Microbiome Report for Week Ending 12/1/18

Evelo Biosciences Announces First Dosing in Phase 1b Clinical Trial of EDP1815 in Psoriasis and Atopic Dermatitis

Evelo Biosciences, Inc. (NASDAQ:EVLO) (“Evelo”) a clinical-stage biotechnology company developing monoclonal microbials to engage immune cells in the small intestine and drive changes in systemic biology, today announced first dosing in its Phase 1b clinical trial of EDP1815 for the treatment of psoriasis and atopic dermatitis. EDP1815 is Evelo’s second monoclonal microbial product candidate being developed for the treatment of inflammatory diseases.

"Psoriasis and atopic dermatitis patients are underserved by current medicines, particularly in the moderate patient populations, where the potential efficacy, tolerability and convenience benefits of monoclonal microbials could be profound," said Andrea Itano, Ph.D., head of immuno-inflammatory diseases at Evelo. "Monoclonal microbials may also have broader therapeutic applicability for many other inflammatory diseases. Alongside the disease-specific exploratory endpoints for atopic dermatitis and psoriasis, this study will also measure biomarkers such as Th1, Th2 and Th17, which may help define the potential for EDP1815 to treat a broader range atopic and arthritic diseases."

About Clinical Trial EDP1815-101
EDP1815-101 is a placebo-controlled Phase 1b that will investigate the safety and tolerability of EDP1815 in 96 healthy volunteers and in patients with mild or moderate psoriasis or atopic dermatitis. Exploratory endpoints include the effect of EDP1815 on validated clinical measures of disease and a range of additional pharmacodynamic markers. Evelo expects to report initial clinical data from this trial in the second half of 2019.

Kaleido Biosciences Industry Veteran as Chief Medical Officer and Head of Research & Development

Kaleido Biosciences, a healthcare company with a differentiated, chemistry-driven approach to leveraging the potential of the microbiome organ, today announced the appointment of Katharine Knobil, M.D., as chief medical officer (CMO) and head of research and development. Dr. Knobil joins Kaleido from GlaxoSmithKline (GSK), where she most recently served as CMO, and spent more than 20 years in roles of increasing responsibility in clinical development, health outcomes and medical affairs. She will report to Kaleido’s chief executive officer, Alison Lawton.

As CMO at GSK, Dr. Knobil oversaw medical affairs, health outcomes, global clinical safety and medical governance across the pharmaceutical, vaccines, and consumer businesses. Previously she served as CMO for Pharmaceuticals at GSK from 2015 to 2017, and prior to that, was senior vice president, value evidence and outcomes. Dr. Knobil first joined GSK in 1997 as a research physician in respiratory clinical development, and subsequently held a number of roles, including leading the European respiratory clinical team, and building the late-stage clinical development for all therapeutic areas in China. Dr. Knobil was recently named one of 2018’s Fiercest Women in Life Sciences by FiercePharma. She has served on the Board of Directors of the National Health Council and has been active with the National Academies of Sciences, Engineering, and Medicine, and the Patient Centered Outcomes Research Institute.

Vedanta Biosciences Announces Initiation of Phase 1 Clinical Study with Janssen of Microbiome-Derived Product Candidate for Inflammatory Bowel Disease

Vedanta Biosciences announced on 11/27/18 the initiation of a Phase 1 clinical study in healthy volunteers of VE202, the Company’s orally-administered, live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD). The study is being conducted by Janssen Research & Development, LLC.  In conjunction with the initiation of this study, Vedanta Biosciences will receive $12 million from Janssen in milestone payments as part of an ongoing collaboration that has development and commercialization milestone payments of up to a total of $339 million in addition to royalty payments.

 “There is significant evidence highlighting the role of the microbiome in the pathogenesis of IBD. Current treatments effectively block mediators of inflammation, but they do not address the underlying alterations in the gut microbiota that may be driving the inflammation in the first place, leaving a need for safe approaches that address this aspect of the disease,” said Bernat Olle, Ph.D., Co-founder and Chief Executive Officer of Vedanta Biosciences. “To our knowledge, VE202 is the first drug candidate based on a rationally-defined bacterial consortium to enter the clinic for an autoimmune disease. We are pleased to collaborate with Janssen’s team, which has produced several important drugs for people living with IBD.”

VE202 is based on the work of Vedanta Biosciences co-founder Kenya Honda, Ph.D., of Keio University, who in 2011 published in Science foundational research demonstrating that members of the gut microbiota could impact the number and activity of regulatory T cells in the gut mucosa. In two further publications in Nature, in collaboration with Vedanta Biosciences, Honda’s group identified cellular mechanisms driving these and other immune-microbiota interactions and demonstrated their potential utility in disease models. Informed by this work, Vedanta Biosciences advanced VE202, a drug candidate consisting of a rationally-defined consortium of regulatory T cell – inducing bacteria.

“Randomized clinical trials of fecal microbiota transplants (FMT) have provided strong evidence for the microbiome’s involvement in inflammatory bowel diseases albeit with varying clinical success depending on the donor used and the frequency of instillations. The inconsistent composition of fecal donor material and the need for chronic administration make FMT a challenging modality for treating IBD,” said Balfour Sartor, M.D., Midget Distinguished Professor of Medicine, Microbiology & Immunology and Co-Director of the UNC Multidisciplinary IBD Center at the University of North Carolina at Chapel Hill. “I believe that a better, more consistent therapeutic approach is to use a well-characterized, rationally-defined, and orally-delivered LBP using bacterial species normally found in the intestine of healthy subjects. I am encouraged by the work Vedanta Biosciences is conducting, and I look forward to the results of this latest clinical study.”