Microbiome Report for Week Ending 5/18/19

May 26, 2019

Microbiome Report for Week Ending 5/18/19

4D Pharma's Chron's Disease Treatment Meets Safety Objective
4D pharma plc (AIM: DDDD), a pharmaceutical company focusing on the development of Live Biotherapeutics, announced on 4/16/19 that data from the completed Phase Ib clinical study of Thetanix for the treatment of Crohn’s disease will be presented on 18 May in a poster session at the 2019 Digestive Disease Week meeting in San Diego. The poster was nominated as a “Poster of Distinction” within the top 10% of posters submitted to the congress. The Company has previously announced the top-line results from this study.

The randomised, double-blind, placebo-controlled study was conducted in two parts, with a single-dose phase and a multiple-dose phase and treated a total of 18 adolescent patients with Crohn's disease. In the single-dose phase, eight subjects were given a single dose of either Thetanix or placebo. In the multiple-dose phase, 10 subjects were given either Thetanix or placebo twice daily for seven consecutive days.

This study met its primary objective, demonstrating that Thetanix was well tolerated with a good safety profile.

The Lead Investigator Richard Hansen, Consultant Paediatric Gastroenterologist, Royal Hospital for Children, Glasgow will also give an oral presentation on this data at the 52nd Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) in Glasgow, UK, on 7 June 2019.

Azitra, Inc.Expands Research and Development Teamto Support Clinical Development Program
FARMINGTON, CT (May 16, 2019): —Azitra, Inc., a clinical-stage medical dermatology company addressing adverse skin conditions by harnessing the microbiome, announced on 5/16/19 the appointment of two distinguished scientists to expand the technical team and lead theexpansion of its development programs.Travis Whitfill, co-founder, will continue to serve as Chief Scientific Officer.
●Trudy H. Grossman, Ph.D., will serve as Vice President of Research;
●Roger Léger, Ph.D., will become Vice President of Chemistry, Formulation and Development.

“Dr. Grossman has extensive research experience in bacterial genetics, microbiology and molecular biology, and has led several drug discovery and preclinical programs, supporting the clinical development of novel drug candidates. Dr. Léger is a medicinal chemist with 25 years of biopharmaceutical experience in companies at a variety of stages of growth. Together they bring a broad spectrum of skills and expertise that span the drug development process,” said Richard Andrews, MS, President and CEO of Azitra.

“Their expertise in microbiology, formulation and the biological products will, in particular,help grow the Azitra pipeline as we harness the body’s safe, commensal skin bacteria to promote skin immunity, repair and antimicrobial defense,”Mr. Andrews added.

Dr. Grossman joins Azitra from Melinta Therapeutics, where she was Senior Director of Biology and Pharmacology. Previously, she held leadership positions at TetraPhase Pharmaceuticals and Vertex Pharmaceuticals. Dr. Grossman began her career at Procept, Inc., where she managed a fermentation laboratory and developed new recombinant protein production strategies in prokaryotic and eukaryotic systems. She earned her undergraduate degree in Biology from the State University of New York at Albany and her master’s and Ph.D.degrees in Biology and Molecular Genetics from Albert Einstein College of Medicine.

Prior to joining Azitra, Dr. Léger was Senior Director Chemistry and CMC at Thrasos Therapeutics, where he oversaw discovery research operations as well as manufacturing and clinical supply. He also previously served as VP Research at Indel Therapeutics Inc. and as VP R&D Chemistry and Co-founder at Ulysses Pharmaceuticals, as well as Director of Medicinal Chemistry at ConjuChem Inc., where he led discovery chemistry in protein therapeutics to treat multiple ailments including diabetes, obesity, cancer and infectious diseases. Dr. Léger earned his undergraduate and graduate degrees from the University of Montreal and served as a postdoctoral fellow at the University of Geneva Switzerland and at Columbia University.

Vedanta Biosciences Closes Extended $45.5 Million Series C Financing
Vedanta Biosciences, a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, announced on 5/13/19 that it has raised an additional $18.5 million as an extension of its Series C financing, bringing the total for the round to $45.5 million. The new investment comes from JSR Corporation, Shumway Capital, SymBiosis LLC, and Partners Investment Co., Ltd., who join previously disclosed investors the Bill & Melinda Gates Foundation, Bristol-Myers Squibb, Rock Springs Capital, Invesco Asset Management, Health for Life (Seventure Partners), and founder PureTech Health. Proceeds from the financing will be used to advance Vedanta’s clinical portfolio including a Phase 1/2 study of VE416 in food allergy, a Phase 1b/2 study of VE800 and OPDIVO® (nivolumab) in advanced or metastatic cancers, and the ongoing Phase 2 study of VE303 in recurrent Clostridium difficile infection (rCDI). A Phase 1 clinical study of VE202 in healthy volunteers is being advanced with Janssen as part of an ongoing collaboration in inflammatory bowel disease (IBD).

