CAMBRIDGE, Mass. and
BOSTON, Nov. 9, 2021 /PRNewswire/ -- Synlogic, Inc.
(Nasdaq: SYBX), a clinical-stage company bringing the
transformative potential of synthetic biology to medicine, and
Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for
cell programming, today announced the nomination of SYNB1353, an
investigational Synthetic BioticTM medicine for the
treatment of homocystinuria (HCU). SYNB1353 is the first product
developed through a research collaboration between Synlogic and
Ginkgo and the first investigational medicine developed on Ginkgo's
platform to enter IND-enabling studies. Synlogic expects to file an
investigational new drug (IND) application with the U.S. Food and
Drug Administration (FDA) for SYNB1353 and begin clinical
development in 2022.
"SYNB1353 is an exciting addition to the Synlogic pipeline aimed
at helping patients living with diseases of methionine metabolism.
Starting with HCU, we see these diseases as the natural next step
in our metabolic portfolio after the successful proof of concept of
synthetic biotics in phenylketonuria announced earlier this year.
This program builds on what we have learned from our metabolic
program work to date, with the potential to provide a new
therapeutic option to reduce the devastating consequences of these
diseases," said Dr. David Hava, chief scientific officer at
Synlogic. "The advancement of SYNB1353 illustrates both the
potential of our Synthetic Biotic platform to generate new
therapeutic candidates and the value of our collaboration with
Ginkgo."
"We're so honored to be able to support Synlogic in building
their incredible platform to provide potential new treatment
options for people living with difficult to treat diseases," said
Patrick Boyle, head of codebase at
Ginkgo. "This is just the beginning for a new generation of
medicines unlocked by the power of synthetic biology, and we're
excited to be working with Synlogic on multiple additional
preclinical programs in their portfolio."
HCU is an inherited disorder caused by the loss of function of
cystathionine beta-synthase, which results in excessive
accumulation of homocysteine and its metabolites in the blood and
urine. Patients develop multisystem clinical manifestations,
including ectopia lentis, bone defects, intellectual disability,
and life-threatening thromboembolisms. Many patients are required
to comply with a rigid methionine-restricted diet and have few
treatment options available.
SYNB1353 is an engineered strain of the probiotic bacteria E.
coli Nissle (EcN) which consumes methionine within the
gastrointestinal tract, preventing methionine absorption and
conversion to homocysteine in plasma. During the collaboration,
SYNB1353 was designed using Ginkgo's proprietary codebase. The
high-throughput testing of codebase libraries by Ginkgo enabled
SYNB1353 to advance from preclinical proof-of-concept to candidate
strain in the space of a year.
Researchers from Synlogic and Ginkgo will present preclinical
data supporting advancement of SYNB1353 into IND-enabling studies
at the International Congress of Inborn Errors of Metabolism 2021.
The poster, Development of an Investigational
Methionine-consuming Synthetic Biotic Medicine (SYNB1353) for the
Treatment of Homocystinuria, will be available at the
International Congress of Inborn Errors of Metabolism 2021 on
November 21-23, 2021 in Sydney, Australia.
Following the event, the poster will also be available to view
on www.synlogictx.com.
About SYNB1353
SYNB1353 is a novel medicine in
development for the treatment of diseases of methionine metabolism
including homocystinuria (HCU). SYNB1353 is designed to lower
plasma homocysteine levels by metabolizing methionine, a precursor
to homocysteine, in the gastrointestinal (GI) tract. SYNB1353 was
developed using Synlogic's Synthetic Biotic platform incorporating
components of Ginkgo Bioworks' codebase. Synlogic holds worldwide
development and commercialization rights to SYNB1353.
About Synlogic
Synlogic is bringing the transformative
potential of synthetic biology to medicine. With a premier
synthetic biology platform that leverages a reproducible, modular
approach to microbial engineering, Synlogic designs Synthetic
Biotic medicines that target validated underlying biology to treat
disease in new ways. Synlogic's proprietary pipeline includes
Synthetic Biotics for the treatment of metabolic disorders
including phenylketonuria (PKU) and enteric hyperoxaluria. The
company is also building a portfolio of partner-able assets in
immunology and oncology. Learn more about Synlogic's programs and
pipeline by visiting https://www.synlogictx.com/.
About Ginkgo Bioworks
Ginkgo is building a platform to
enable customers to program cells as easily as we can program
computers. The company's platform is enabling biotechnology
applications across diverse markets, from food and agriculture to
industrial chemicals to pharmaceuticals. Ginkgo has also actively
supported a number of COVID-19 response efforts, including K-12
pooled testing, vaccine manufacturing optimization and therapeutics
discovery. For more information,
visit www.ginkgobioworks.com.
