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Annually in the UK ~110,000 donor platelet concentrates are used to prevent bleeding in cancer patients and ~660 newborns are born with an increased risk of bleeding because of a low platelet count caused by maternal platelet antibodies. These newborns and ~10% of the cancer patients require donor platelet transfusions matched for the platelet antibody because non-matched donor platelets are clinically less effective. University researchers have developed better methods for platelet antibody detection and typing and as a direct consequence of this research NHS Blood and Transplant (NHSBT) has from 2009 onwards been able to make platelet transfusions safer and clinically more effective, thereby reducing the number of severe, and on occasions life- threatening, bleeding episodes.
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 conducted by Professor Jo Bradwell at the University of Birmingham provided the basis of the commercially available diagnostic test Freelite®, which quantifies free immunoglobulin light chains in serum and was the first and only assay for the diagnosis and monitoring of Multiple Myeloma (MM). MM is a cancer of immunoglobulin producing plasma cells in the bone marrow. Freelite® has markedly improved the diagnosis and management of MM, is helpful in the diagnosis of all B cell lymphoid neoplasias and provides prognostic information for premalignant conditions present in over 3% of people over 50 years of age. Freelite was commercialised by the University of Birmingham spinout company, the Binding Site, which has achieved worldwide sales, with over 360,000 tests being sold per month in 90 countries and an ongoing 25% annual growth in sales. The company provides annual revenue of £55m and employment for 620 people in the UK and abroad. An improved second generation of tests has been developed by Professor Mark Drayson at the University of Birmingham, which has been commercialised by a second University spinout company Serascience, which started marketing a point of care free light chain diagnostic test worldwide in April 2013.
The production and use of monoclonal antibody, ALK1, by researchers in Oxford has been pivotal in enabling the accurate diagnosis and treatment of Anaplastic Large Cell Lymphoma (ALCL). This research also led to the formal classification of ALK-positive ALCL tumours by the World Health Organization in 2008. While ALCL accounts for 10-20% of paediatric/adolescent non-Hodgkin's lymphoma worldwide, its diagnosis had been problematical due to the absence of suitable reagents. This was remedied in 1997 when Oxford researchers created the first monoclonal antibody, ALK1, recognising anaplastic lymphoma kinase (ALK), a molecule that is associated with up to 90% of ALCL.
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.
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.
Together the University of Aberdeen and Aberdeen city have become a major centre for biologics, the synthesis of medicines from compounds derived from living organisms. Commerce and industry have invested heavily in the process, creating specialist knowledge, jobs and an internationally-recognised network of expertise that promises further growth. This has arisen from ground-breaking research in Aberdeen into the VNAR antibody class that are the smallest binding sites so far identified in the animal kingdom and led to the validation of a new drug discovery platform. Spin-out companies were created (Haptogen Ltd, Cyclogenix Ltd and the pre-commercialisation vehicle Elasmogen) to exploit the emerging technology, which has completed successful efficacy trials in several animal models including late stage pre-clinical models, with trials in humans expected.
The claimed impact is therefore that: spin-outs have been created, highly skilled people have taken up specialist roles in companies; industry and venture money has been invested in patent protected research and development, business has adopted a new technology, award winning industry collaborations have been forged and jobs have been created.
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:
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.
Invasive pulmonary aspergillosis (IPA) is a frequently fatal disease of haematological malignancy patients, caused by fungi from the genus Aspergillus. Dr Christopher Thornton has developed and commercialised a novel point-of-care test for the diagnosis of IPA with an Aspergillus-specific monoclonal antibody (mAb) JF5 generated using hybridoma technology. Using this mAb, he has developed a lateral-flow device (LFD) for the rapid detection of Aspergillus antigen in human serum and bronchoalveolar lavage fluids (BALf) that signifies active infection. Commercial exploitation of the patented technology has been met through the establishment of a University of Exeter spin-out company, Isca Diagnostics Limited.