Partnership includes a Phase II clinical trial using Medical Research Council (MRC)-funded microbiome therapies with the goal of boosting allo-HCT in patients suffering from hematologic malignancies
Therapeutic company EnteroBiotix Limited (EBX) has partnered with Imperial College London (Imperial) to develop microbiome R&D in blood cancer patients and accelerate systematic research in the emerging science of the microbiome.
EBX and Imperial are partnering to administer a Phase IIa investigator-initiated trial to assess how EBX-102 impacts outcomes for bone marrow transplant blood cancer patients. This trial is part of the Microbiota Transplant Before to Allogeneic Stem Cell Transplantation (MAST) study, conducted at six of the UK’s leading blood cancer centers and includes, along with Imperial, UCLH, The Royal Marsden, King’s College London, Leeds Teaching Hospitals, and Birmingham University Hospitals.
EBX will provide its lead product, EBX-102, from its MHRA-licensed facility for the clinical trial. EBX-102 contains diverse microbiota ecosystems obtained from rigorously selected healthy donors, offering a pharmaceutical product that is consistent in composition with attractive commercial attributes. EBX’s manufacturing capabilities include its novel, proprietary AMPLA platform that enables the 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) that demonstrated early signs trending toward gut microbiota transplantation (IMT), reducing complications and improving survival. Imperial will further explore the efficacy of this approach for a variety of diseases, as well as strengthen the path to commercialization through systematic research.
Professor Julian Marchesi from Imperial College London, Department of Metabolism, Digestion and Reproduction, who is leading the research, says: “Patients with cancers of the blood are a group whose gut microbiome is particularly under attack. They often receive strong chemotherapy, which has side effects of mouth ulcers and intestinal inflammation. Their nutrition may be poor, they frequently receive antibiotics due to their high infection rate, and many of them end up colonized with antibiotic-resistant bacteria.
This last point in particular can be a problem when patients need very demanding treatment, such as bone marrow transplantation; hematologists are sometimes eager to offer this or other treatments because patients are at very high risk for an infection that is untreatable. Therefore, we are very excited and pleased to partner with EnteroBiotix to use their product to manipulate the gut microbiome in these patients.”
It’s helping build a strong case for microbiome improvement. The Imperial team is an engine of discovery, and EnteroBiotix can help translate it into a commercial product that benefits patients around the world.
Dr. James McIlroy, Founder and CEO of EnteroBiotix, said, “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 people to sick people can contribute to better health outcomes. EnteroBiotix is developing a more secure and scalable approach to IMT that is consistent in composition and backed by a strong intellectual property position. Partnering with Imperial allows us to explore different research opportunities and brings us closer to fulfilling our vision of developing products that benefit patients.”
“The first data so far generated by Imperial is very exciting,” added Dr. McIlroy. “It is helping to build a strong case for microbiome improvement. The Imperial team is an engine of discovery and EnteroBiotix can help translate that into a commercial product that benefits patients around the world.”
EnteroBiotix products have potential applicability in multiple disease areas, including immuno-oncology and liver-brain axis diseases.
EnteroBiotix’s state-of-the-art GMP manufacturing facility will support further research, which was recently granted an investigational medicinal product (IMP) manufacturer’s license by the Medicines and Healthcare Products Regulatory Agency (MHRA). acronym) to manufacture candidate microbiome products for clinical trials.