UK biotech to manufacture novel medicines for Inflammatory Bowel Disease using spores of gut bacteria
Three leading British biotechnology businesses have obtained grant funding from Innovate UK to investigate the manufacture of a new class of medicines, targeting a range of clinical conditions through interaction with the human microbiome.
The novel and highly innovative approach is to use spores derived from anaerobic bacteria (Clostridia) that are naturally found in our large intestines to deliver targeted anti-inflammatory therapeutics. Bacterial spores are resistant to acid, so when ingested in a tablet or capsule they are able to pass largely unscathed through the stomach before germinating and releasing the anti-inflammatory bio-actives (payload) to where it is needed in the colon, to treat chronic and debilitating inflammatory conditions, such as Ulcerative Colitis and Crohn’s Disease.
The concept has been proven in pre-clinical tests by the project consortium lead CHAIN Biotechnology, but until now a stumbling block has been the lack of a biopharmaceutical manufacturing facility in the UK, able to scale-up and manufacture Clostridial spore-based medicines to the required standard, following good manufacturing practice (GMP), needed for medicinal products for human testing and use. This is where Porton Biopharma with its knowledge and history of developing and producing bio-therapeutics from various spore-forming bacteria, and Scitech which specialises in design, engineering, construction and validation of facilities within the life-science sector will add their expertise.
Developing and testing the technological approach of microbiome targeted therapeutics, and being first in the market with an advanced medicine manufacturing capability and capacity required for such products, would see CHAIN Biotechnology and the UK taking a step closer to becoming world-leaders in this fast growing emerging health care area.
Dr Basil Omar CHAIN’s Co-Founder and Chief Commercial Officer said “The output of this feasibility project will support the business case for further investment in a dedicated, advanced manufacturing facility for these breakthrough therapeutic products offering medical treatments and delivering real benefits for long-suffering patients”.
Dr Roger Hinton MD of Porton Biopharma said “This is an ideal fit for us given our history of developing biopharmaceuticals from spore formers, knowledge of GMP manufacture and specialised containment microbiology. We are very excited by the commercial potential.”
Dave Grant MD of Scitech said “Life sciences are an essential part of the UK government’s new industrial strategy and this award facilitates the creation of much needed new specialist manufacturing industrial infrastructure with new highly-skilled jobs”.
Note to editors:
CHAIN Biotechnology Limited was founded in 2014, by serial entrepreneur Dr Edward Green, to exploit the therapeutic potential of Clostridia bacteria found in the human gut microbiome. CHAIN’s innovative platform technology supports a product pipeline, developed through the identification and delivery of small molecules, peptides and natural metabolites that interact positively with the gut microbiome. CHAIN is targeting a broad range of clinical conditions including control of infection and inflammation in the gut as well as interacting with signalling receptors in the gut which have an effect on the Central Nervous System, with potential new treatments for such conditions as depression and neurological disorders.
Porton Biopharma Limited (PBL) manufactures a number of biopharmaceutical products including the UK’s anthrax vaccine and Erwinase®, a treatment for childhood leukaemia. It has state-of-the-art cGMP pharmaceutical manufacturing facilities which are licensed by the MHRA & FDA and employs approximately 300 people. PBL is registered in England and Wales under company number 9331560. It was commercialised from Public Health England (PHE) in 2015 to enable it to be better placed to develop the business of developing & manufacturing life-saving biopharmaceutical products.
Scitech Engineering Ltd are specialists in design, engineering, construction and validation for the pharmaceutical, biotechnology and life science sectors. Formed in 2002 Scitech is an employee owned, highly specialised and skilled business offering a full range of engineering, construction and professional services.
Inflammatory Bowel Disease (IBD) is a chronic and debilitating set of diseases characterised by inflammation in the lower digestive tract. The most common conditions are Ulcerative Colitis and Crone’s Disease. In the EU, IBD affects 2.6M people with annual healthcare costs of >£4.5Bn. IBD is more common in industrialised nations although incidence is rapidly increasing globally, driven by pursuit of ‘westernised’ lifestyles in developing countries.
Innovate UK is the UK’s innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. For further information visit www.innovateuk.gov.uk
For more information contact
CHAIN Biotech: Dr Basil Omar, Chief Commercial Officer on 0777 166 0800 firstname.lastname@example.org
Porton Biopharma: Dr Phil Luton, Commercial & marketing Manager on 01980 619723 or 07342 056193 email@example.com
Scitech: Rachel Slater, Business Development Manager on 01483 270 524 firstname.lastname@example.org
CHAIN has been awarded £0.5M grant funding from Innovate UK, the UK’s Innovation agency, to expand its range of biotechnology products. Building on a successful synthetic biology program, the grants support further development of CHAIN’s proprietary Clostridium platform for therapeutic and specialty chemical applications.
A two-year project will focus on the development of novel therapeutics targeting gut-related disease. CHAIN has successfully demonstrated the use of Clostridium to deliver small molecules to the gut. In this project, we will expand the range of therapeutics to include anti-microbial and anti-inflammatory peptides. This work will be carried out in collaboration with leading researchers in Clostridium genetics at the Synthetic Biology Research Centre (SBRC) at the University of Nottingham.
