TIDMPRTC
PureTech Health PLC
09 June 2020
9 June 2020
PureTech Health plc
PureTech Founded Entity Vedanta Biosciences Announces Positive
Topline Data from Two Phase 1 Studies for IBD Candidate VE202
VE202 was generally safe and well-tolerated in healthy
volunteers, with durable and dose-dependent colonisation that will
inform the Phase 2 dose regimen
Vedanta has regained full rights to the programme and plans to
advance it in a Phase 2 study within the next 12 months
Company strengthens balance sheet with an additional $12 million
in new equity and R&D collaboration funds, bringing the total
Series C round to $71.1 million
PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a
clinical-stage biotherapeutics company dedicated to discovering,
developing and commercialising highly differentiated medicines for
devastating diseases, is pleased to note that its Founded Entity,
Vedanta Biosciences, today announced positive topline data from two
Phase 1 studies in healthy volunteers of VE202, the company's
orally-administered live biotherapeutic product (LBP) candidate for
inflammatory bowel disease (IBD). The studies showed that VE202 was
generally safe and well-tolerated at all doses and demonstrated
durable and dose-dependent colonisation. Vedanta expects to begin a
Phase 2 study in IBD patients in the next 12 months. The trial was
conducted by Janssen Research & Development, LLC; a more
complete study dataset and analyses will be submitted to a
peer-reviewed journal. Vedanta has regained full rights to the IBD
programme and will owe Janssen single-digit royalty payments on net
sales of a commercialised product.
Vedanta also announced the receipt of $12 million in additional
capital and R&D collaboration funds from new and existing
investors, including JSR Corporation, bringing the total Series
C/C-2 funding to $71.1 million. Participants in the total Series C
round included the Bill & Melinda Gates Foundation, Bristol
Myers Squibb, Rock Springs Capital, JSR Corporation, Shumway
Capital, Health for Life (Seventure Partners), QUAD Investment
Management, SV Investment Corp., Shinhan Investment-Private Equity,
Shinhan Capital-Yeollim Partners, Partners Investment Co., Ltd, FC
Capital, SymBiosis LLC, and founder PureTech.
Bharatt Chowira, JD, PhD, PureTech's president and chief of
business and strategy, said: "Vedanta has built an impressive body
of evidence that its live biotherapeutic product candidates are
safe, well-tolerated and able to modulate the human microbiome in a
highly targeted and durable fashion, opening the door for an
exciting and entirely novel class of therapeutics. These trial
results and the additional Series C funding from leading investors
are important milestones for Vedanta and we look forward to the
launch of the Phase 2 trial in IBD patients and other advances
across the breadth of Vedanta's pipeline of compelling
programmes."
The full text of the announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Announces Positive Topline Data from Two
Phase 1 Studies of VE202, a Rationally Defined Bacterial Consortium
Being Advanced for Inflammatory Bowel Diseases (IBD)
VE202 was generally safe and well-tolerated in healthy
volunteers, with durable and dose-dependent colonisation that will
inform the Phase 2 dose regimen
Vedanta has regained full rights to the programme and plans to
advance it in a Phase 2 study within the next 12 months
Company also announces the issuance of three European patents
including coverage of consortium compositions containing
Clostridium bacterial strains for IBD
Company strengthens balance sheet with an additional $12 million
in new equity and R&D collaboration funds, bringing the total
Series C round to $71.1 million
CAMBRIDGE, Mass., June 9, 2020 - 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 positive topline
data from two Phase 1 studies in healthy volunteers of VE202, the
company's orally-administered live biotherapeutic product (LBP)
candidate for inflammatory bowel disease (IBD). The studies showed
that VE202 was generally safe and well tolerated at all doses and
demonstrated durable and dose-dependent colonisation. Vedanta
expects to begin a Phase 2 study in IBD patients in the next 12
months. Vedanta also announced the receipt of $12 million in
additional capital and R&D collaboration funds from new and
existing investors, including JSR Corporation, bringing the total
Series C/C-2 funding to $71.1 million. Vedanta's pipeline includes
four clinical-stage product candidates currently being evaluated
for the treatment of high-risk C. difficile infection, IBD, food
allergy and advanced or metastatic cancers (in combination with
Bristol Myers Squibb's checkpoint inhibitor Opdivo(R)).
