CHAIN Biotech, Porton Biopharma and Scitech – with funding from Innovate UK – are looking to develop drugs targeting the gut using spores derived from anaerobic bacteria (Clostridia) to deliver therapeutics for inflammatory diseases such as Ulcerative Colitis and Crohn’s Disease.
Clostridia spores are resistant to acid and are able to pass unscathed through the digestive tract to deliver anti-inflammatory payloads in the large intestine.
“Clostridia naturally occur in the colon so are being used as the delivery agent, once they get through the stomach and into the lower intestine where it is anaerobic, they would naturally germinate and release the biotherapeutic,” Phil Luton, marketing manager at Porton Biopharma told this publication.
But there are no industrial capabilities to manufacture the bacteria in the UK, so as part of the project Porton Biopharma will look at the method and how it can be scaled into a pharmaceutical GMP process.
“The aim of this feasibility study is to develop the process from the current lab scale, assess the business opportunity and evaluate a plant/facility design in order to validate the concept and scope the requirements for further development as there is currently no contract manufactures in the UK equipped to manufacture spore based medicines,” said Luton.
Clostridial spore-based medicines
According to CHAIN senior scientist David Kirk, Clostridial spore-based medicines are only a recent development and are not manufactured by any company for therapeutic use.
“The closest products on the market, in terms of production, are Clostridium probiotic supplements in Canada and Japan,” he told us.
“These are produced in anaerobic fermentations, in large bioreactors, similar to how we produce our spores. GMP manufacturing would require adherence to the same principals required of traditional pharmaceutical production.”
Funding details of the consortium have not been divulged, but any investment in a new facility would be in a further round.