Financing will enable pivotal Phase 3 study of
VE303 for recurrent C. difficile infection, to begin by 3Q 2023
Funds will also support Phase 2 study of VE202
for ulcerative colitis, to begin in 2Q 2023
Syndicate led by new investors AXA IM Alts and
The AMR Action Fund along with existing investors Bill &
Melinda Gates Foundation, Skyviews Life Science, and others
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company, noted today
that its Founded Entity, Vedanta Biosciences, a clinical-stage
company that is developing a potential new category of oral
therapies based on defined bacterial consortia, today announced
that it has raised $106.5 million to support pivotal-stage
development of its lead candidate, VE303, for the prevention of
recurrent Clostridioides difficile infection (CDI), and a Phase 2
study of VE202 for ulcerative colitis, among other development
activities. The VE303 study would be the first pivotal Phase 3
study of a therapeutic candidate based on a defined bacterial
consortium, which Vedanta is pioneering as a next-generation
approach to microbiome therapy.
The investor syndicate was co-led by new investors AXA IM Alts
and The AMR Action Fund, along with existing investors Bill &
Melinda Gates Foundation, Skyviews Life Science, Reimagined
Ventures, Fiscus Ventures, PEAK6, and Atlantic Neptune. New
investors K2 HealthVentures, Korea Investment Partners, Korea
Investment & Securities Asia Ltd. and Korea Investment &
Securities US, Inc., and existing investors including co-founder
PureTech Health, Revelation Partners, QUAD Investment Management,
Seventure Partners, Hambro Perks, and Pfizer Inc. also
participated.
The full text of the announcement from Vedanta is as
follows:
Vedanta Biosciences Announces $106.5 Million
Financing to Advance Pipeline of Defined Bacterial Consortia
Therapies
Financing will enable pivotal Phase 3 study of
VE303 for recurrent C. difficile infection, to begin by 3Q 2023
Funds will also support Phase 2 study of VE202
for ulcerative colitis, to begin in 2Q 2023
Syndicate led by new investors AXA IM Alts and
The AMR Action Fund along with existing investors Bill &
Melinda Gates Foundation, Skyviews Life Science, and others
CAMBRIDGE, MA, April 25, 2023 – Vedanta Biosciences, a
clinical-stage company that is developing a potential new category
of oral therapies based on defined bacterial consortia, today
announced that it has raised $106.5 million to support
pivotal-stage development of its lead candidate, VE303, for the
prevention of recurrent Clostridioides difficile infection (CDI),
and a Phase 2 study of VE202 for ulcerative colitis, among other
development activities. The VE303 study would be the first pivotal
Phase 3 study of a therapeutic candidate based on a defined
bacterial consortium, which Vedanta is pioneering as a
next-generation approach to microbiome therapy. Defined bacterial
consortia are products of standardized composition manufactured
from cell banks, bypassing the need to rely on donor fecal material
of inconsistent composition.
The investor syndicate was co-led by new investors AXA IM Alts
and The AMR Action Fund, along with existing investors Bill &
Melinda Gates Foundation, Skyviews Life Science, Reimagined
Ventures, Fiscus Ventures, PEAK6, and Atlantic Neptune. New
investors K2 HealthVentures, Korea Investment Partners, Korea
Investment & Securities Asia Ltd. and Korea Investment &
Securities US, Inc., and existing investors including co-founder
PureTech Health, Revelation Partners, QUAD Investment Management,
Seventure Partners, Hambro Perks, and Pfizer Inc. also
participated.
“We are grateful to have the support of our new and existing
investors, who share our vision of pioneering microbiome
therapeutics based on defined bacterial consortia to transform the
lives of patients with serious diseases,” said Bernat Olle, Ph.D.,
Co-founder and Chief Executive Officer of Vedanta Biosciences. “Our
Phase 2 clinical data and this new funding enable us to continue
advancing the microbiome field beyond products made from fecal
donations, and towards pharmaceutical-grade, defined
medicines.”
The primary use of proceeds will be to advance a pivotal Phase 3
study of VE303 in recurrent CDI and a proof-of-concept Phase 2
study of VE202 in ulcerative colitis. Vedanta’s positive Phase 2
data for VE303 in recurrent CDI were recently published in the
Journal of the American Medical Association (JAMA). C. difficile
causes approximately half a million infections each year in the
United States, including up to 165,000 recurring infections and has
been associated with up to 45,000 deaths annually. The positive
results of the Phase 2 study, first reported in October 2021,
triggered a $23.8 million contract option from the Biomedical
Advanced Research and Development Authority (BARDA) to support a
Phase 3 clinical study of VE303. This project has been funded in
part with federal funds from the Department of Health and Human
Services; Administration for Strategic Preparedness and Response;
BARDA, under contract number 75A5012C00177 for a contract value up
to $81.9 million.
