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”.
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.