MacroGenics Presents Updated Data from Phase 1 Study of MGD010 at Annual European Congress of Rheumatology (EULAR 2017)
June 17 2017 - 2:15AM
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage
biopharmaceutical company focused on discovering and developing
innovative monoclonal antibody-based therapeutics for the treatment
of cancer, as well as autoimmune disorders and infectious diseases,
today announced the presentation of updated data from its Phase 1
study of MGD010 at the European League Against Rheumatism (EULAR)
Annual European Congress of Rheumatology in Madrid, Spain.
In a poster titled "Immunomodulatory Effects of MGD010, a DART®
Molecule Targeting Human B-cell CD32B and CD79B," the Company
highlighted the immunomodulatory impact of MGD010 on the response
to hepatitis A vaccination (HAV), a model antigen challenge, in
normal healthy subjects. These data demonstrate that by
pharmacologically exploiting the activity of the checkpoint
molecule CD32B in combination with the B-cell receptor (BCR) CD79B
component, a single dose administration of MGD010 at either 3 or 10
mg/kg delivers an immunomodulatory effect that counters B-cell
function.
In this portion of the Phase 1 study, 23 evaluable healthy
subjects received 3 or 10 mg/kg MGD010 or placebo, followed by HAV
immunization. There were no CTCAE grade 3 or higher adverse events
related to MGD010. Consistent with prior observations, ex vivo flow
cytometric analysis confirmed dose-dependent MGD010 binding to
peripheral B cells without B-cell depletion, accompanied by
decreased surface BCR and CD40 expression as well as a decrease in
total serum IgM levels. Compared to the placebo group, reduced HAV
seroconversion rates were observed in subjects treated with MGD010,
with significantly lower HA-specific IgG levels.
“The updated data regarding HAV seroconversion further confirm
that MGD010 can exert immunomodulatory activity in vivo consistent
with its intended mechanism of action. Combined with its good
safety profile, these results provide compelling rationale for
further development of this therapeutic modality for autoimmune
disorders,” said Scott Koenig, M.D., Ph.D., President and CEO of
MacroGenics.
The poster is available for download from the Events &
Presentations page on MacroGenics' website
at http://ir.macrogenics.com/events.cfm.
About MGD010
MGD010 is a humanized DART molecule that simultaneously targets
CD32B and CD79B. This product candidate is the first clinical
autoimmune-focused DART program. In normal conditions, B cells
utilize the checkpoint receptor, CD32B, as one of the key negative
regulators to ensure that tolerance to self is maintained and
autoimmune disorders do not occur. MGD010 exploits this mechanism
and triggers this immune checkpoint loop for the inhibition of
B-cell function, an approach that may be useful for the treatment
of patients with autoimmune disorders.
MacroGenics reported initial data from a Phase 1 study of MGD010
at EULAR 2016. The initial portion of this study was a
first-in-human, double-blind, placebo-controlled study in which a
single dose of MGD010 was intravenously (IV) administered to 49
healthy subjects. Data from the study showed that the molecule was
well tolerated at all dose levels and no serious adverse effects
were reported. None of the subjects participating in the study had
premature discontinuations or infusion reactions, systemic
hypersensitivity reactions or injection site reactions.
The data from this study demonstrated that MGD010 was well
tolerated as a single dose up to 10 mg/kg, with no evidence of
peripheral B-cell activation or depletion. Moreover, MGD010
exhibited: (1) linear pharmacokinetics with properties similar to
those of an antibody molecule, (2) dose-dependent B-cell occupancy
(with saturation >1 mg/kg), (3) down-modulation of BCR
expression among circulating memory and naïve B cells, (4)
downregulation of BCR-induced signaling and diminished propensity
for ex-vivo BCR-induced B-cell activation, (5) a decrease in
expression of the costimulatory CD40 molecule, and (6) a decrease
in circulating immunoglobulin M levels.
About MacroGenics, Inc.
MacroGenics is a clinical-stage biopharmaceutical company
focused on discovering and developing innovative monoclonal
antibody-based therapeutics for the treatment of cancer, as well as
autoimmune disorders and infectious diseases. The Company generates
its pipeline of product candidates primarily from its proprietary
suite of next-generation antibody-based technology platforms. The
combination of MacroGenics' technology platforms and protein
engineering expertise has allowed the Company to generate promising
product candidates and enter into several strategic collaborations
with global pharmaceutical and biotechnology companies. For more
information, please see the Company's website at
www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are
trademarks or registered trademarks of MacroGenics, Inc.
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CONTACTS:
Jim Karrels, Senior Vice President, CFO
MacroGenics, Inc.
1-301-251-5172, info@macrogenics.com
Karen Sharma, Senior Vice President
MacDougall Biomedical Communications
1-781-235-3060, ksharma@macbiocom.com
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