Microbiome Report

September 11, 2019

Azitra, Inc.Appoints Mark Sampson, Ph.D. as Chief Scientific Officer
On 8/27/19, Azitra, Inc., a clinical-stage medical dermatology company addressing severe skin conditions by harnessing the microbiome, announced the appointment of Mark Sampson, Ph.D. as Chief Scientific Officer.Travis Whitfill, Co-founderof Azitra, will serve as Executive Director of Advanced Technology, and will Chair Azitra’s Scientific Advisory Board.

“Markbrings insight, experience and focused leadership to our programsand will play an instrumental role in bringing Azitra to the next level. We havemade tremendous progress this year, and with Mark leading our technical team Iam confident we will enjoy moregrowth and success,” said Richard Andrews, MS, President and CEO of Azitra. “Weare grateful to Travis for his creative leadership since the founding of Azitra. He recognizedthe potential of the microbiome as a powerful tool for improving skin health and appearanceand built the company’s foundation. His many contributions have brought us to where we are today. With Mark joining,we will nowfully capture the promise of our technology andfocus on critically important needs in medical dermatology.

”Dr. Sampson most recently worked withBotanix Pharmaceuticals where he was responsible for development of the preclinical strategy and clinical development plans for new antimicrobial indications. Previously, he served as Vice President of Research and Development at Realm Therapeutics (formerly Puricore), a company developing therapeutics for dermatology and immune-mediated diseases. Dr. Sampson held prior research roles at Sterilox Technologies and Warwick International Ltd. He earned an undergraduate degree and Ph.D. degree in Microbiology/Biochemistry from University of Aberdeen, UK.

“I am very excited to join Azitra at this important stage of the company’s growth as additional products begin to enter clinical trials,” said Dr. Sampson. “Azitra’sunique approach to leveraging the microbiome to treat adverse skin conditions holds great promise.I look forward to continuing to buildthe teamand advance these programs focused onexciting potential new treatments for serious skin conditions.”

LNC Therapeutics Raises €6.2 Million for the Clinical Development of New Generation Drugs Based on the Gut Microbiome
LNC Therapeutics, a French biotech company specializing in gut microbiome-based drug discovery, announced on 9/6/19 that it has raised €6.2 million via a capital increase and non-dilutive funding.

This new capital increase of €4.9 million involved the Company’s historic shareholders, including Seventure Partners and a new family office.

LNC Therapeutics has also obtained €0.5 million in funding through a grant from the Nouvelle-Aquitaine region, as part of its regional innovation grant policy, as well as €0.8 million from BpiFrance as part of its Deeptech programme. Deeptech was introduced by BpiFrance in January 2019, and aims to support French start-ups developing breakthrough technological innovations capable of meeting actual major challenges. The programme is intended to make France more competitive in all sectors, particularly science-related ones.

“We are delighted to have secured this funding, which shows the confidence that investors have in our unique technology and expertise. We are particularly proud to have been selected by BpiFrance to take part in its Deeptech programme, which acknowledges the technological innovation developed by French companies, such as LNC Therapeutics. We’re also grateful to the Nouvelle-Aquitaine region for its support.” said Georges Rawadi, Chief Executive Officer of LNC Therapeutics.

Live Biotherapeutic Products (LBPs) are a new class of drugs that contain living organisms such as bacteria, and that are being used by LNC Therapeutics to treat diseases with major unmet medical needs. LNC Therapeutics is currently focusing its R&D efforts on the bacteria family Christensenellaceae.

Christensenellais a genus of bacteria that was described for the first time in 2012. It has been the subject of many academic studies that have revealed its benefits for human health, particularly in the treatment of metabolic diseases and inflammatory bowel diseases.

LNC Therapeutics currently has two programmes dedicated to Christensenellaand its human health applications, for which the Company obtained an exclusive license agreement from Cornell University (Ithaca, New York, United States).

  •     The LNC01 programme aims to develop LBPs based on a unique christensenella strain to treat obesity and metabolic diseases.
  • The LNC02 programme is focused on studying christensenella and identifying new therapeutic applications via LNC Therapeutics’ exclusive research platform.

With these newly raised funds, LNC Therapeutics intends to ramp up the LNC01 programme in order to file an IND[1](Investigational New Drug) application and begin first-in-man clinical trials in 2020.