"We have now seen across three Phase 1 studies for VE202 and
VE303, which collectively recruited 143 volunteers, that our LBPs
appear to be safe and have the intended effect of robustly and
durably colonising and changing the gut microbiome composition in a
targeted manner," said Bernat Olle, PhD, chief executive officer of
Vedanta Biosciences. "Current treatments for IBD block mediators of
inflammation, but do not address the underlying alterations in the
gut microbiota that may be driving the inflammation in the first
place. There is significant evidence of the role of the microbiome
in IBD, which underscores the need for safe approaches that address
this aspect of the disease."
The Phase 1 studies of VE202 enrolled 105 healthy volunteers in
single and multi-dose cohorts, and evaluated two variants of VE202,
with either 11 or 16 bacterial strains forming the consortia. These
consortia include several species of bacteria belonging to
Clostridium Clusters IV and XIVa, which have been previously shown
to play a role in induction of tolerance in IBD and are associated
with disease remission. Preliminary data include:
-- Both single and multiple doses of the 11- and 16-strain
consortia were generally safe and well-tolerated. There were no
serious adverse events related to VE202.
-- Both consortia variants colonised the gut abundantly.
Colonisation was most effective with vancomycin pre-treatment
followed by multiple doses of the consortia. In subjects who were
dosed for 14 days, VE202 strains were detected at high abundances
12 weeks after dosing ended, suggesting substantial durability of
colonisation.
The trial was conducted by Janssen Research & Development,
LLC; a more complete study dataset and analyses will be submitted
to a peer-reviewed journal.
Vedanta has regained full rights to the programme and will owe
Janssen single-digit royalty payments on net sales of a
commercialised product. Vedanta plans to take the programme forward
into Phase 2 studies over the next 12 months.
Additionally, the European Patent Office (EPO) recently granted
Vedanta Biosciences three patents in its foundational intellectual
property (IP) family covering the use of bacterial consortia of
clostridium species in autoimmune diseases, including IBD. The
patent issuances follow the 2019 decision of the Opposition
Division of the EPO to uphold Vedanta's foundational patent
EP2575835 (the "Honda patent"), strengthening Vedanta's IP position
in the area of live bacterial therapeutics.
About VE202
VE202 is a first-in-class orally-administered investigational
live biotherapeutic product (LBP) consisting of a defined bacterial
consortium. It is produced under GMP conditions from pure, clonal
bacterial cell banks, which yield a standardised drug product in
powdered form and bypasses the need to rely on direct sourcing of
faecal donor material of inconsistent composition. VE202 was
designed to induce immune tolerance via the gut and thereby
potentially treat inflammatory bowel disease. Results describing
the biology and candidate selection of
VE202 were previously published in Science and Nature ( multiple ).
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
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 (
multiple ), 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 high-risk
C. difficile infection, inflammatory bowel disease, food allergy
and advanced or metastatic cancers (in combination with Bristol
Myers Squibb's checkpoint inhibitor Opdivo(R)).
Vedanta's IP portfolio contains over 40 patents with coverage
through at least 2038. Vedanta Biosciences was founded by PureTech
(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 biotherapeutics 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 Founded Entities,
is comprised of 23 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.
Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Stephanie Simon
+1 617 651 3156 +44 (0) 20 3727 1000 +1 617 581 9333
amt@puretechhealth.com ben.atwell@FTIconsulting.com stephanie@tenbridgecommunications.com
Opdivo (R) is a registered trademark of Bristol Myers Squibb Company.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRADGGDLCDGDGGI
(END) Dow Jones Newswires
June 09, 2020 02:00 ET (06:00 GMT)
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jul 2023 to Jul 2024