In conjunction with their investments, Curt LaBelle, M.D.,
Martin Heidecker, Ph.D., and Neil Tiwari will join Vedanta’s Board
of Directors. Dr. LaBelle has been investing in and working with
healthcare companies for over twenty years and is Managing Partner
of Global Healthcare Strategies at AXA IM Alts. Dr. Heidecker
brings over twenty years of extensive international experience in
venture capital, drug development, and pharmaceutical marketing,
and is the Chief Investment Officer of The AMR Action Fund. Mr.
Tiwari brings over fifteen years of healthcare experience in
medical devices, pharmaceuticals, biotechnology, and health
technology as an operator, investor, and board member, and is a
healthcare, life sciences, and technology investor at Magnetar
Capital.
In addition, two directors will conclude their tenure on
Vedanta’s board, including Christopher Viehbacher, recently
appointed Chief Executive Officer of Biogen Inc., and Bharatt
Chowrira, Ph.D., J.D., the President, Chief Business, Legal and
Operating Officer of PureTech Health. Charles Sherwood III,
Associate General Counsel at PureTech, will replace Dr. Chowrira on
the Vedanta Board of Directors.
“We extend our warm thanks to Chris and Bharatt for their
several years of expert guidance and contributions to advancing our
mission, and welcome our new Board members,” said Dr. Olle.
FJS Consultants Limited acted as a placement agent for Vedanta’s
new investors in Korea.
About Vedanta Biosciences Vedanta Biosciences is leading
the development of a potential new category of oral therapies based
on defined consortia of bacteria isolated from the human microbiome
and grown from pure clonal cell banks. The company’s clinical-stage
pipeline includes product candidates being evaluated for the
prevention of recurrent C. difficile infection, inflammatory bowel
diseases, food allergy, and liver disease. These investigational
therapies are grounded in our team’s pioneering research –
published in leading journals including Science, Nature, Cell, and
JAMA – to identify beneficial bacteria that live symbiotically
within the healthy human gut, fight pathogens, and induce a range
of potent immune responses. Vedanta Biosciences controls a
foundational portfolio of more than 70 patents and has built what
it believes is the industry-leading platform for development of
defined bacterial consortia drugs. This platform includes one of
the largest libraries of bacteria derived from the human
microbiome, vast datasets from human interventional studies,
proprietary capabilities in consortium design, and end-to-end
capabilities for CGMP-compliant manufacturing of oral drug
candidates spanning cell banking, fermentation, lyophilization, and
fill finish.
About Defined Bacterial Consortia Defined Bacterial
Consortia are assemblies of bacteria of standardized composition
that act cooperatively to exert a therapeutic effect. The
constituent strains in each consortium are rationally selected from
Vedanta’s extensive in-house strain library, and grown from pure,
clonal cell banks using scalable fermentation processes. Each
capsule contains precisely controlled compositions and doses of the
same live bacterial strains and is formulated for stable oral
delivery to the lower gastrointestinal tract. We believe that our
targeted approach offers consistent composition and quality
attributes, may provide more consistent clinical benefit, limits
safety risk, and enables greater scalability compared with
fecal-derived approaches.
About PureTech Health PureTech is a biotherapeutics
company dedicated to changing the treatment paradigm for
devastating diseases. 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 26 therapeutics and therapeutic candidates,
including two (Plenity® and EndeavorRx®) that have received both
U.S. FDA clearance and European marketing authorization and a third
(KarXT) that will soon be filed for FDA approval, as of the most
recent update by the Company. All of the underlying programs and
platforms that resulted in this pipeline of therapeutic candidates
were initially identified or discovered and then advanced by the
PureTech team through key validation points based on unique
insights in immunology and drug development.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact, including without limitation those
related to the use of funding and timing of the Phase 3 study of
VE303 and the Phase 2 study of VE202, and Vedanta’s and PureTech's
future prospects, development plans and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks, uncertainties and other
important factors that could cause actual results, performance and
achievements to differ materially from current expectations,
including, but not limited to, those risks, uncertainties and other
important factors described under the caption "Risk Factors" in our
Annual Report on Form 20-F for the year ended December 31, 2021
filed with the SEC and in our other regulatory filings. 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, we
disclaim any obligation to update or revise these forward-looking
statements, whether as a result of new information, future events
or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230425005397/en/
PureTech Public Relations
publicrelations@puretechhealth.com Investor Relations
IR@puretechhealth.com
EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
PureTech Health (NASDAQ:PRTC)
Historical Stock Chart
From Jun 2024 to Jul 2024
PureTech Health (NASDAQ:PRTC)
Historical Stock Chart
From Jul 2023 to Jul 2024