TIDMPRTC
PureTech Health PLC
10 December 2019
10 December 2019
PureTech Health plc
PureTech Affiliate Vedanta Biosciences Announces Initiation of
First-in-Patient Study of Immuno-Oncology Candidate VE800 In
Combination with Bristol-Myers Squibb's Opdivo(R) (Nivolumab)
First clinical study of a rationally-defined bacterial
consortium (VE800) for the treatment of cancer
Vedanta forms Immuno-Oncology Scientific Advisory Board of
industry experts to support the clinical development of VE800
PureTech Health plc (LSE: PRTC) ("PureTech"), a clinical stage
biotechnology company dedicated to discovering, developing and
commercialising highly-differentiated medicines for devastating
diseases, is pleased to announce that its affiliate, Vedanta
Biosciences, has initiated a first-in-patient clinical study of its
immuno-oncology candidate, VE800, in patients with select types of
advanced or metastatic cancer.
This open-label, non-randomised study will evaluate the safety,
tolerability and clinical activity of VE800 in combination with
Bristol-Myers Squibb's programmed death-1 (PD-1) immune checkpoint
inhibitor Opdivo(R) (nivolumab). Vedanta will target enrolment of
over 100 patients in the United States diagnosed with advanced or
metastatic melanoma, gastric/gastroesophageal junction
adenocarcinoma or microsatellite-stable colorectal cancer.
Bharatt Chowrira, JD, PhD, president and chief of business and
strategy at PureTech, said: "This study marks the beginning of
Vedanta's fourth clinical programme and its first in clinical
immuno-oncology. In preclinical work, VE800 was observed to enhance
the ability of T cells to infiltrate tumours, promoting suppression
of tumour growth and suggesting enhanced survival. This is why we
believe it has the potential to substantially improve outcomes for
patients with advanced or metastatic cancers. We are pleased with
the progress of Vedanta's diversified clinical stage pipeline and
their leadership in the development of live biotherapeutic products
based on the human microbiome."
Vedanta also announced the formation of an Immuno-Oncology
Scientific Advisory Board, comprised of experts in immunology,
immuno-oncology and the microbiome, which will support the planned
clinical development of VE800.
The full text of the announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Announces Initiation of First-in-Patient
Study of Immuno-Oncology Candidate VE800 In Combination with
Bristol-Myers Squibb's Opdivo(R) (Nivolumab)
First clinical study of a rationally-defined bacterial
consortium (VE800) for the treatment of cancer
Company forms Immuno-Oncology Scientific Advisory Board of
industry experts to support the clinical development of VE800
CAMBRIDGE, Mass., Dec. 10, 2019-Vedanta Biosciences, Inc.
(Vedanta Biosciences, Vedanta or the Company), a clinical-stage
biopharmaceutical company developing a new category of therapies
for immune-mediated diseases based on defined bacterial consortia,
today announced the initiation of a first-in-patient clinical study
of VE800 in combination with Bristol-Myers Squibb's programmed
death-1 (PD-1) immune checkpoint inhibitor Opdivo(R) (nivolumab) in
patients with select types of advanced or metastatic cancer.
Vedanta also announced the formation of its Immuno-Oncology
Scientific Advisory Board (SAB), which is comprised of experts in
immunology, immuno-oncology and the microbiome, to support the
planned clinical development of VE800.
The study, which is being conducted at clinical centres in the
United States, will evaluate the safety and tolerability and
clinical activity of VE800 in combination with Opdivo(R), as
measured by the confirmed overall response rate, in addition to
other parameters. The open-label, non-randomised study will target
enrolment of over 100 patients diagnosed with advanced or
metastatic melanoma, gastric/gastroesophageal junction
adenocarcinoma, or microsatellite-stable colorectal cancer.
Eligible patients will receive daily VE800 dosing in combination
with Opdivo(R). Topline results are anticipated in 2021.
"Despite unprecedented global investment in checkpoint
inhibitors, there is still a major need for differentiated
approaches to further enhance and expand responses in cancer," said
Bernat Olle, PhD, co-founder and chief executive officer of Vedanta
Biosciences. "The role the gut microbiota plays in influencing
responses to immunotherapies has been ignored by previous
approaches, so we are excited about the potential of microbiome
modulation to open up an entirely new approach to cancer
therapy."
VE800 is made up of 11 commensal bacterial strains that act in
concert to activate cytotoxic CD8+ T cells, which are the vanguard
of the immune system's response to tumours and thus a key driver of
effective immunotherapies. 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
potentially enhancing survival. Preclinical data also suggest that
VE800 may enhance the effects of checkpoint inhibitors.
Foundational work demonstrating VE800's novel anti-tumour
activity and cooperatively potentiated responses to checkpoint
inhibitor therapies and various immune challenges was published in
Nature by Vedanta and its scientific co-founder Kenya Honda, MD,
PhD, of Keio University School of Medicine. The research also
showed that mice colonised with VE800 demonstrated enhanced
therapeutic efficacy in a range of tumour models when VE800 was
administered in conjunction with PD-1 or CTLA4 immune checkpoint
inhibitors.
"The ability of bacterial consortia to mediate immune activity,
including potential anti-cancer activity, is an exciting area for
investigation in indications with some of the highest unmet medical
need," said Hassane M. Zarour, MD, co-leader of the Cancer
Immunology and Immunotherapy Program of the Hillman Cancer Center,
University of Pittsburgh, and a member of Vedanta's newly formed
Immuno-Oncology SAB. "We see enormous potential for this class of
drugs to improve cancer patients' outcomes."
