TIDMPRTC
PureTech Health PLC
23 January 2019
23 January 2019
PureTech Health plc
PureTech's Vedanta Biosciences Publishes Seminal Research in
Leading Scientific Journal for its Immuno-oncology Candidate,
VE800
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) Axis, is pleased to note
that its affiliate Vedanta Biosciences today announced the
publication of important research in one of the top scientific
journals, Nature, that underlies Vedanta's proprietary oral
immuno-oncology product candidate, VE800. The research revealed a
new mechanism by which human microbiota induce an important immune
cell that is key to the body's ability to generate antitumor
immunity. It also identified a proprietary consortium of bacterial
strains that harnesses this mechanism, VE800, which Vedanta
Biosciences expects to enter the clinic in 2019 in combination with
Bristol-Myers Squibb's checkpoint inhibitor OPDIVO(R)
(nivolumab).
Bharatt Chowrira, JD, PhD, President and Chief of Business and
Strategy at PureTech Health, said: "This Nature publication reveals
- for the first time - that human microbiome-derived bacterial
consortia have the potential to enhance and broaden the responses
to immune checkpoint inhibitors. The research also led to the
selection of VE800, which we believe has tremendous therapeutic
potential to treat a broad range of cancers. We look forward to
Vedanta's clinical trials of VE800 in combination with
Bristol-Myers Squibb's Opdivo (nivolumab), which are planned for
2019."
The full text announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Announces Publication in Nature of Seminal
Research Revealing A New Mechanism of Human Microbiota-Driven
Antitumor Immunity Involving Induction of IFNy+ CD8+ T Cell
Accumulation in the Gut and Tumours
Research also identified a rationally-defined consortium of
human commensal bacteria (VE800) that robustly induces IFNy+ CD8+ T
cells and enhances antitumor immunity
Vedanta's clinical candidate VE800 is expected to enter clinical
studies in 2019 in combination with Bristol-Myers Squibb's
checkpoint inhibitor OPDIVO(R) (nivolumab)
CAMBRIDGE, Mass., Jan. 23, 2019-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, today announced a publication in
Nature that revealed a newly discovered mechanism underlying
antitumor immunity that involves human microbiota-driven induction
of interferon-gamma-producing (IFNy+) CD8+ T cell accumulation in
the gut and tumours. Led by Vedanta's scientific co-founder Kenya
Honda, MD, PhD, of Keio University School of Medicine, the research
also led to the identification and selection of a defined
consortium of human microbiome-derived bacterial strains that
harnesses this mechanism of antitumor activity and cooperatively
potentiates responses to checkpoint inhibitor therapies and immune
challenges in general. Based on this research, Vedanta is advancing
VE800, a proprietary clinical candidate designed to enhance immune
responses against cancer. Vedanta plans to initiate clinical
studies in 2019 to evaluate VE800 in combination with Bristol-Myers
Squibb's checkpoint inhibitor OPDIVO(R) (nivolumab).
"This research demonstrates that specific, human
microbiome-derived bacteria assembled rationally into consortia can
cooperatively enhance the responses to immune checkpoint
inhibitors, which supports our hypothesis that modulating the gut
microbiota could be a powerful tool for potentiating immune
responses that help fight cancer and infection," said Bernat Olle,
PhD, Chief Executive Officer of Vedanta Biosciences. "This work
also builds upon Dr Honda's previous groundbreaking research on the
role of the human microbiome in modulating a range of immune
responses and provides a robust scientific foundation for our
proprietary lead cancer candidate, VE800."
The authors of the Nature paper sought to understand the
previously poorly-characterised relationship between the human
microbiota and intestinal IFNy+ CD8 T cells, which are critical to
innate and adaptive immune responses. In preclinical models, they
were able to establish that the number and frequency of these
immune cells in the gut depend on the presence of a gut microbiota
and are plastic, with specific members of the microbiota promoting
their intestinal accumulation in an inducible and reversible
manner. The authors went on to identify specific commensal
bacterial strains from healthy human donors that spurred the
production of IFNy+ CD8+ T cells.
Through rigorous selection, the authors isolated a defined
consortium of commensal bacteria derived from the human microbiome
that proved most effective at inducing rapid and persistent
accumulation of IFNy+ CD8+ T cells. Mice colonised with the defined
bacterial consortium demonstrated enhanced therapeutic efficacy in
a range of tumour models when given in conjunction with PD-1 or
CTLA4 immune checkpoint inhibitors. The strains identified are
primarily rare, low-abundance components of the human microbiome,
representing a significant opportunity for amplification as a
therapeutic strategy.
