11 March 2013: A consortium comprising vaccine developer Prokarium Ltd and the University of Birmingham’s Institute of Microbiology and Infection has received an award for ‘advancing the industrial application of synthetic biology’. The £0.4m grant from the Technology Strategy Board (TSB), the UK’s innovation agency, and the Biotechnology and Biological Sciences Research Council (BBSRC) has been earmarked to help fund the development of Prokarium’s Vaxonella® oral vaccine delivery platform as well as two specific vaccine candidates.
Prokarium, a biotechnology start-up company based in Keele, Staffordshire and London, UK, develops cutting-edge genetic technologies to engineer immune-cell-targeting bacteria that express vaccines from within the body, creating the next generation of safe, affordable, oral vaccines. The grant will allow Prokarium to complete preclinical work on its first pipeline product Typhetec®, a dual oral vaccine against typhoid and ETEC, a major cause of diarrhoea. In addition, this grant will enable R&D to commence on a novel vaccine against Clostridium difficile, a major cause of colitis in the elderly.
Currently there are no vaccines against ETEC, a bacterium responsible for between 300,000 and 500,000 deaths annually, including children in developing countries. In addition, every year more than 10 million travellers contract diarrhoea caused by ETEC, which costs €200m annually in medical resources within the EU, and accounts for €450m in lost productivity. Similarly, there is no vaccine against C. difficile, responsible for approximately 900,000 cases of colitis a year across Europe and North America, with an estimated cost of care burden of over $7 billion.
With this funding from the TSB and BBSRC, Prokarium and the University of Birmingham will be able to test candidates that have the potential to be developed into oral vaccines for both the developed and emerging markets.
Carl-Johan Spak, CEO of Prokarium, said:
“We are very pleased that the TSB and BBSRC awarded our consortium this funding, which will not only bring us closer to creating the next generation of oral vaccines against two very important diseases, but also recognises Prokarium as an innovative synthetic biology company.”
Prof Ian Henderson, University of Birmingham adds:
"Prokarium's Vaxonella platform will revolutionise the way we protect people from infectious and non-infectious disease. I am excited by the opportunity to assist Prokarium in the development of an ETEC vaccine based on Vaxonella. Success in this important endeavour will give the gift of life to millions of children who would otherwise suffer or die from this devastating disease"
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Live, attenuated (weakened) bacteria have been used as vaccines for decades (e.g. the BCG vaccine against TB). Prokarium’s Vaxonella technology advances their use as delivery systems for vaccines against a wide range of infectious diseases by modifying the bacteria to produce a foreign protein from the target pathogen, against which an immune response is directed. Vaxonella technology uses live Salmonella bacteria, which have been genetically modified to make them safe, to carry vaccines and deliver them to the immune system via the lining of the gut. The vaccines are produced from self-replicating DNA molecules called plasmids. With conventional bacteria, these plasmids are rapidly lost when the bacterial cells divide. Vaxonella strains incorporate a mechanism called ORT-VAC that prevents plasmid loss without relying on antibiotic resistance genes which otherwise could potentially transfer to pathogenic bacteria.
The advantages of this approach include the elimination of needles, the stimulation of an effective immune response via mucosal surfaces (the entry route for many pathogens) and a simple, cost-effective manufacturing process regardless of the vaccine antigen.
Prokarium has previously shown its ORT-VAC technology to be effective in pre-clinical models against plague, anthrax and tuberculosis.
Prokarium is an early-stage spin-out company from Cobra Biologics, a leading international clinical and commercial manufacturer of biologics and pharmaceuticals. Prokarium develops cutting-edge genetic technologies to create the next generation of oral vaccines. It is developing two pipeline products, a dual oral vaccine against typhoid and ETEC, a major cause of diarrhoea as well as a vaccine against Clostridium difficile a major cause of colitis. Prokarium’s Vaxonella® platform could deliver almost any recombinant protein vaccine orally and, due to the elimination of downstream protein purification, reduce vaccine manufacturing costs by up to 70%. Thus, Prokarium is looking to partner with organisations around the world to develop its Vaxonella® oral vaccine technology platform for other indications.
About the University of Birmingham’s Institute of Microbiology and Infection
Research in Prof Ian Henderson group is focused on understanding the synthesis of bacterial cell-surface components and their interaction with the host. This focus is based on the philosophy that the bacterial cell surface offers a rich source of molecules which can be utilized and adapted to treat or prevent infections. Prof Henderson has been intricately involved in developing vaccines for Salmonella with the Novartis Vaccines institute for Global Health (NVGH). Using murine models he has tested several subunit vaccines for Salmonella and has established correlates of immune protection. He published the first enterotoxigenic Escherichia coli (ETEC) genome sequence in 2008 and has subsequently published the genome sequence of the ETEC H10407 and associated plasmids. Prof Ian Henderson has published over 70 articles in the fields of bacteriology, biochemistry and infection immunology.
About The Technology Strategy Board
The Technology Strategy Board is the UK’s innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit www.innovateuk.org.
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