Synlogic Expands Capabilities in Manufacturing with the Appointment of Head of Technical Operations and Establishment of In-house Production of Clinical Trial Material for its Synthetic BioticTM Medicines

From Startup Synlogic Tx

Link to Full Article:

– Good Manufacturing Process (GMP) infrastructure enables advancement
of clinical programs through early and mid-phase studies –
– Capabilities support production of both liquid and solid oral
formulations –
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Dec. 12, 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 appointment of
Antoine Awad as Head of Technical Operations, and the expansion of its
manufacturing capabilities to produce clinical trial material for
mid-stage studies of its oral and immuno-oncology programs, through
entry into an agreement to lease GMP clean-room space from the Azzur
Group, LLC.

“We are delighted to welcome Tony to Synlogic at this critical stage in
the Company’s development as we expand our manufacturing capabilities
enabling the production of high-quality, clinical trial material
in-house,” said Aoife Brennan, M.B., Ch. B., Synlogic’s president and
chief executive officer. “His expertise in biologics process sciences
and his operational experience in scaling processes from research to
commercial production will be invaluable as we enter this new phase of
manufacturing development. This new clean-room facility provides an
affordable and flexible option that maximizes control over our process
and timelines enabling us to move efficiently through clinical
development to bring our Synthetic Biotic medicines to patients.”

“Synlogic has an exciting drug-development platform and is applying the
rigor of pharmaceutical standards to bacterial therapeutics through
analytics and science-based processes,” said Mr. Awad. “ I look forward
to bringing my experience in biologics process development,
manufacturing and formulation to continue to expedite clinical
development of our Synthetic Biotic medicines.”

Mr. Awad, who has been serving as a consultant with Synlogic since
October 2018, will join the company full-time in mid-December and will
be responsible for upstream and downstream process development and
manufacturing of Synlogic’s Synthetic Biotic medicines. Prior to joining
Synlogic he served as senior vice president of operations and CMC and
head of manufacturing for Abpro Therapeutics, a private company focused
on the development of novel bi-specific antibodies for oncology.
Earlier, Mr. Awad held positions of increasing responsibility over a
ten-year period at Merrimack Pharmaceuticals. As Head of Manufacturing
and Process Sciences, he transitioned to Ipsen Bioscience to integrate
and lead the commercial site for production of ONYVIDE®, which Ipsen
S.A. acquired from Merrimack.

Synlogic has entered into a forty-four-month agreement with the Azzur
Group, a MA-based engineering and consulting group specializing in GMP
manufacturing solutions. Under the agreement, Synlogic will lease
clean-room space in Azzur’s Waltham facility that Synlogic staff will
use for manufacturing and formulation of GMP material for Synlogic’s
early clinical studies of its first immuno-oncology program,
intratumorally administered SYNB1891, and mid-stage studies of solid
formulations of its orally administered Synthetic Biotic medicines. In
addition to the use of Azzur’s facility, as part of the agreement, Azzur
will provide personnel and other resources as needed to support
activities, including project management, sampling, material
receipt/release, inventory control, training and general consulting for
the duration of Synlogic’s use of the facility.

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
INVESTOR CONTACT:Elizabeth Wolffe, Ph.D.Phone:
617-207-5509Email: liz@synlogictx.comMEDIA
CONTACT:Courtney HeathPhone: 617-872-2462Email:

Please visit their site for more information: Synlogic

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2018-12-13 04:53:49