TIDMPRTC
RNS Number : 4618V
PureTech Health PLC
03 November 2017
3 November 2017
PureTech Health plc
PureTech's Vedanta Biosciences Awarded $5.4 Million Grant from
Combating Antibiotic Resistant Bacteria Biopharmaceutical
Accelerator (CARB-X) to Support Development of a Novel Human
Microbiome-Derived Treatment
PureTech Health plc (LSE: PRTC), an advanced, clinical-stage
biopharmaceutical company, is pleased to note that Vedanta
Biosciences, an affiliate of PureTech Health, today announced that
it has been awarded a $5.4 million research grant from CARB-X
(Combating Antibiotic Resistant Bacteria Biopharmaceutical
Accelerator) to support clinical testing of its lead oral product
candidate, VE303, a novel human-microbiome drug candidate to
address serious bacterial infections. Vedanta also announced that
it has completed what is believed to be the first-ever
CGMP-compliant manufacturing (Current Good Manufacturing Practices,
required by the U.S. Food and Drug Administration) of a
rationally-defined live bacterial consortia in powder form.
Bharatt Chowrira, PhD, JD, President and Chief of Business and
Strategy at PureTech Health, said: "We are pleased to be recognized
as the first microbiome-based anti-infective approach supported by
the world's largest public-private partnership devoted to
antibacterial preclinical R&D. With antibiotic resistance
looming as a major threat, it is inspiring to be working on this
new approach for tackling serious infections. We also believe that
this manufacturing milestone is an important step in moving the
enormous promise of the microbiome field into the realm of serious
medicine with a rationally defined product candidate produced from
pure cell banks in a reproducible and consistent manner."
The full text of the announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Awarded Up To $5.4 Million from CARB-X to
Accelerate Development of VE303, a Novel Human Microbiome-Derived
Treatment for Serious Bacterial Infection
Company also completes first-ever CGMP-compliant manufacturing
of a rationally-defined bacterial consortia in powder form
CAMBRIDGE, Massachusetts, November 3, 2017- Vedanta Biosciences,
an affiliate of PureTech Health (LSE: PRTC), pioneering a novel
category of therapies designed to modulate pathways of interaction
between the human microbiome and the host immune system, today
announced that it has been awarded a research grant of up to $5.4
million from CARB-X (Combating Antibiotic Resistant Bacteria
Biopharmaceutical Accelerator), a global public-private partnership
focused on funding the development of promising new antibacterial
products and rapid diagnostics. The funding will be used to support
clinical testing of Vedanta Biosciences' lead oral product
candidate, VE303, a novel human-microbiome drug candidate to
address Clostridium difficile (C. difficile) and potentially other
bacterial infections. VE303 is a rationally-defined live bacterial
consortia administered via an oral capsule and is expected to be
tested in a human clinical trial this quarter. Also in connection
with the VE303 program, Vedanta today announced that it has
achieved a key development milestone in the human microbiome field,
completing what is believed to be the first-ever CGMP-compliant
(Current Good Manufacturing Practices, required by the U.S. Food
and Drug Administration) manufacturing of a rationally-defined live
bacterial consortia in powder form.
"The Vedanta VE303 microbiome-based anti-infective project is an
exciting addition to the CARB-X pipeline. It is CARB-X's first
award announced for a microbiome project and also the first for a
project targeting C. difficile, bringing a novel approach that
could potentially protect patients from bacterial infections and
save lives," said Kevin Outterson, Executive Director of CARB-X,
the world's leading non-profit partnership dedicated to
accelerating the development of antibiotics, diagnostics and other
products to treat deadly infections.
The Centers for Disease Control and Prevention (CDC) considers
C. difficile infections one of the most urgent bacterial threats.
C. difficile infections account for 15,000 deaths each year in the
U.S. alone. Existing interventions for C. difficile infections
include antibiotics, which have an undesirable side effect of
damaging the gut microbiome and leaving patients vulnerable to
re-infection and building resistance to antibiotics.
"First-generation approaches in the microbiome field for
recurrent C. difficile infection (rCDI) have relied on
uncharacterized faecal material or spore fractions of faecal
material, which are inherently inconsistent procedures," said
Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences.
"We believe that VE303 is the first rationally-defined microbiome
drug advanced to the clinic to tackle rCDI. VE303 is produced from
pure cell banks and it consists of a defined consortia of live
bacteria designed to restore colonization resistance against gut
pathogens following recurrence. We are grateful to CARB-X for their
support and look forward to working together to advance this novel
therapy."
Vedanta has also continued to expand its internal,
state-of-the-art CGMP-compliant manufacturing capability with the
addition of a second manufacturing site, dedicated to production,
packaging, and labelling of live bacterial consortia drug product
capsules. Coupled with existing CGMP-compliant drug substance
production capabilities in Cambridge, MA, the addition fully
integrates Vedanta's manufacturing capabilities, a distinct
competitive advantage in the microbiome field.
"Reproducible CGMP-compliant manufacturing of live bacterial
consortia drugs can be a complex activity, and we have worked
successfully through those technical hurdles," said Dan Couto, SVP
of Operations and Manufacturing for Vedanta Biosciences.
