Clinical OMICS

NOV-DEC 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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28 Clinical OMICs November/December 2017 www.clinicalomics.com planted with a responder microbi- ome did much better on therapy than those with a non-responder microbi- ome," said Gopalakrishnan. Wargo and Gopalakrishnan hope to conduct human clinical trials of can- cer patients based on their findings in mice. While currently the planning stages, the team hopes the first trials will start before the end of 2018. Implicated in MS Imbalances in the gut microbiome have also been linked to a number of other conditions including multiple sclerosis (MS). Ashutosh Mangalam, Ph.D., from the University of Iowa, and his team are one of several groups that have observed such imbalances in MS patients. He explained: "Based on the published MS microbiome studies we can say that patients have higher abundance of gut bacteria with proin- flammatory characteristics and a lower abundance of gut bacteria with anti-inflammatory capabilities." In a recent study, Mangalam and his colleagues showed that the bac- teria Prevotella histicola could sup- press disease in a mouse model of MS. These findings are supported by reports from other groups that MS patients have a lower abundance of Prevotella species compared to people without the condition. "Based on these findings we can hypothesize that bacteria belonging to the Prevotella genus are anti-inflam- matory and might be used in future as a potential treatment option for MS patients," suggested Mangalam. Simplicity is Key While a large portion of the research being carried out in this area focuses on the gut microbiome, a number of researchers are investigating micro- (continued from previous page) James McIlroy has still to complete his medical training at the University of Aber- deen, Scotland, but is already CEO of his own company EnteroBiotix. Speaking to Clinical Omics, he shared his motivations and inspirations. "In 2013, I took a year out of medicine to study an Intercalated Degree at the University of Edinburgh. During that year, I became really interested in the bacte- ria that live on and inside of us." Inspired by the 2013 NEJM paper using fecal transplants to treat C. difficile infec- tion, but disappointed by the methods he observed being used to carry out these procedures, McIlroy decided to take mat- ters into his own hands. "In the hospital, I'd seen blood-derived products being ordered from the blood bank and I couldn't understand why we didn't have something similar in place for fecal transplantation. There was no licensed facility the doctors could order from. Also, it was administered through a variety of invasive medical procedures like colonoscopy, enema, and nasal duodenal tubing." He added: "I thought if we could encapsulate this and manufacture it in a facility that held a license by a competent authority, then we would solve a lot of prob- lems for these doctors; hopefully treating a lot of patients and also potentially saving the [U.K.'s National Health Service] quite a bit of money." This led to the birth of EnteroBiotix. Several years down the line and a large amount of hard work later, the progress that McIlroy and his colleagues have made has recently been recognized by the injection of a £500,000 (US$655,652) seed investment. The company is developing a closed system to allow processing and storage of fecal samples without exposure to the environment. "We plan to do that all within the collection device. This will allow us to process the sample in an oxygen-free environment and means we can add bugs in or add products into donations to knock certain bugs out," explained McIlroy. A secondary application the company is developing is a process that allows encapsulation of the fecal microbiome in a scalable and standardized manner. "Our focus is on making fecal transplants as safe and effective as possible for patients and as accessible as possible for researchers that wish to use the results of successful fecal transplant studies to inform the design of their next-generation microbial therapies," said McIlroy. When asked about how EnteroBiotix fits into the microbiome space, he com- mented: "There is a spectrum of different strategies that are being piloted and developed. Some companies are working on small molecules, some on defined cocktails of bugs and some on single strains. As far as I am aware, none of these strategies has successfully been through a Phase III clinical trial, however, which shows that the field really is in its infancy." —Helen Albert n How Safe are Fecal Transplants? EnteroBiotix Promises Standardization and Encapsulation James McIlroy, CEO of EnteroBiotix.

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