Corporate news
SER-109 has
the potential to be the first-ever live
biotherapeutic product (LBP) to
be produced commercially; the
collaboration with Seres Therapeutics is a critical milestone for Bacthera,
a joint venture between a Lonza
Group Affiliate and Chr. Hansen.
Basel,
Switzerland and Hørsholm, Denmark, 10
November 2021 – Bacthera,
a specialized contract development and manufacturing organization (CDMO), and
Seres Therapeutics, a leading microbiome therapeutics company, announced today
a collaboration to manufacture SER-109, Seres’ lead
product candidate for recurrent Clostridioides difficile infection
(rCDI).
Under the terms of the agreement, Bacthera is
establishing a dedicated facility for commercial manufacturing in its new
Microbiome Center of Excellence, a manufacturing site dedicated to the
production of LBP’s located on Lonza’s Ibex® campus in Visp,
Switzerland.
CDI,
causing severe diarrhea and colitis, an inflammation of the colon, has been
classified as one of the greatest microbial threats to human health by the
Centers for Disease Control and Prevention (CDC). It is the leading cause of
hospital-acquired infections in the
United States and is responsible for 170,000
hospitalizations and the deaths of more than 20,000
Americans each year.1 SER-109 is a potentially first-in-class investigational microbiome-based
therapeutic consisting of bacterial spores from healthy
human donors. This consortium of
human microbiota from the gastrointestinal tract is designed
to prevent further recurrences of C. difficile infections.
Lukas
Schüpbach, CEO, Bacthera, commented: "Bacthera's ambition
is to enable our customers such as Seres Therapeutics to bring life-changing
treatments to patients by pioneering the Live
Biotherapeutic Product industry. With this significant
agreement, we are one step closer to making that happen, and we are proud to be
part of bringing an
entirely new class of medicines to people who have a profound need for it.
With our new Microbiome Center
of Excellence in Visp,
we are looking forward to supporting the manufacturing of potentially life-saving
microbiome-based treatments, such as SER-109."
Eric
Shaff, CEO, Seres,
added: “Our
mission at Seres is to transform the lives of patients worldwide with
revolutionary microbiome therapeutics. We are
pleased with the progress we have made to prepare
for an expected biologics
license application submission in mid-2022, and look
forward to partnering with Bacthera to
expand upon our existing production
capacity to meet demand growth beyond the initial phase of launch and
help ensure eligible patients worldwide can
receive this potential new
treatment option.”
Commercial manufacturing capacities
The
agreement between Bacthera and
Seres Therapeutics aims to expand upon Seres’ initial commercial
manufacturing supply chain. In
addition to Seres’ existing manufacturing infrastructure, the collaboration
with Bacthera will
expand the commercial production capacities of SER-109 and provide supply support. SER-109 has
the potential to be the first product within
the entire live biotherapeutic industry to be produced commercially. To
support the commercial manufacturing needs of
SER-109 and other LBPs, Bacthera is
establishing a new Microbiome Center
of Excellence dedicated to LBP Manufacturing
at Lonza's site in Visp,
Switzerland.
The
new Microbiome Center of Excellence will
be based
on Lonza's proven
Ibex® Solutions concept
for manufacturing, providing capacity for early commercial launches and
production. The new
Microbiome Center of Excellence will
occupy an overall footprint of approximately 12’000 m2 with
three manufacturing floors,
including capacity for commercial production. One of
the three manufacturing floors will
be dedicated to the manufacturing of SER-109.
Jean-Christoph Hyvert,
President, Biologics and Cell and Gene, Lonza, commented: "This
collaboration truly exemplifies Bacthera's leading offering for
LBP manufacturing as
a strategic partner on the path to commercialization. Bacthera will
utilize a facility inspired by the Ibex® Solutions to offer
flexibility, speed, and assured supply, enabling its customers to
mark a significant milestone in the
advance of microbiome-targeting therapies."
Under
the terms of the agreement, Bacthera will
provide GMP drug substance manufacturing and
filling of the final drug product formulation
into capsules. The capsules will leverage Lonza’s Capsugel® hypromellose (HPMC)
plant-based capsule
portfolio combined with encapsulation
technologies that are scientifically designed
to improve
the stability of the product by ensuring protection from humidity,
gastric acid and other environmental factors.
Christian Barker,
Executive Vice President Health & Nutrition, Chr. Hansen: "With Bacthera,
we are on a mission to pioneer the future of medicine based on good bacteria.