The research demonstrates for the first time that human
microbiome-derived bacterial consortia that cooperatively enhance
the responses of immune checkpoint inhibitors can be identified.
The authors addressed the challenge of reducing a complex community
of human microbiome bacteria down to a few, rationally-defined
members that can induce a robust immune potentiation response
necessary for an effective cancer immune therapy, and directly
linking their activity to pathways that promote antitumor
immunity.
The Nature paper also found that human stool samples showed
considerable variability in their ability to induce colonic IFNy+
CD8+ T cells. Vedanta's development process is designed to bypass
this variability by using pure, clonal cell banks of
well-characterised bacterial strains isolated from healthy humans
to produce defined consortia of uniform composition. This
eliminates the need to rely on direct sourcing of faecal donor
material of inconsistent composition. Vedanta sources bacteria from
a vast, extensively characterised collection of 80,000 bacterial
isolates obtained from human donors from four continents, which is
believed to be the largest collection of human-gut associated
bacteria. It then designs high-throughput assays to screen product
candidates against a given disease target.
About VE800
VE800 is Vedanta Biosciences' proprietary oral immuno-oncology
product candidate. It consists of a rationally-defined bacterial
consortium that activates cytotoxic CD8+ T cells, a type of white
blood cell that is the predominant effector in cancer
immunotherapy. In preclinical studies, VE800 has been shown to
enhance the ability of these T cells to infiltrate tumours, thereby
promoting suppression of tumour growth and enhancing survival. Data
also suggest that VE800 may enhance the effects of checkpoint
inhibitors. Vedanta is evaluating VE800 alone and in combination
with checkpoint inhibitors as a potential treatment for patients
with advanced or metastatic cancers. In December 2018, Vedanta
entered into a clinical trial collaboration to evaluate
Bristol-Myers Squibb's programmed death-1 (PD-1) immune checkpoint
inhibitor OPDIVO (nivolumab) in combination with Vedanta's VE800,
in patients with advanced or metastatic cancers. Clinical trials
are expected to begin in 2019.
About Vedanta Biosciences
Vedanta Biosciences is a clinical-stage company developing a new
category of therapies for immune-mediated diseases based on
rationally-defined consortia of human microbiome-derived bacteria.
Vedanta Biosciences is a leader in the microbiome field with
capabilities and deep expertise to discover, develop, and
manufacture live bacteria drugs. These include what is believed to
be the largest collection of human-gut associated bacteria, a suite
of proprietary assays to select pharmacologically potent strains,
vast proprietary datasets from human interventional studies, and
facilities for cGMP-compliant manufacturing of rationally-defined
bacterial consortia in powder form. Vedanta Biosciences' pioneering
work, in collaboration with its scientific co-founders, 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. These advances have
been published in leading peer-reviewed journals, including Science
(multiple), Nature (multiple), Cell, and Nature Immunology. Vedanta
Biosciences has harnessed these biological insights and its
capabilities to generate a pipeline of programs in infectious
disease, autoimmune disease, allergy, and immuno-oncology.
Vedanta Biosciences was founded by PureTech Health (LSE.PRTC).
Its scientific co-founders are world-renowned experts in immunology
and microbiology who have pioneered the fields of innate immunity,
Th17 and regulatory T cell biology, and include Ruslan Medzhitov,
PhD, (Yale and Howard Hughes Medical Institute (HHMI)), Brett
Finlay, PhD, (University of British Columbia and HHMI), Kenya
Honda, PhD, (inventor of Vedanta Biosciences' lead product
candidate; Keio University and RIKEN), Dan Littman, PhD, (New York
University and HHMI), Alexander Rudensky, PhD, (Sloan Kettering and
HHMI), and Jeremiah Faith, PhD, (Mount Sinai School of
Medicine).
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing novel medicines for dysfunctions of the
Brain-Immune-Gut (BIG) Axis. The Company has developed deep
insights into the connection between these systems and the
resulting role in diseases that have proven resistant to
established therapeutic approaches. By harnessing this emerging
field of human biology, PureTech Health is developing new
categories of medicines with the potential to have great impact on
people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies across two divisions: its Affiliates and its Internal
labs. PureTech's Affiliates include seven clinical-stage platforms
with two product candidates that have been filed with the US Food
and Drug Administration (FDA) for review and other novel
pre-clinical programmes. These affiliates are developing
ground-breaking platforms and therapeutic candidates in
collaboration with some of the world's leading experts.
PureTech's Internal research and development is centred on
tissue-selective immunomodulation for the treatment of oncology,
autoimmune, and CNS-related disorders, with a near-term focus on
targeting newly-discovered, foundational immunosuppressive
mechanisms in oncology and novel approaches that harness the
lymphatic infrastructure.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
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