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Protein modification represents a highly significant and growing source of new products for the biopharmaceuticals market. This case study outlines the development of PolyTherics, a highly successful spin-out company from the UCL School of Pharmacy, and the impact that their enabling technology has had on the pharmaceutical and biotechnology industries. The company was developed as a direct result of new conjugate technology developed by Professor Steve Brocchini and coworkers at the School. The company moved to independent premises in 2006 and now manages a portfolio of over 100 granted and pending patents. Several licensing agreements are in place, including with Celtic Pharma Holdings for haemophilia treatments and Nuron for a multiple sclerosis treatment based on PEGylation conjugation technology. Revenue is expected to be £8m in 2013. The impact of Polytherics is therefore as a significant and effective technology provider to the pharmaceutical and biotechnology industries.
Impact: EaStCHEM spin out Albachem (1994), subsequently incorporated into the Almac group, enabling the latter company to become a world leader in the provision of chemically synthesised proteins.
Significance: Chemical synthesis is competitive with recombinant methods for commercial production of the therapeutic polypeptides that represent ~50% of drugs in big pharma pipelines and have a market value in 2008 of over $13B. The value attributable to Ramage's methods for polypeptide syntheses over the REF period is estimated at approximately £6M.
Beneficiaries: Drug manufacturers, contract research organisations, patients, clinicians.
Research: Studies (1993-6) led by Ramage (at the University of Edinburgh) on new methods for high-yield total syntheses and purification of long polypeptides.
Reach: Almac's protein-manufacturing team remains in the UK with 24 staff members. The Almac Group, headquartered in N. Ireland, has 3300 employees globally (1300 outside UK) and sells to 600 companies worldwide.
Combinatorial Domain Hunting (CDH) technology is a technique for producing fragments of proteins that are soluble and tractable for biophysical analysis. It was developed between 1999 and 2008 at Birkbeck College, in the laboratory of Dr Renos Savva. This technology was patented in 2001 and the biotech company Domainex Ltd was then formed to commercialise it. In 2007, Domainex merged with a UCL spinout company, NCE Discovery Ltd. The company has attracted over £3m in investment and employs about 31 people. In addition to its contract research programme, it has developed an in-house drug discovery programme utilising CDH. Early in 2012 a patent was filed on a series of inhibitors of the protein kinases IKK03b5 and TBK1, which are validated drug targets for cancer and inflammation, and the first of these are expected to begin clinical trials in 2014.
A novel self-assembly process, developed at WestCHEM was shown to provide a step-change for stabilising proteins as dry powders. The spin-out company, XstalBio, was created in 2004 and licensed the patented technology with the aim of developing it for delivery and formulation of therapeutic biomolecules and vaccines. Over the period 2008-2012, eight leading international pharmaceutical and animal health companies paid XstalBio over £2.2M for access to its IP portfolio and to undertake evaluation studies with candidate biomedicines and vaccines. XstalBio employed 8 highly skilled research scientists over this period and 4 further patent families were generated. Boehringer Ingelheim licensed the technology for application to its therapeutic biomolecules and in collaboration with XstalBio built a dedicated €5M pilot plant for manufacture of inhalable dry powders.
Essex research identified a novel bioprocessing matrix which has since been developed into commercial products and recently launched into external markets by Porvair Filtration Group Ltd. The discovery involved the chemical modification of sintered thermoplastic materials in order to attach biological molecules, so conferring highly specific functionalised properties to an otherwise inert base material. This enabled a new approach for protein immobilisation, having technical and practical advantages over existing processes. As a direct result, Porvair has adopted a new technology and invested £900k in R&D over eight years. Essex research has supported a change in business strategy, enabling entry into new markets, which has in turn both safeguarded and created jobs at Porvair.
A computer technology has been invented to accelerate drug discovery. It predicts locations in disease-associated biomolecules where drug molecules could bind, induce shape changes, and thereby bring the activity of the biomolecule under control. A U.S. drug discovery company, Serometrix, has exclusively licensed this technology and incorporated it within their core discovery process. The impact upon them has been:
Bio Nano Consulting (http://www.bio-nano-consulting.com) was established as an operating business in 2007 through a joint venture between Imperial College London and UCL, whose formation was underpinned by research produced by Professor Tony Cass's group at Imperial. The company is the first consultancy in Europe to focus on the increasingly important intersection between bio- and nanotechnology, and it facilitates the development and commercialisation of new biomedical and nanotechnology-based techniques. Since its start-up, the company has attracted numerous clients across the aerospace and diagnostics sectors, including Lockheed-Martin and [text removed for publication]. The company's activities have generated £6M worth of revenue and it has a growing portfolio. The company, which is based in London, currently has 8 full time employees.
Research carried out within Imperial's Life Sciences department led to a collection of new kit solutions to screen the crystallisation conditions of various membrane proteins. These screens were exclusively commercialized by Molecular Dimensions, a UK company, in 2002, 2003 and 2008 under license from Imperial College London. They are the primary screening kit in membrane protein crystallization that is commercially available. These screens have helped to screen the crystallization conditions of a wide range of membrane proteins, leading to many new structures. Molecular Dimensions has sold [text removed for publication] screens, worth more than [text removed for publication], to both academia and industry all over the world.
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.
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.