Synlogic Presents Preclinical Data from First Synthetic BioticTM Clinical Candidate in Immuno-Oncology at the Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting

From Startup Synlogic Tx

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– Data highlight the differential advantages of Synthetic Biotic
approach designed to activate the local innate immune system for the
potential treatment of a variety of solid tumors –

– Company will webcast Investor and Analyst event at 12:30 pm ET,
Saturday, November 10, 2018, to discuss supporting preclinical data and
outline future clinical development plans –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 6, 2018–
Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage drug discovery and
development company applying synthetic biology to beneficial microbes to
develop novel living medicines, today announced the presentation of
preclinical data from its first immuno-oncology (IO) program at the 33rd
Annual Meeting & Pre-Conference Programs of the Society for
Immunotherapy of Cancer (SITC 2018). Synlogic’s first Synthetic Biotic
clinical candidate (SYNB1891) is designed to induce the production of
type I interferon (IFN) through dual activation of innate immune
pathways. Data that will be presented at SITC 2018 demonstrate that
SYNB1891 generated significant anti-tumor activity, systemic immunity
and long-term immunological memory in mouse tumor models. The data
highlight the advantages of SYNB1891 for the potential treatment of
cancers that are resistant to current immunotherapy approaches.

“Our goal is to design Synthetic Biotic medicines that enable us to
expand the benefits of immunotherapy broadly across tumor types,” said
Aoife Brennan, M.B., Ch. B., Synlogic’s president and chief executive
officer. “Tumors have multiple mechanisms to evade the immune system and
our Synthetic Biotic platform is uniquely suited to address this area of
unmet medical need given our ability to engineer multiple mechanisms in
a single biotic. We are excited to move this first program into the

“Our Synthetic Biotic drug candidate, SYNB1891, enabled dual activation
of the innate immune system via both the bacterial chassis and its STING
agonist payload in mouse tumor models,” said Jose Lora, Ph.D.,
Synlogic’s vice president of research. “We have engineered a
non-pathogenic bacterial strain to deliver immunostimulatory molecules
directly into the tumor microenvironment, which has the potential to
induce a local immune response and establish systemic immunity while
minimizing systemic toxicity.”

In a presentation, Development of a STING Agonist-producing Synthetic
Biotic™ Medicine to Activate Innate and Adaptive Immunity and Drive
Antitumor Immune Responses, to be given at the SITC 33rd
Annual Meeting on Friday, November 9, 2018, Synlogic scientists will
describe an engineered strain of E. coli Nissle, (SYNB1891) that
produces cyclic di-AMP (CDA) which stimulates the STING pathway. Recent
studies have demonstrated that activation of the STimulator
of INterferon Genes
(STING) pathway can play a critical role in the initiation of an
anti-tumor immune response via activation of antigen presenting cells
(APCs) and presentation of tumor antigens. SYNB1891 can be delivered
directly into the tumor where it remains active for several days to
stimulate a local immune response. When the bacteria are engulfed by
APCs within the tumor, the STING pathway is activated within the cell
resulting in a type I IFN response. In addition, the bacterial chassis
used in Synlogic’s Synthetic Biotic approach is believed to be able to
stimulate the innate immune system by several other mechanisms,
including via Toll-like receptors (TLRs), potentially adding to the
magnitude of the overall immune response.

In preclinical studies that will be presented at SITC 2018, Synlogic has
demonstrated that:

In vitro, SYNB1891 produces biologically-relevant levels of
CDA, activating both mouse and human APCs

In a reporter assay, SYNB1891 induced production of higher levels of
type I IFN protein compared to naked CDA, and in human primary APCs
SYNB1891 treatment resulted in significantly higher expression of
genes encoding type I IFN-beta and IL-6, when compared to naked
STING-agonist treatment

Treatment with the un-engineered E. coli Nissle (SYNB) alone
resulted in increased tumoral innate cytokine levels and anti-tumor
activity, demonstrating that the bacterial chassis itself triggers
complementary innate immunity pathways which are further potentiated
by arming the bacteria with STING agonist

SYNB1891 prototype-treated tumors demonstrate upregulation of an
inflammation-related gene signature

SYNB1891 prototype treatment of B16.F10 melanoma tumors resulted in an
early rise in innate-immune cytokines and at later times resulted in T
cell activation in tumors and tumor-draining lymph nodes

These pharmacodynamic changes correlated with robust anti-tumor
responses and complete tumor regressions

Mice that exhibited complete regression of tumors in response to
SYNB1891 prototype treatment demonstrated long-term immunological
memory when re-challenged with tumor cells >40 days post tumor

Investor and Analyst Event DetailsOn Saturday, November 10,
2018, at the SITC 33rd Annual meeting in Washington D.C.,
Synlogic will also host an Investor and Analyst Event. The program will
feature commentary from experts Filip Janku, M.D., Ph.D., Associate
Professor in the Department of Investigational Cancer Therapeutics and
Center Medical Director for the Clinical and Translational Research
Center at MD Anderson Cancer Center, and Dmitriy Zamarin, M.D., Ph.D.,
Assistant Attending Physician in Gynecologic Medical Oncology and
Immunotherapeutics Services at the Memorial Sloan Kettering Cancer
Center who will discuss the unmet medical need and current landscape in
immuno-oncology, as well as company representatives who will outline
Synlogic’s plans for clinical development of its clinical candidate,

Presentations will begin at 12:30 pm, until 2:00 pm. ET, on Saturday,
November 10, 2018.

The event will be webcast live and available via a link on the company’s
website in the Events
Calendar in the Investors and Media section.

About SynlogicSynlogic 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 beneficial
microbes to perform or deliver critical functions missing or damaged due
to disease. Synthetic Biotic medicines are designed to act locally and
have a systemic effect to address disease in patients. Synlogic’s two
lead programs, SYNB1020 and SYNB1618, are orally administered and target
hyperammonemia as a result of liver damage or genetic disease, and
phenylketonuria, respectively. Synlogic is also developing SYNB1891 as
an intratumorally administered Synthetic Biotic medicine for the
treatment of cancer. In addition, the company is leveraging the broad
potential of its platform to create additional Synthetic Biotic
medicines for the treatment of liver disease, as well as inflammatory
and immune disorders including Synlogic’s collaboration with AbbVie to
develop Synthetic Biotic-based treatments for inflammatory bowel disease
(IBD). For more information, please visit

Forward-Looking StatementsThis 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, 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, liver disease,
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
potential of Synlogic’s technology to treat cancer, hyperammonemia, and
phenylketonuria. 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 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

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Source: Synlogic, Inc.

Synlogic, Inc.MEDIA CONTACT:Courtney Heath,
CONTACT:Elizabeth Wolffe, Ph.D.,

Please visit their site for more information: Synlogic

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2018-11-07 04:40:38