While Bacthera has
already been successful in winning and executing several projects for customers
based in Europe, the US and Asia, we consider this first commercial manufacturing
agreement a breakthrough in our microbiome lighthouse. This will support Bacthera in
becoming a world-leading CDMO in the emerging Live Biotherapeutic Product industry."
About
SER-109
SER-109 is an oral microbiome therapeutic candidate consisting
of a consortium of highly purified Firmicutes spores, which normally live in
the healthy microbiome. SER-109 is designed to prevent further recurrences of
CDI in patients with a history of multiple infections by modulating the
disrupted microbiome to a state that resists C. difficile colonization
and growth. The SER-109 manufacturing purification process is designed to
remove unwanted microbes, thereby
reducing the risk of pathogen transmission beyond donor screening alone. The US FDA has
granted SER-109 Breakthrough Therapy designation and Orphan Drug designation
for the treatment of rCDI.
About Live Biotherapeutic Products
LBPs
for short or more popularly known as bugs-as-drug, are a new therapeutic
modality being developed by a range of biotech and pharma companies across the
world. LBPs are unique because their active substance is a living organism,
most commonly a bacterium, that has been identified as showing promise in
treating one or sometimes several diseases. LBPs are diverse and can consist of e.g. a
single organism, a genetically modified organism, or a consortium of organisms.
About Bacthera
Bacthera was
founded in 2019 as a 50:50 Joint Venture of Chr. Hansen A/S and a Lonza Group
Affiliate to specifically
serve the needs of the emerging LBP industry. Bacthera's expertise
and the capabilities of production of bacteria for pharmaceutical purposes were
transferred by both parent companies to Bacthera right
from the beginning. Bacthera offers a
compelling set of services across the LBP life cycle and process chain, from
technical R&D development right through to GMP manufacture and QC testing
of drug substance and drug product.
Bacthera operates
from its Headquarter and Center of Excellence for drug product process
development and manufacturing, and QC analytical testing in Basel, CH, and its
Center of Excellence for drug substance process development, analytical development,
and manufacturing in Hørsholm, DK.
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@Bacthera on LinkedIn
About
Seres Therapeutics
Seres
Therapeutics, Inc. (Nasdaq:
MCRB) is a leading microbiome therapeutics company developing a novel class of
multifunctional bacterial consortia that are designed to functionally interact
with host cells and tissues to treat disease. Seres’ SER-109 program achieved
the first-ever positive pivotal clinical results for a targeted microbiome drug
candidate and has obtained Breakthrough Therapy and Orphan Drug designations
from the FDA. The SER-109 program is being advanced for the treatment of
recurrent C.
difficile infection
and has potential to become a first-in-class FDA-approved microbiome
therapeutic. Seres is evaluating SER-301 in a Phase 1b study in patients with
ulcerative colitis and SER-155 in a Phase 1b study to address gastrointestinal
infections, bacteremia and graft-versus-host disease.
For more information, please visit www.serestherapeutics.com.
Seres entered into an agreement with
Nestlé Health Science in July
2021 to
jointly commercialize SER-109 in the US and Canada. Under the terms of the agreement,
Nestlé Health Science will utilize its global pharmaceutical business, Aimmune Therapeutics, which has a strong presence in the
field of gastroenterology, allowing it to lead
the commercialization of SER-109 while providing Seres the ability to retain a
strategic role and actively participate in the launch.
About
Lonza
Lonza
is the preferred global partner to the pharmaceutical, biotech and nutrition
markets. We work to enable a healthier world by supporting our customers to
deliver new and innovative medicines that help treat a wide range of diseases.
We achieve this by combining technological insight with world-class
manufacturing, scientific expertise and process excellence. Our unparalleled
breadth of offerings enables our customers to commercialize their discoveries
and innovations in the healthcare sector.
Founded
in 1897 in the Swiss Alps, today, Lonza operates across five continents. With
approximately 15,000 full-time employees, we comprise high-performing teams and
individual talent that make a meaningful difference to our own business, as
well as to the communities in which we operate. The company generated sales of
CHF 2.5 billion with a CORE EBITDA of
CHF 847 million in H1 2021. Find out more at www.lonza.com
Follow
@Lonza on LinkedIn
Follow
@LonzaGroup on Twitter
About
Chr. Hansen
Chr.
