortly and has the potential to transform the way rheumatoid arthritis is currently treated, as few patients currently have access to the expensive biological agents which dominate existing therapy. Aberdeen has commercialised its research into a university spin-out company and subsequently licensed the programme to a UK drug-development company, Modern Biosciences plc. The research has created and protected UK expertise and jobs.
The specific impacts on commerce have been: substantial industrial investment in research and development, job creation and protection within UK industry, commercialisation of a new product via a licencing deal, and academic consultancy in industry.