Vedanta's newly announced Immuno-Oncology SAB will work closely
with the Company's scientific co-founders and leadership to further
support the clinical development of VE800. The SAB includes:
-- Antoni Ribas, MD, PhD is a leading translational and clinical
researcher in immuno-oncology with a focus on malignant melanoma.
He is a professor of medicine, surgery and molecular and medical
pharmacology at the University of California Los Angeles (UCLA),
director of the tumor immunology program at the Jonsson
Comprehensive Cancer Center, director of the Parker Institute for
Cancer Immunotherapy Center at UCLA, chair of the Melanoma
Committee at SWOG and president-elect 2019-2020 of the American
Association for Cancer Research (AACR).
-- Josep Tabernero, MD, PhD is a researcher focused on
gastrointestinal cancers and cancer genetics. At Vall D'Hebron
Institute of Oncology (VHIO), he is director of clinical research,
co-director of the research unit for molecular therapy of cancer,
head of the gastrointestinal and endocrine tumors group, and head
of the medical oncology department of Vall d'Hebron University
Hospital. He is also president of the European Society for Medical
Oncology (ESMO).
-- Hassane Zarour, MD is a researcher with expertise in melanoma
and skin lesions, immunotherapy and cancer vaccines. At the
University of Pittsburgh Medical Center, he is a professor of
medicine, immunology and dermatology, co-leader of the melanoma
program and the James W. and Frances G. McGlothlin chair in
melanoma immunotherapy research.
-- Diwakar Davar, MBBS, MSc is a leader in microbiome science
and using the microbiome to treat melanoma. He is an assistant
professor of medicine at the University of Pittsburgh Medical
Center.
-- Bertrand Routy, MD, PhD is recognised as one of the first
researchers to demonstrate the negative impact of antibiotics and
the microbiome on the efficacy of checkpoint inhibitor therapy. He
is an assistant professor of hematology-oncology and director of
the laboratory of immunotherapy / oncomicrobiome at the Centre
hospitalier de l'Université de Montréal (CHUM).
-- Dan Littman, MD, PhD is a scientific co-founder of Vedanta
and a leader in T cell biology, including differentiation and
lineage specification. He is the Helen L. and Martin S. Kimmel
professor of molecular immunology and pathology and professor in
the department of microbiology at the Skirball Institute of
Biomolecular Medicine at New York University Langone School of
Medicine.
-- Sasha Rudensky, PhD is a scientific co-founder of Vedanta and
a leader in molecular mechanisms of CD4 T cell differentiation,
particularly regulatory T cells. He is chair of the immunology
program at Sloan Kettering Institute (SKI) and director of the
Ludwig Center at Memorial Sloan Kettering (MSK).
About VE800
VE800 is Vedanta Biosciences' proprietary, orally administered
immuno-oncology product candidate. It is produced from pure,
non-pathogenic clonal bacterial cell banks, which yield a
standardised drug product in powdered form. VE800 consists of a
rationally-defined bacterial consortium of 11 commensal strains
that, acting in concert, activate 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.
Preclinical data also suggest that VE800 may enhance the effects of
checkpoint inhibitors. Vedanta is evaluating VE800 as a potential
treatment for patients with advanced or metastatic cancers.
About Vedanta Biosciences
Vedanta Biosciences is a clinical-stage microbiome leader
developing a new category of therapies for immune-mediated diseases
based on rationally-defined consortia of human microbiome-derived
non-pathogenic bacteria. Vedanta's proprietary capabilities include
what is believed to be the largest collection of human-gut
associated bacteria, assays and bioinformatics techniques for
consortia design and optimisation, vast 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 (2013,
2019), Cell, and Nature Immunology. Vedanta Biosciences has
harnessed these biological insights and its capabilities to
generate a pipeline of investigational live biotherapeutic products
(LBPs) in infectious disease, autoimmune disease, allergy, and
immuno-oncology. This pipeline includes four clinical-stage product
candidates currently being evaluated for the treatment of recurrent
C. difficile infection, inflammatory bowel disease (in
collaboration with Janssen Biotech, Inc.), food allergy and
advanced or metastatic cancers (in combination with Bristol-Myers
Squibb's checkpoint inhibitor Opdivo(R)), respectively.
Vedanta's IP portfolio contains over 30 issued patents with
coverage through at least 2031. 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.
About PureTech Health
PureTech is a clinical stage biotechnology company dedicated to
discovering, developing and commercialising highly differentiated
medicines for devastating diseases, including intractable cancers,
lymphatic and gastrointestinal diseases, central nervous system
disorders, and inflammatory and immunological diseases, among
others. The Company has created a broad and deep pipeline through
the expertise of its experienced research and development team and
its extensive network of scientists, clinicians and industry
leaders. This pipeline, which is being advanced both internally and
through PureTech's affiliates, is comprised of 24 product
candidates and one product that has been cleared by the US Food and
Drug Administration (FDA). All of the underlying programmes and
platforms that resulted in this pipeline of product candidates were
initially identified or discovered and then advanced by the
PureTech team through key validation points based on the Company's
unique insights into the biology of the brain, immune, and gut, or
BIG, systems and the interface between those systems, referred to
as the BIG Axis.
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.
Opdivo(R) is a registered trademark of Bristol-Myers Squibb
Company.
Contact:
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END
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