Synlogic in clinical collaboration with Roche to explore Synlogic’s Synthetic Biotic medicine for advanced solid tumors

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Synlogic,
Inc., (Nasdaq: SYBX) a clinical stage company applying synthetic
biology to beneficial microbes to develop novel, living medicines, today
announced a new clinical collaboration with Roche (SIX:RO, ROG), to
explore Synlogic’s Synthetic Biotic™ medicine, SYNB1891, a dual innate
immune activator engineered to express a STING agonist, in combination
with Roche’s PD-L1-blocking checkpoint inhibitor (CPI) atezolizumab
(Tecentriq^®) in patients with advanced solid tumors. Synlogic
expects to file an Investigational New Drug (IND) application with the
U.S. Federal Drug Administration (FDA) in the second half of 2019 for
SYNB1891 to enable the company to begin an open-label Phase 1 clinical
trial to evaluate the candidate as a monotherapy and a combination
treatment with atezolizumab.

“This collaboration is an important step in advancing SYNB1891 as a
potential treatment for difficult to treat cancers as it provides us
with access to an important checkpoint inhibitor, atezolizumab, while
allowing us to maintain ownership of our novel development candidate,”
said Aoife Brennan, M.B. Ch.B., Synlogic’s president and chief executive
officer. “We believe that SYNB1891 has potential to offer a new and
meaningful approach in the fight against cancer when used in combination
with checkpoint inhibitors, by potentially enhancing their potency and
effectiveness.”

Tumors have developed mechanisms to subvert natural processes to
suppress and evade immune control. While the use of CPIs has greatly
improved outcomes for patients with certain types of cancers, a
percentage of patients still do not respond to these therapies.
Engagement of both the innate and adaptive arms of the immune system has
been shown to be critical in generating an efficacious antitumor immune
response.

SYNB1891 is a non-pathogenic strain of E.coli that has been
engineered to express a STING (STimulator of INterferon Genes) agonist
and stimulate the innate immune system. When the bacteria are engulfed
by antigen presenting cells within the tumor, the STING pathway is
activated within the cell resulting in a type I interferon (IFN)
response and the initiation and propagation of tumor-specific T-cell
responses. In addition, the bacterial chassis used in Synlogic’s
Synthetic Biotic approach is believed to stimulate the innate immune
system by several other mechanisms, including via Toll-like receptors,
potentially adding to the magnitude of the overall immune response. In
combination with atezolizumab, SYNB1891 has the potential to elicit both
innate and adaptive arms of the immune system to drive tumor reduction.

With an active IND, Synlogic plans to initiate an open-label,
multicenter Phase 1 clinical trial of SYNB1891 administered by
intra-tumoral (i.t.) injection to patients with advanced/metastatic
solid tumors. The primary objective of the study is to evaluate the
safety and tolerability of escalating doses of SYNB1891 to determine the
single-agent maximum tolerated dose (MTD) as monotherapy and the
recommended Phase 2 dose in combination with atezolizumab. In addition,
the study will explore immune biomarkers, objective response rates
(ORR), and time to progression for evaluated tumors. Synlogic will be
the sponsor of the study and Roche will provide clinical supply of
atezolizumab.

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 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 www.synlogictx.com.
Tecentriq^®
is a registered trademark of Hoffman-La Roche Ltd.

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, 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: inborn errors of metabolism, liver disease,
inflammatory and immune disorders, and cancer; 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 hyperammonemia,
phenylketonuria and cancer. 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
hereof.

Contacts

Synlogic
Media Contact:
Courtney Heath,
617-872-2462
[email protected]
or
Investor
Contact:
Elizabeth Wolffe, Ph.D., 617-207-5509
[email protected]