CAMBRIDGE, Mass., June 1, 2020 /PRNewswire/ -- Synlogic, Inc.,
(Nasdaq: SYBX) a clinical stage company applying synthetic biology
to beneficial microbes to develop novel, living medicines, today
announced the publication in Nature Communications of
preclinical data supporting its first clinical immuno-oncology
program, SYNB1891, which is being evaluated in a Phase 1 clinical
trial in patients with advanced solid tumors or lymphoma.
Data described in the publication demonstrate that SYNB1891
treatment cleared tumors and stimulated antitumor immunity in
preclinical models of cancer.
"The targeted delivery and dual immune stimulatory activity of
SYNB1891 offer distinct advantages over other approaches," said
Aoife Brennan, M.B., Ch. B.,
Synlogic's president and chief executive officer. "The preclinical
data published today highlight the transformative potential of
SYNB1891. Together with the early experience in the clinic
demonstrating feasibility and tolerability in the initial cohorts
of the clinical trial, these data provide support for the
continued development of SYNB1891 as a potential therapeutic option
to expand the benefits of immunotherapy to more patients with
cancer."
The publication titled, "Immunotherapy with an engineered
bacteria by targeting the STING pathway for anti-tumor
immunity," details the engineering and characterization of
SYNB1891. The work describes preclinical studies that demonstrate
anti-tumor activity and generation of immunological memory by
SYNB1891 in mouse models of cancer, as well as its robust
activation of human antigen presenting cells (APCs) that are key to
the generation of an anti-tumoral immune response.
SYNB1891 is an engineered strain of E. coli Nissle, that
produces cyclic di-AMP (CDA), a stimulator of the STING (STimulator
of INterferon Genes) pathway. This mechanism can play a
critical role in the initiation of an anti-tumor immune response
via activation of APCs and presentation of tumor antigens. The
bacterial chassis of SYNB1891 also stimulates the innate immune
system by several other mechanisms, including via Toll-like
receptors (TLRs), potentially adding to the magnitude of the
overall immune response. A notable advantage of SYNB1891 is that
the STING agonist is not released by the bacteria until they have
been engulfed by the target cells (APCs) and so there is less risk
of deleterious effects on other immune cells such as T-cells. Also,
while SYNB1891 has been engineered with safety features that are
designed to prevent its replication unless supplemented with
specific nutrients, the bacteria remain active for several days
within the injected tumor to stimulate a local immune response.
Intra-tumorally administered SYNB1891 is being evaluated as a
monotherapy in an ongoing Phase 1 open-label, multicenter, dose
escalation clinical trial (NCT04167137) in patients with advanced
solid tumors or lymphoma. Synlogic expects to release data from the
monotherapy arm of this study in late 2020. After establishing a
maximum tolerated dose for SYNB1891 as monotherapy, Synlogic
expects to initiate a second arm of the trial in which subjects
will receive escalating dose levels of SYNB1891 in combination with
a fixed dose of the checkpoint inhibitor, atezolizumab
(Tecentriq®), to establish a recommended dose for the combination
regimen.
The DOI for the paper is 10.1038/s41467-020-16602-0.
About Synlogic
Synlogic is pioneering the development
of a novel class of living medicines, Synthetic Biotic medicines,
based on its proprietary drug development platform. Synlogic
leverages the tools and principles of synthetic biology to
genetically engineer probiotic microbes to perform or deliver
critical functions missing or damaged due to disease. The Company's
lead program, SYNB1618, targets PKU. When delivered orally,
Synthetic Biotic medicines can act from the gut to compensate for
the dysfunctional metabolic pathway and have a systemic effect,
with the potential to significantly improve symptoms of disease for
affected patients. In addition, Synlogic is leveraging the broad
potential of its platform to create Synthetic Biotic medicines for
the treatment of more common diseases, including inflammatory and
immune disorders, and cancer. Synlogic's first immuno-oncology
program, SYNB1891, is in clinical development for the treatment of
solid tumors and lymphoma. For more information, please visit
www.synlogictx.com.
Forward-Looking Statements
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, and inflammatory and
immune disorders; the future clinical development of Synthetic
Biotic medicines; the approach Synlogic is taking to discover and
develop novel therapeutics using synthetic biology; the expected
timing of Synlogic's clinical trials and availability of clinical
trial data; the timing and progress of our Phase 1 clinical trial
of SYNB1891 in patients with advanced solid tumors or lymphoma; and
the potential benefits of SYNB1891. 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.
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