 “Our platform has the potential to address broad medical needs, including the treatment of drug resistant infection, food allergies, and other immune-mediated conditions where current approaches fall short,” said Bernat Olle, PhD, co-founder and chief executive officer of Vedanta Biosciences. “This financing will enable us to continue to advance defined bacterial consortia as a new modality, including generating clinical readouts in multiple therapeutic areas, and we are grateful to our new and existing investors for their support.”

 Vedanta Biosciences is developing consortia of bacterial strains designed to effect robust and durable therapeutic changes in a patient's gut microbiota. In contrast to fecal transplants or administration of fecal fractions, Vedanta Biosciences' consortia are defined compositions of bacteria manufactured from pure, clonal cell banks, without the need to rely on direct sourcing of fecal donor material of inconsistent composition.

FDA and Infant Bacterial Therapeutics agree on the design of Phase III study
For an extended time, IBT has consulted with the US Food and Drug Administration (FDA) on how the company’s planned Phase III study should be designed. IBT announced on 5/19/19 that the FDA has now informed IBT in writing that IBT has responded satisfactorily to the comments that the FDA had regarding the study design and that there are currently no additions from the FDA’s side. As a consequence of the FDA’s comments, an evaluation of the effects of IBP-9414 on the digestive system of premature infants in the forthcoming Phase III study is now planned, as a serious medical problem for premature infants is that they cannot take up nourishment in an adequate way.
As previously announced, IBT has discussed the clinical development plan PIP (pediatric investigation plan) with the EMA (European Medicines Agency), which resulted in IBT’s PIP being approved in 2017.
IBT hopes to receive the formal clinical trials approval before the end of the first half of the year. As previously announced, IBT plans to start the study in hospitals in France, Hungary, Israel, Spain, the United Kingdom, and the United States.
“Receiving the FDA’s comments took longer than we expected, but now we have a greatly improved protocol compared to what we had 6 months ago. Previously, our only focus was on preventing NEC (necrotizing enterocolitis), that in itself is a terrible intestinal disease which impacts premature infants and too often leads to fatal outcomes. During the spring of 2019, through consultation with the FDA, we have broadened the disease indications on which our drug candidate can hopefully demonstrate an effect,” says CEO Staffan Strömberg.

SkinBioTherapeutics shortlisted for Best Technology at European Mediscience Awards 2019
SkinBioTherapeutics plc (AIM: SBTX or the “Company”), a life sciences company focused on skin health, announced on 5/16/19 that it has been shortlisted for Best Technology at the European Mediscience Awards 2019.
Now in its 18th year, the European Mediscience Awards recognises the successes and achievements of private and publicly quoted healthcare, biotech and life science companies from across Europe. Over 500 European companies and their corporate advisors, analysts, fund managers, commentators and peers will be in attendance at the awards dinner.
The award category is for a technology that, in the eyes of the Voting Panel, is innovative, well funded, and capable of significant commercial success. The technology concerned could have been developed within the organisation or acquired.

SkinBioTherapeutics has been nominated for its proprietary platform technology, SkinBiotix®, which is based on discoveries made by Professor Cath O’Neill and Professor Andrew McBain at the University of Manchester.
The SkinBiotix® platform, which applies lysates derived from probiotic bacteria, has been shown to improve the barrier effect of skin models, protect skin models from infection and repair skin models. Recent independent human study data demonstrated that SkinBiotix® is safe, well tolerated and has efficacy in certain age groups when applied to healthy skin.
Professor Cath O’Neill, CEO of SkinBioTherapeutics, said,
“We are delighted to have been shortlisted for Best Technology at this year’s European Mediscience Awards. Regardless of the result, for SkinBiotix® to be recognised among so many other fantastic technologies is a proud moment. This follows on the recent positive human study data which validated the technology. We are all looking forward to the awards night on 13 June and wish luck to all the other nominees.”

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