Hansen is a global, differentiated bioscience company that develops natural
ingredient solutions for the food, nutritional, pharmaceutical and agricultural
industries. At Chr. Hansen we are uniquely positioned to drive positive change
through microbial solutions. We have worked for over 145 years to enable
sustainable agriculture, better food and healthier living for more people
around the world. Our microbial and fermentation technology platforms,
including our broad and relevant collection of around 40,000 microbial strains,
have game-changing potential. Matching customer needs and global trends we
continue to unlock the power of good bacteria to respond to global challenges
such as food waste, global health and the overuse of antibiotics and pesticides.
As the world’s most sustainable food ingredients company, we touch the lives of
more than 1 billion people every day. Driven by our legacy of innovation and
curiosity to pioneer science, our purpose – To grow a better world. Naturally.
– is at the heart of everything we do.
Bacthera Contact Details
Felix
Faupel
Chief
Commercial Officer
Bacthera AG
Tel
+41 79 347 10 02
Seres Therapeutics Contact Details
Kristin
Ainsworth
SVP,
Corporate Communications
Kainsworth@serestherapeutics.com
Carlo
Tanzi,
Ph.D.
Head,
Investor Relations
Additional
Information and Disclaimer
Lonza
Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX
Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities
Trading Limited ("SGX-ST"). Lonza
Group Ltd is not subject to the SGX-ST's continuing
listing requirements but remains subject to Rules 217 and 751 of the SGX-ST
Listing Manual.
Certain
matters discussed in this news release may constitute forward-looking
statements. These statements are based on current expectations and estimates of
Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these
expectations and estimates will be achieved. Investors are cautioned that all
forward-looking statements involve risks and uncertainty and are qualified in
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forward-looking statements included in this news release due to various
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disclaims any intention or obligation to update the statements contained in
this news release.
Chr.
Hansen’s forward-looking statements
This
press release contains forward-looking statements that reflect management’s
current views with respect to certain future events and potential financial
performance. Forward-looking statements are other than statements of historical
facts. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,”
“outlook,” “will,” “may,” “continue,” “should” and similar expressions identify
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regarding: objectives, goals, strategies, outlook and growth prospects; future
plans, events or performance and potential for future growth; liquidity,
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and the strength of competitors. The forward-looking statements in this press
release are based upon various assumptions, many of which are based, in turn,
upon further assumptions, including without limitation, management’s
examination of historical operating trends, data contained in records and other
data available from third parties. Although the Company believes that these
assumptions were reasonable when made, these assumptions are inherently subject
to significant known and unknown risks, uncertainties, contingencies and other
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to differ materially from those results expressed or implied in this press
release by such forward-looking statements. The information, opinions and
forward-looking statements contained in this report speak only as at the date
of this press release, and are subject to change without notice. The Company
and its respective agents, employees or advisors do not intend to, and
expressly disclaim any duty, undertaking or obligation to, make or disseminate
any supplement, amendment, update or revision to any of the information,
opinions or forward-looking statements contained in this press release to
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Seres Therapeutics 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 Seres’ manufacturing
plans and the potential benefits of Seres’ collaboration
with Bacthera, the
potential approval of SER-109 and its status as a first-in-class therapeutic and
as the first-ever live biotherapeutic product, the timing
of a BLA filing and of initiating commercial
manufacturing, the
potential of microbiome therapeutics to treat and prevent disease, the timing
and results of Seres’ clinical
studies, the ultimate safety and efficacy data for Seres’ products,
and other statements which are not historical fact.
These forward-looking statements relating
to Seres are based on Seres’ management’s
current expectations. These statements are neither promises nor guarantees, but
involve known and unknown risks, uncertainties and other important factors that
may cause our actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not limited to, the
following: Seres has incurred
significant losses, is not
currently profitable and may never become profitable; Seres’ need
for additional funding; Seres’ limited
operating history; the impact of the COVID-19 pandemic; Seres’ unproven
approach to therapeutic intervention; and Seres’ reliance
on third parties and collaborators to manufacture product
candidates and develop and commercialize product candidates, if approved. These
and other important factors discussed under the caption “Risk Factors” in Seres’ Quarterly
Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC,
on August
3,
2021,
and its other
reports filed with the SEC could cause actual results to differ materially from
those indicated by the forward-looking statements made in this press release.
Any such forward-looking statements about
Seres represent Seres’ management’s
estimates as of the date of this press release. While Seres may
elect to update such forward-looking statements at some point in the future, it disclaims any
obligation to do so, even if subsequent events cause Seres’ views
to change. These forward-looking statements should not be relied upon as
representing Seres’ views
as of any date subsequent to the date of this press release.