Multi-product CGMP facility designed to meet
global regulatory standards for the manufacture of oral therapies
based on defined bacterial consortia
Facility will supply planned Phase 3 clinical
trial and potential commercial launch of VE303 in Clostridioides
difficile infection
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company noted that its
Founded Entity, Vedanta Biosciences, Inc. (“Vedanta”), today
announced the opening of a new facility designed to manufacture
clinical and commercial supply for its therapeutic portfolio,
including for the planned Phase 3 study and potential commercial
launch of its lead candidate, VE303, in Clostridioides difficile
infection. The large-scale Current Good Manufacturing Practice
(CGMP) facility builds on the company’s existing manufacturing
capabilities and can produce multiple drug candidates in a manner
compliant with global regulatory standards, supporting Vedanta’s
clinical expansion. With this facility, Vedanta has CGMP
capabilities from clinical development to commercial launch,
underscoring its leadership in the discovery, development, and
manufacture of drugs based on defined bacterial consortia.
Vedanta believes it was the first company to manufacture
CGMP-grade defined bacterial consortia in powdered form, which
enables stable, consistent oral formulations. Vedanta has also
demonstrated its ability to reliably produce defined bacterial
consortia, by manufacturing several hundred CGMP batches
encompassing over 30 phylogenetically-diverse anaerobic bacterial
species that are representative of the biodiversity in the human
gut and advancing five product candidates to the clinic.
The first production runs at the new facility will supply a
planned Phase 3 study of VE303, an orally administered, defined
bacterial consortium candidate for high-risk Clostridioides
difficile (CDI) infection.
The full text of the announcement from Vedanta is as
follows:
Vedanta Unveils State-of-the-Art
Manufacturing Facility to Provide Clinical and Commercial Supply of
Oral Therapies Based on Defined Bacterial Consortia
Multi-product CGMP facility designed to meet
global regulatory standards for the manufacture of oral therapies
based on defined bacterial consortia
Facility will supply planned Phase 3 clinical
trial and potential commercial launch of VE303 in Clostridioides
difficile infection
CAMBRIDGE, MA – Vedanta Biosciences, a clinical-stage
biopharmaceutical company pioneering the development of oral
therapies based on defined bacterial consortia, today announced the
opening of a new facility designed to manufacture clinical and
commercial supply for its therapeutic portfolio, including for the
planned Phase 3 study and potential commercial launch of its lead
candidate, VE303, in Clostridioides difficile infection. The
large-scale Current Good Manufacturing Practice (CGMP) facility
builds on the company’s existing manufacturing capabilities and can
produce multiple drug candidates in a manner compliant with global
regulatory standards, supporting Vedanta’s clinical expansion. With
this facility, Vedanta has CGMP capabilities from clinical
development to commercial launch, underscoring its leadership in
the discovery, development, and manufacture of drugs based on
defined bacterial consortia.
“We believe that taking a targeted approach to modulation of the
human microbiota, using rigorously controlled and defined
pharmaceutical-grade compositions, will be instrumental to the
evolution of microbiome-based therapies into a reliable new drug
modality for patients across a range of indications,” said Bernat
Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences. “This
facility, combined with the expertise and talent of our team, is
designed to manufacture our microbiome product candidates as
standardized compositions with consistent quality attributes at a
large scale.”
“We saw early on in Vedanta’s existence that the manufacturing
capabilities required for this new drug modality were not yet
established in our field, particularly those involving consortia of
anaerobes or spore-forming strains, which comprise the majority of
human intestinal bacteria,” said Dan Couto, Chief Operating Officer
of Vedanta Biosciences. “Today, we have industrialized an
end-to-end manufacturing process for this class of product
candidates, at commercial scale, by solving an array of technical
challenges related to CGMP production of defined bacterial
consortia. We believe this in-house capability mitigates potential
delays associated with technology transfer to third parties,
empowers us to expedite advancing product candidates that show
promise in early studies, and protects key intellectual property
and know-how.”
Vedanta believes it was the first company to manufacture
CGMP-grade defined bacterial consortia in powdered form, which
enables stable, consistent oral formulations. The company has also
demonstrated its ability to reliably produce defined bacterial
consortia, by manufacturing several hundred CGMP batches
encompassing over 30 phylogenetically-diverse anaerobic bacterial
species that are representative of the biodiversity in the human
gut and advancing five product candidates to the clinic.
