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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.
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.
Innovative formulation science to create and develop the commercially successful PowderHale® technology was undertaken within the Department of Pharmacy & Pharmacology at the University of Bath, and subsequently by Vectura. This has directly provided the basis for novel, potentially life-saving treatments for chronic obstructive pulmonary disease (COPD). Seebri® Breezhaler® and Ultibro® Breezhaler® are once-daily, maintenance bronchodilators for the relief of various symptoms due to airways obstruction caused by COPD. Seebri® Breezhaler® was approved in the EU and Japan at the end of 2012 and has now been launched by Novartis. Ultibro® Breezhaler® a first-in-class combination bronchodilator was approved in Japan and the EU in September 2013. Under the terms of the licence agreement with Novartis concerning these products, Vectura has already received $52.5M with an additional >$100M anticipated upon achievement of regulatory and commercialisation targets. These medicines are major advances to treat and manage a disease that, according to the WHO, affects an estimated 210 million people worldwide and was the third leading cause of death in the developed world in 2012.
Biomedical devices that need to be implanted into the body typically experience the so-called foreign-body reaction: proteins adhere to the surface of the devices, leading to rapid loss of function and, eventually, to a requirement for replacing the device. Between October 2006 and September 2011, The University of Reading, in collaboration with the UK SME BioInteractions Ltd., developed and evaluated a range of new polymers for coating implantable biomedical devices, especially coronary stents and catheters. The result was a coating system that can deliver a drug controllably over a pre-defined period, leading to the commercial biomaterials platforms AdaptTM and AssistTM. This work resulted in capital investment by Biointeractions Ltd and a substantial increase in their research staffing.
The health of people who inject illicit drugs, the formulation of harm-reduction policies, and the work of associated businesses and social enterprises have all benefited from the University's laboratory and practice research into the safety and efficacy of materials and equipment used in needle-exchange programmes. The research has informed the development of safer acids for injection preparation, safer injecting paraphernalia (e.g., spoons and filters) and an information film which has been distributed from needle exchanges on DVD and viewed over 50,000 times online. The research has led to enhanced support and protection for injecting drug misusers, and to advances in harm reduction in the UK, France and Canada.
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:
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.
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.
A new, more structured way of assessing the various harms done to individuals, families, communities and wider society by a range of legal and illegal drugs was first articulated by Professor David Nutt and colleagues at the University of Bristol. The "rational scale" they developed in the light of their research has stimulated extensive policy debate and informed drug classification in the UK and overseas. The research underpinning the scale has been disseminated through numerous public lectures and discussions and has stimulated worldwide media coverage. As a consequence, public awareness of drug harms has increased and public engagement in important debates about drugs has intensified.
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: