Company also completes first-ever
CGMP-compliant manufacturing of a rationally-defined bacterial
consortia in powder form
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 fecal material or spore fractions of fecal
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.
Forward Looking Statement
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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.
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PureTech HealthAllison Mead Talbot, +1
617-651-3156amt@puretechhealth.com
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