"Completion of this technical milestone significantly de-risks the
company's ability to supply timely clinical material for our
pipeline of programs and provides Vedanta a key strategic advantage
in the microbiome field."
Vedanta Biosciences has created one of the leading end-to-end
platforms for development of live bacterial consortia-based
medicines based on the human microbiome. The platform leverages a
vast clinical dataset from interventional studies, what is believed
to be the largest collection of gut-associated bacteria,
high-throughput proprietary pharmacology screening tools,
state-of-the-art facilities for CGMP-compliant manufacturing, and a
leading intellectual property portfolio that includes issued
patents that we believe to be among the earliest foundational
intellectual property in the microbiome field.
About CARB-X
CARB-X is the world's largest public-private partnership devoted
to antibacterial preclinical R&D. Funded by BARDA and Wellcome
Trust, with in-kind support from NIAID, we will spend $455 million
from 2016-2021 to support innovative products moving towards human
clinical trials. CARB-X focuses on high priority drug-resistant
bacteria, especially Gram-negatives. CARB-X is led by Boston
University School of Law. Other partners include the Broad
Institute of Harvard and MIT, MassBio, the California Life Sciences
Institute and RTI International. For more information, please visit
www.carb-x.org and follow us on Twitter @CARB_X.
About Vedanta Biosciences
Vedanta Biosciences is pioneering development of a novel class
of therapies for immune and infectious diseases based on rationally
designed consortia of bacteria derived from the human microbiome,
with clinical trials expected to begin in the second half of 2017.
An affiliate of PureTech Health (PureTech Health plc, PRTC.L),
Vedanta's founding team includes a group of world-renowned experts
in immunology and microbiology. Vedanta Biosciences is a leader in
the microbiome field with capabilities and deep expertise to
discover, develop and manufacture drugs based on live bacterial
consortia. Leveraging its proprietary technology platform and the
expertise of its team of scientific co-founders, Vedanta
Biosciences has isolated and maintains what we believe to be the
largest collection of human microbiome-associated bacterial strains
and has characterized, in collaborations with leading experts, how
the immune system recognizes and responds to these microbes. This
pioneering work has led to the identification of human commensal
bacteria that induce a range of immune responses - including
induction of regulatory T cells, CD8+ T cells, and Th17 cells,
among others - as well as the characterization of novel molecular
mechanisms of microbial-host communication. These advances have
been published in leading peer-reviewed journals including Science,
Nature (multiple), Cell and Nature Immunology. Vedanta Biosciences
has harnessed these biological insights, its proprietary library of
microbiome-derived bacterial strains, as well as data from clinical
translational collaborations, to generate a pipeline of programs
addressing infectious diseases, autoimmune diseases, inflammation
and immune-oncology indications.
Vedanta Biosciences' scientific co-founders have pioneered the
fields of innate immunity, Th17 and regulatory T cell biology, and
include Dr Ruslan Medzhitov (Professor of Immunobiology at Yale),
Dr Alexander Rudensky (tri-institutional Professor at the Memorial
Sloan-Kettering Institute, the Rockefeller University and Cornell
University), Dr Dan Littman (Professor of Molecular Immunology at
NYU), Dr Brett Finlay (Professor at the University of British
Columbia) and Dr Kenya Honda (Professor, School of Medicine, Keio
University). Vedanta is backed by PureTech Health, Seventure,
Invesco Asset Management, and Rock Springs Capital and has
collaborations with leading institutions including Janssen Biotech,
Inc., NYU Langone Medical Center, Stanford University School of
Medicine, Leiden University Medical Center, University of Tokyo,
Keio University, and RIKEN.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is an advanced,
clinical-stage biopharmaceutical company developing novel medicines
targeting serious diseases that result from dysfunctions in the
nervous, immune, and gastrointestinal systems (brain-immune-gut or
the "BIG" axis), which together represent the adaptive human
systems. PureTech Health is at the forefront of understanding and
addressing the biological processes and crosstalk associated with
the BIG axis. By harnessing this emerging field of human biology,
the Company is pioneering new categories of medicine with the
potential to have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies that includes two pivotal stage programmes, multiple
human proof-of-concept studies and a number of early clinical and
pre-clinical programmes. PureTech's rich research and development
pipeline has been advanced in collaboration with some of the
world's leading scientific experts, who along with PureTech's team
of biopharma pioneers, entrepreneurs and seasoned Board, identify,
invent, and clinically de-risk new medicines. With this experienced
team pursuing cutting edge science, PureTech Health is building the
biopharma company of the future focused on improving and extending
the lives of people with serious disease. For more information,
visit www.puretechhealth.com or connect with us on Twitter
@puretechh.
Forward Looking Statement
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
company's future prospects, developments and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health plc. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither the company nor any other party intends to update or revise
these forward-looking statements, whether as a result of new
information, future events or otherwise.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Contact:
PureTech Health FTI Consulting
Allison Mead Talbot Ben Atwell, Rob
+1 617 651 3156 Winder
amt@puretechhealth.com +44 (0) 20 3727
1000
This information is provided by RNS
The company news service from the London Stock Exchange
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