EnteroBiotix Limited (EBX) has partnered with Imperial College London (Imperial) to develop microbiome R&D in patients suffering from blood cancer as well as accelerate systematic research in the new science of the microbiome.
EBX and Imperial are partnering to manage a Phase IIa investigator initiated trial, to evaluate how EBX-102 impacts on outcomes of bone marrow transplant patients with blood cancer. This trial forms part of the Microbiota Transplant Prior to Allogeneic Stem Cell Transplantation (MAST) study, run across six of the UK’s leading blood cancer centres and includes, along with Imperial, UCLH, The Royal Marsden, King’s College London, Leeds Teaching Hospitals, and University Hospitals Birmingham.
EBX will provide its lead product, EBX-102, from its MHRA licensed facilities, for the clinical trial. EBX-102 contains diverse ecosystems of microbiota obtained from healthy and rigorously screened donors, offering a compositionally consistent drug product with attractive commercial attributes. EBX manufacturing capabilities include its novel proprietary AMPLA platform that enables rapid preparation of dry powder from hydrated starting material.
The Medical Research Council funded trial, supported in-kind by EnteroBiotix, will build on Imperial’s successful pilot study (in the same patient population) which demonstrated preliminary signals trending towards intestinal microbiota transplantation (IMT), reducing complications and improving survival. Imperial will increase exploration into the efficacy of this approach for a range of diseases, as well as to strengthen the route to commercialisation through systematic research.
Professor Marchesi of Imperial College London, Department of Metabolism, Digestion and Reproduction, leading the research says: “Patients with blood cancers are a group whose gut microbiome is particularly under attack. They often receive strong chemotherapy, which has side effects of mouth ulcers and gut inflammation.
“Their nutrition might be poor, they receive frequent antibiotics because of their high rate of infections, and many of them end up colonised with antibiotic-resistant bacteria. That latter point in particular can be a problem when patients need a very demanding treatment, like bone marrow transplantation; haematologists are sometimes anxious about offering this or other treatments because patients are at such high risk of getting an infection which is untreatable.
“So, we are very excited and pleased to be partnering with EnteroBiotix to use their product to manipulate the gut microbiome in these patients.”
Dr James McIlroy, founder and CEO of EnteroBiotix, says: “When we founded EnteroBiotix there were 13 clinical trials listed on clinicaltrials.gov investigating IMT, now there are hundreds. Most of the studies published so far show the same thing – that transferring microorganisms from healthy to sick people can contribute to improving health outcomes.
“EnteroBiotix is developing a safer and more scalable approach to IMT that is compositionally consistent and is supported by a strong intellectual property position. Partnering with Imperial allows us to explore different research opportunities.”
“The early data already generated so far by Imperial is very exciting,” he adds. “It is helping to build a strong case for microbiome enhancement. The Imperial team is a discovery engine and EnteroBiotix can help translate that into a commercial product that benefits patients around the world.”
EnteroBiotix’s products have potential applicability across multiple disease areas including immuno-oncology and diseases of the liver-brain axis.
Further research will be supported by EnteroBiotix’s state-of-the-art GMP manufacturing facility that recently was granted a Manufacturer’s licence for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture microbiome product candidates for clinical trials.