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
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® (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 centers in the
United States, will evaluate the safety and tolerability and
clinical activity of VE800 in combination with Opdivo®, as measured
by the confirmed overall response rate, in addition to other
parameters. The open-label, non-randomized study will target
enrollment 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®. 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, Ph.D., 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 tumors 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 tumors,
thereby promoting suppression of tumor 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-tumor
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, M.D.,
Ph.D., of Keio University School of Medicine. The research also
showed that mice colonized with VE800 demonstrated enhanced
therapeutic efficacy in a range of tumor 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, M.D., 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, M.D., Ph.D.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, M.D., Ph.D. 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, M.D. 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, M.Sc. 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, M.D., Ph.D. is recognized 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, M.D., Ph.D. 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, Ph.D. 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
standardized 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 tumors, thereby
promoting suppression of tumor 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 optimization, 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®), 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.
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® is a registered trademark of Bristol-Myers Squibb
Company.
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version on businesswire.com: https://www.businesswire.com/news/home/20191209005828/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com
US media Tom Donovan +1 857 559 3397
tom@tenbridgecommunications.com
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