The first production runs at the new facility will supply a
planned Phase 3 study of VE303, an orally administered, defined
bacterial consortium candidate for high-risk Clostridioides
difficile (CDI) infection. Every year, CDI contributes
approximately 45,000 deaths in the U.S. In a Phase 2 study that
enrolled patients at high risk of recurrence, VE303 met its primary
endpoint of preventing CDI recurrence at eight weeks. This was the
most advanced clinical trial of an investigational drug based on a
defined bacterial consortium to date.
About Vedanta’s Manufacturing Platform
Vedanta’s industry-leading process for the manufacture of
defined bacterial consortia is based on the isolation and storage
of individual strains of bacteria in clonal cell banks, their
subsequent fermentation, lyophilization, blending into defined
consortia, and filling into capsules for oral administration to the
patient. The company’s platform spans end-to-end capabilities, from
master cell banking to drug substance and drug product
manufacturing, from early clinical phase to commercial launch. The
process consists of the following key steps:
Isolation and Banking of Individual Strains: The
manufacturing process begins with cell banks of individually
isolated strains of bacteria, identified through proprietary
screens as being essential members of a consortium with therapeutic
potential. This approach bypasses the reliance on fecal matter
donations of inconsistent composition from human donors, and
eliminates the risk of pathogen transfer from such donations.
Vedanta has established CGMP master cell banks for over 30
different strains of gut-dwelling bacterial species and intends to
more than double its number of CGMP cell banks in 2022.
Fermentation: The bacterial strains used in Vedanta’s
product candidates are anaerobic (requiring an oxygen-free
environment) and many are spore-formers (requiring containment),
which present unique manufacturing challenges. The company has
developed proprietary processes, including growth media and precise
control conditions, that enable fermentation of anaerobes. The
company’s in-house facilities are configured to ensure segregation
and process containment. These features provide Vedanta the
flexibility to operate a multi-product facility and to handle both
spore-forming and non-spore-forming bacteria.
Formulation and Lyophilization: Lyophilization is a
freeze-drying process, whereby a product is dried by removing water
under low temperature and vacuum conditions. This process can place
considerable stress on bacteria and hinder their ability to regain
metabolic activity when delivered to the gut of a patient. The
company has developed proprietary formulations to stabilize a wide
range of bacterial strains and has demonstrated stability at
refrigerated temperatures for multi-year storage of its drug
product capsules.
Blending, Fill, and Finish: The individual strains in
lyophilized powder form are blended into defined consortia and
filled in capsules for oral administration that are designed to
resist stomach acid and release the bacteria in the intestine.
Vedanta can precisely adjust and blend each strain during drug
product manufacturing to ensure that every capsule contains the
same composition and dose. In contrast, human fecal donations
intrinsically vary from donor to donor and from donation to
donation, resulting in a final product with different composition
and dose of each bacterial species across every batch.
The company utilizes proprietary processes at each step and has
accumulated a wealth of institutional knowledge that has proven
broadly applicable to product processing and stabilization. In
addition to the new multi-product launch-scale CGMP facility,
Vedanta has manufacturing facilities in Cambridge and Acton, MA,
which supply Phase 1 and Phase 2 clinical trials.
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 treatment of high-risk
C. difficile infection, inflammatory bowel diseases, food allergy,
liver disease, and cancer. These investigational therapies are
grounded in pioneering research – published in leading journals
including Science, Nature, and Cell – 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
45 patents and has built what it believes is one of the largest
libraries of bacteria derived from the human microbiome.
Proprietary capabilities include deep expertise in consortium
design, vast datasets from human interventional studies, and
CGMP-compliant manufacturing of oral Live Biotherapeutic Product
(LBP) candidates containing pure, clonally-derived bacterial
consortia in powdered form. Vedanta Biosciences was founded by
PureTech Health (Nasdaq: PRTC, LSE: PRTC) and a global team of
scientific co-founders who pioneered the modern understanding of
the cross-talk between the microbiome and the immune system.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, 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 27
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Annual Report and corresponding Form 6-K. 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 should be considered
forward-looking statements, including without limitation statements
that relate to Vedanta’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.
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