The second project focuses on the production of high-value chiral chemicals. CHAIN has already successfully developed a Clostridium strain that produces (R) 1,3 butanediol, an important building block for several nutraceutical and pharmaceutical products. In this project, we plan to improve microbial performance and deliver a cost-completive fermentation process for chemical production.
CHAIN is currently focused on the testing and progression of its lead gut microbiome therapeutic for the clinic, targeting inflammatory bowel disease.
Dr Edward Green, Chief Executive at CHAIN comments
“Grant funding supports our highly skilled discovery team, based at the SBRC and strengthens ties with the Centre. Ultimately, this serves to build and accelerate our product discovery pipeline without undue distraction from our lead product.”
This article first appeared on chainbiotech.com on 09/09/2017 and was covered by SynBioBeta synthetic biology news: https://synbiobeta.com/chain-awarded-0-5m-grant-funding-develop-healthcare-platform/.
LONDON, UK, 10 AUGUST 2016 — CHAIN Biotechnology Ltd has successfully completed a 12-month research project entitled “Chiral Chemical Synthesis in Clostridia”. The research was supported by a grant from Innovate UK, the UK’s innovation agency.
Specifically, CHAIN has demonstrated a new way to change the stereochemistry of intracellular metabolism in Clostridia bacteria, resulting in the re-direction of carbon flow towards R-chiral chemicals rather than the natural S-form. This change in stereochemistry, referred to as the “Chiral Switch™”, resulted in the production of two new renewable chemical products; 1,3 butanediol and 3-hydroxybutyrate.
During this project, CHAIN demonstrated the technical feasibility of applying the Chiral Switch™ technology in several different species. The genetic modification was stabilised using advanced genetic tools to achieve chromosomal integration, and the fermentation conditions were optimised to increase product yield.
The chiral purity and delivery of chiral chemicals in the correct R-enantiomeric form is critical to ensure safety and efficacy, especially when formulated into nutritional and pharmaceutical products. Currently, chiral chemicals are manufactured as by-products from oil-refining through unsustainable, complex and often costly chemical synthesis processes. In contrast, CHAIN’s Chiral Switch™ technology provides a new fermentation method for the production of specific R-chiral chemicals. The technology supports a cheaper, cleaner and more sustainable route to these high value chemicals.
Clostridium is a genus of bacterium proven for industrial chemical production. Solvent producing strains have been used for commodity chemical (acetone and butanol) fermentation since the early 1900s. Recent technological breakthroughs have allowed the genetic manipulation of these economically and industrially important bacteria, unlocking their potential to make higher value fine chemicals.
Edward Green, Chief Executive says, “CHAIN uses advanced gene editing tools for Clostridia and has demonstrated for the first time the use of synthetic biology for the production of novel and specific chiral chemicals in Clostridium. Our proprietary Chiral Switch, we have exemplified and patented, is a powerful mechanism that unlocks the commercial viability of the Clostridium chassis. This important breakthrough supports the production of specific high value chiral chemicals and demonstrates CHAIN’s technology leadership with Clostridium bacteria. This innovation provides us with a significant competitive advantage for high value products and we are working with industry partners to translate the research into commercial opportunities.”
CHAIN Biotechnology Ltd. (CHAIN) is an early-stage biotechnology Company based at Imperial College, London and the University of Nottingham. The Company aims to develop and exploit Clostridium bacteria for a wide range of high value biotechnology markets and applications. CHAIN has recruited a team of experts and assembled world class partners to build an advanced technology platform for Clostridium. The Company deploys proprietary “cutting edge” synthetic biology methods to improve production characteristics in strains selected from our unique collection of industrial strains. Quite simply CHAIN is the “Clostridia Technology Company”.
London, UK, 23 December, 2015
CHAIN has successfully completed its first round of seed funding last month with the support of a consortium of business angels based in the UK. Business angels are investors who bring expertise and provide start-up capital. CHAIN will use the funds to strengthen its unique technology platform based on the development of advanced microbes for the production of high value chemicals.
CHAIN also welcomes Robert Rickman and Paul Green to the Board of Directors. Mr Rickman will act as Chair and Mr Green joins as a non-executive director. Mr Rickman is a Partner in Rockley Group and holds MA and MSc degrees from the University of Oxford. He is a director at Schroder UK Midcap Investment Trust plc and Carclo plc, as well as a number of private companies. Mr Green has over 25 years of professional management experience with leading multinationals in global and Middle East-focused roles.
Dr Edward Green, Chief Executive of CHAIN, comments, “We are delighted to complete our first investment which provides early validation of our business model. I am also pleased to welcome Paul and Robert to the Board. Both have a wealth of financial and business acumen that will prove invaluable as CHAIN transitions from an early stage business towards a technology and market leader in Industrial Biotechnology.”
CHAIN operates at two sites; Imperial College, London and the SBRC at the University of Nottingham.
Central to CHAIN’s business proposition is the provision of a New and Advanced Anaerobic Fermentation Technology Platform for a variety of Industrial Biotechnology products and applications. CHAIN are very interested in forming development partnerships with companies interested in novel reductive enzymes, anti-microbials, bio-polymers & fine/speciality chemicals. To discuss how our CHAIN’s platform may offer advantages for your particular applications contact Business Development manager Ben Bradley. Ben.email@example.com
Dr David Kirk