Synlogic Presents Data from Phase 1/2a Study of SYNB1618 at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM)
Synlogic, Inc., (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, announced on 9/4/19 presentation of the full clinical data set from healthy volunteers and patient cohorts of a randomized, double-blind, placebo-controlled Phase 1/2a study of SYNB1618, which is being developed as an oral therapy for the treatment of phenylketonuria (PKU). The data were presented by Jerry Vockley, M.D. Ph.D., Professor of Pediatrics and Chief of Medical Genetics, University of Pittsburgh, on September 4, 2019 at the annual symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) in Rotterdam.

“Lifetime dietary management of PKU is effective but challenging for patients and there remains a significant unmet need for this population,” said Dr. Vockley, who was a principal investigator on Synlogic’s study. “Physicians, patients and families welcome the development of novel therapies like SYNB1618 that have the potential to impact the lives of all PKU patients.”

The study’s primary objectives were to evaluate safety and tolerability of an early liquid formulation of SYNB1618, as well as clearance of SYNB1618 from the gastrointestinal (GI) tract after cessation of dosing. Exploratory outcomes were related to the assessment of the pharmacodynamic effects of SYNB1618, including measurement of previously identified biomarkers related to SYNB1618’s engineered ability to consume phenylalanine (Phe).

“With this study, we have taken another step towards our goal of delivering a safe, oral therapy option for all patients with PKU regardless of age or disease type,” said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. “These important data have informed advancement of SYNB1618 and, more broadly, have demonstrated the potential of our Synthetic Biotic development platform to deliver novel medicines designed to perform a therapeutic function.”

Synlogic’s Synthetic Biotic platform leverages the tools and principles of synthetic biology to engineer a non-pathogenic strain of E. coli (Nissle) to perform or deliver specific functions lost or damaged due to disease. SYNB1618, designed to function in the GI tract, has been engineered with two different mechanisms to consume Phe, an essential amino acid that can accumulate to harmful levels in patients with PKU with severe consequences. SYNB1618 is designed to metabolize Phe to harmless compounds including trans-cinnamic acid (TCA) in the blood which is further metabolized in the liver and excreted as hippurate (HA) in the urine. TCA and HA represent specific quantitative biomarkers of SYNB1618 activity as demonstrated by Synlogic’s preclinical data that were published in Nature Biotechnology and in data from healthy volunteers from the first part of this Phase 1/2a study. SYNB1618 is also designed to metabolize Phe to phenylpyruvate (PP) via a second enzyme mechanism, L-amino acid transaminase (LAAD). One of the downstream metabolites of LAAD activity is phenyl-lactic acid (PLA) which can be measured in the urine.

In summary:

    A statistically significant increase in biomarkers of SYNB1618 activity (TCA and HA) was observed in both healthy volunteers and PKU patients treated with SYNB1618, but not in subjects treated with placebo, indicating that SYNB1618 was able to carry out its designed function and consume Phe in the human GI tract.
    Equivalent biomarker production and tolerability were observed in both patients and healthy volunteers at a dose of 7 x 1010 colony forming units (CFU) supporting the evaluation of a solid oral formulation of SYNB1618 in a bridging study in healthy volunteers to inform dosing in a subsequent efficacy study in patients.
    Evidence of activity in the human GI tract of the second Phe-consuming function engineered into SYNB1618 (LAAD) was provided by data from healthy volunteers.
    There were no treatment-related serious adverse events (SAEs), treatment-emergent AEs were either mild or moderate in severity. Most were GI-related, mild and reversible.
    All subjects cleared the bacteria in the expected time frame. There was no evidence of colonization, and no subject required antibiotics.
    Blood Phe levels were measured in all PKU patients over the course of the study. However, the study was not designed or powered to demonstrate Phe lowering.

In addition to the presentation highlighting results of the Phase 1/2a study of SYNB1618, Synlogic presented a poster describing a mathematical model for the relationship of blood Phe lowering with decreasing Phe levels in the GI tract as a result of reduced dietary Phe intake. The model can be used to estimate the potential effects of Phe consumption by SYNB1618 on blood Phe lowering in PKU patients.

SYNB1618 Clinical Development Plans and Upcoming Milestones
Synlogic has developed a robust and reproducible process and manufactured a new solid formulation of SYNB1618 that maintains strain viability and activity. Synlogic is currently evaluating this new formulation in an ongoing bridging study in healthy volunteers. A solid oral formulation of SYNB1618 with improved quality attributes may enable dosing to higher activity in a larger out-patient efficacy study in patients. Synlogic expects to initiate the SYNB1618 efficacy study in the first half of 2020.

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