Syntimmune Closes $50 Million Series B Financing Led by Apple Tree Partners

NEW YORK–(BUSINESS WIRE)– Syntimmune, Inc., a clinical-stage biotechnology company focused on FcRn
biology, today announced a $50 million Series B financing led by Apple
Tree Partners, which has committed $48 million to the round, with
additional participation from other existing investors. Funds from the
Series B financing will further advance Syntimmune’s clinical
development program, which includes two ongoing Phase 1b/2a clinical
trials of the company’s lead drug candidate, SYNT001, in pemphigus and
warm autoimmune hemolytic anemia. SYNT001 is a monoclonal antibody that
blocks the FcRn-IgG interaction and is being developed for the treatment
of a broad variety of IgG-mediated autoimmune diseases.

Both warm autoimmune hemolytic anemia and pemphigus provide an
opportunity to address major unmet medical needs. These IgG-mediated
autoimmune diseases occur in distinct tissue compartments and illustrate
the broad potential utility and applicability of SYNT001 across the
spectrum of IgG-mediated diseases. This highly specific and
differentiated approach to blockade of IgG-mediated inflammation
preserves other key aspects of the immune system and is expected to
enable substantial improvement over current standards of care for these
devastating diseases.

The clinical and preclinical profile observed with SYNT001 through a US
Phase 1a trial showed safe and rapid onset of clinically
meaningful FcRn-IgG blockade, including that associated with
IgG-mediated innate and adaptive immune functions. In addition to
funding this broad clinical development campaign, the Series B proceeds
will be used to support manufacturing scale-up for SYNT001 in
preparation for anticipated registration studies. The funds will also
support further preclinical development of SYNT002, the company’s second
product candidate, as well as additional research activities.

“FcRn-targeted therapies have potential application to a broad range of
diseases for which there often are limited treatment options and few or
no FDA-approved therapies,” said Sam Hall, Ph.D., of Apple Tree
Partners. “The rapid clinical advances at Syntimmune have been
shepherded by a highly accomplished and experienced team and build upon
breakthrough translational science originating from the laboratory of
Richard Blumberg, M.D., Syntimmune’s scientific founder. We are excited
by this progress and look forward to the continued advancement of
SYNT001 through the company’s ongoing Phase 1b/2a studies and beyond.”

David de Graaf, Ph.D., Syntimmune’s president and chief executive
officer, said, “We are grateful for the continuing support of our
engaged investor syndicate. This funding will further increase the
momentum of our clinical development program. Based on this progress, we
anticipate announcing the first clinical data from our Phase 1b/2a
program and other translational research findings by early next year.
Syntimmune is poised to maintain its position as the leader in FcRn
biology as we plan for rapid expansion into pivotal studies and
additional indications.”

“Based on these clinical data, together with our preclinical research
findings, we are confident that SYNT001 can modulate the critical
aspects of FcRn-IgG biology. FcRn-IgG blockade with SYNT001 thus has the
potential to change the treatment paradigm of many IgG-mediated
autoimmune diseases.” said Laurence Blumberg, M.D., Syntimmune’s
business founder and chief operating officer.

Additional Details on the SYNT001 Clinical Development Program

SYNT001 Phase 1b/2a Study in Warm Autoimmune
Hemolytic Anemia (WAIHA)

Syntimmune has initiated a multicenter, open-label, safety,
tolerability, and activity Phase 1b/2a study of SYNT001 in individuals
with chronic, stable WAIHA. The study’s primary outcome measures are
safety and tolerability. Secondary measures include pharmacokinetics
(PK), pharmacodynamics (PD), immunogenicity, and effects on disease
activity markers. WAIHA is a rare blood disorder in which the immune
system produces antibodies that attack a patient’s own red blood cells,
the destruction of which can lead to severe, potentially debilitating
anemia. There are limited treatment options and no therapies currently
approved in their labeling to treat AIHA. For more information, please
visit clinicaltrials.gov.

SYNT001 Phase 1b/2a Study in Pemphigus

Syntimmune also has initiated a multicenter, open-label, safety,
tolerability, and activity Phase 1b/2a study of SYNT001 in subjects with
chronic pemphigus (vulgaris or foliaceus). The study’s primary outcome
measures are safety and tolerability. Secondary measures include PK, PD,
immunogenicity, and effects on disease activity markers. Pemphigus is
characterized by autoimmune blistering of the skin and mucous membranes;
in its more severe manifestations this disease can be highly
debilitating and potentially fatal. Many patients require long-term use
of corticosteroids and other immune system suppressors associated with
serious adverse events. For more information, please visit clinicaltrials.gov.

About Syntimmune

Founded in 2013 by Richard Blumberg, M.D., and Laurence Blumberg, M.D.,
Syntimmune is advancing novel therapies based on its leading position in
the biology of the neonatal Fc receptor (FcRn). As a core part of a
central common pathway that enables abnormal IgG responses, FcRn is a
well-validated target for the treatment of IgG-mediated autoimmune
diseases. Syntimmune’s lead candidate, SYNT001, is a monoclonal antibody
that specifically blocks FcRn-IgG interactions and is being studied in
multiple 1b/2a trials for the treatment of IgG-mediated autoimmune
diseases. In addition to SYNT001, Syntimmune is developing SYNT002,
which targets the interaction between FcRn and albumin and promotes
clearance of albumin-bound endo- and exotoxins. The Syntimmune team has
world-class experience in the field of FcRn biology and has successfully
pioneered and advanced biologics that engage FcRn. Since its founding,
the company has been funded with a total of $78 million in capital
commitments from leading life sciences investors, led by Apple Tree
Partners and including Partners Innovation Fund, FMB Research, and AFB
Fund. For more information on Syntimmune, please visit the company’s
website at www.syntimmune.com.

About Apple Tree Partners

Apple Tree Partners (ATP) is a New York-based venture capital firm
dedicated to building transformative life sciences businesses. The firm
is actively investing its fourth fund, with $1.5 billion in capital
commitments. ATP considers therapeutics and medical device investments
at all stages, from discovery research through to commercialization and
takes a long-term view to create sustainable value.

Learn more about ATP and its therapeutics portfolio at www.appletreepartners.com.

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