About the Synlogic - Ginkgo Collaboration
Formed in
2019, the Synlogic - Ginkgo collaboration is a five year,
$30M strategic platform collaboration
which accelerates expansion and development of Synlogic's pipeline
of Synthetic Biotic medicines using Ginkgo's cell programming
platform, including Ginkgo's foundry and codebase. Synlogic has
exclusive rights to any Synthetic Biotic medicines that it develops
as part of the collaboration and to certain intellectual property
covering such products.
Forward-Looking Statements of Synlogic, Inc.
This
press release contains "forward-looking statements" that involve
substantial risks and uncertainties for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995.
All statements, other than statements of historical facts, included
in this press release regarding strategy, future operations,
clinical development plans, future financial position, future
revenue, projected expenses, prospects, plans and objectives of
management are forward-looking statements. In addition, when or if
used in this press release, the words "may," "could," "should,"
"anticipate," "believe," "estimate," "expect," "intend," "plan,"
"predict" and similar expressions and their variants, as they
relate to Synlogic may identify forward-looking statements.
Examples of forward-looking statements, include, but are not
limited to, statements regarding the potential of Synlogic's
platform to develop therapeutics to address a wide range of
diseases including: cancer, inborn errors of metabolism, diseases
of methionine metabolism, and inflammatory and immune disorders;
our expectations about sufficiency of our existing cash balance;
the future clinical development of Synthetic Biotic medicines; the
approach Synlogic is taking to discover and develop novel
therapeutics using synthetic biology; and the expected timing of
Synlogic's clinical trials and availability of clinical trial data.
Actual results could differ materially from those contained in any
forward-looking statement as a result of various factors,
including: the uncertainties inherent in the clinical and
preclinical development process; the ability of Synlogic to protect
its intellectual property rights; and legislative, regulatory,
political and economic developments, as well as those risks
identified under the heading "Risk Factors" in Synlogic's filings
with the SEC. The forward-looking statements contained in this
press release reflect Synlogic's current views with respect to
future events. Synlogic anticipates that subsequent events and
developments will cause its views to change. However, while
Synlogic may elect to update these forward-looking statements in
the future, Synlogic specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon as
representing Synlogic's view as of any date subsequent to the date
hereof.
Forward-Looking Statements of Ginkgo
Bioworks
This press release contains certain
forward-looking statements within the meaning of the federal
securities laws, including statements regarding the potential
success of the partnership and Ginkgo's cell programming platform.
These forward-looking statements generally are identified by the
words "believe," "project," "potential," "expect," "anticipate,"
"estimate," "intend," "strategy," "future," "opportunity," "plan,"
"may," "should," "will," "would," "will be," "will continue," "will
likely result," and similar expressions. Forward-looking statements
are predictions, projections and other statements about future
events that are based on current expectations and assumptions and,
as a result, are subject to risks and uncertainties. Many factors
could cause actual future events to differ materially from the
forward-looking statements in this document, including but not
limited to: (i) the effect of the business combination with Soaring
Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business
relationships, performance, and business generally, (ii) risks that
the business combination disrupts current plans of Ginkgo and
potential difficulties in Ginkgo's employee retention, (iii) the
outcome of any legal proceedings that may be instituted against
Ginkgo related to its business combination with Soaring Eagle, (iv)
volatility in the price of Ginkgo's securities now that it is a
public company due to a variety of factors, including changes in
the competitive and highly regulated industries in which Ginkgo
plans to operate, variations in performance across competitors,
changes in laws and regulations affecting Ginkgo's business and
changes in the combined capital structure, (v) the ability to
implement business plans, forecasts, and other expectations after
the completion of the business combination, and identify and
realize additional opportunities, and (vi) the risk of downturns in
demand for products using synthetic biology. The foregoing list of
factors is not exhaustive. You should carefully consider the
foregoing factors and the other risks and uncertainties described
in the "Risk Factors" section of Ginkgo's current report on Form
8-K filed with the U.S. Securities and Exchange Commission (the
"SEC") on September 20, 2021 and
other documents filed by Ginkgo from time to time with the SEC.
These filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking statements.
Forward-looking statements speak only as of the date they are made.
Readers are cautioned not to put undue reliance on forward-looking
statements, and Ginkgo assumes no obligation and does not intend to
update or revise these forward-looking statements, whether as a
result of new information, future events, or otherwise. Ginkgo does
not give any assurance that it will achieve its expectations.
SYNLOGIC INVESTOR CONTACT:
Daniel Rosan
Synlogic, Inc.
617-401-9152
dan.rosan@synlogictx.com
SYNLOGIC MEDIA CONTACT:
Jenna
Urban
Berry & Company Public Relations
212-253-8881
jurban@berrypr.com
GINKGO BIOWORKS INVESTOR CONTACT:
investors@ginkgobioworks.com
GINKGO BIOWORKS MEDIA
CONTACT:
press@ginkgobioworks.com
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SOURCE Ginkgo Bioworks