Full Press Release Details
Rockville, MD, Dec. 6, 2014 (GLOBE NEWSWIRE) -- December 6, 2014 -- 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
pre-clinical data for MGD011, a humanized CD19 x CD3 Dual-Affinity
Re-Targeting (DART ) protein, at the
56th Annual Meeting of the American Society of
Hematology (ASH), taking place in San Francisco, CA. These data
demonstrate potent T-cell mediated anti-tumor activity in
Liqin Liu, Ph.D., Senior Scientist at MacroGenics, presented a
poster titled: MGD011, Humanized CD19 x CD3 DART Protein with
Enhanced Pharmacokinetic Properties, Demonstrates Potent T-Cell
Mediated Anti-Tumor Activity in Preclinical Models and Durable
B-Cell Depletion in Cynomolgus Monkeys Following Once-a-Week
"CD19-targeted therapies have generated a great deal of
excitement and based on our pre-clinical data, we believe that
MGD011 has strong potential in the treatment of patients with
certain types of hematological malignancies," said Scott Koenig,
M.D., Ph.D., President and CEO of MacroGenics. "We are enthusiastic
about the initiation of clinical development in 2015."
Pre-Clinical Study Results with MGD011
The pre-clinical studies investigated the ability of MGD011 to
mediate anti-tumor activity. These studies demonstrated potent
anti-tumor activity in vitro and in mouse leukemia/lymphoma tumor
models, with high complete response rates and no evidence of
relapse over the study duration. MGD011, whose components
cross-react with the corresponding cynomolgus monkey antigens,
displayed prolonged pharmacokinetic properties in this species,
consistent with that of a monoclonal antibody. Treatment with
MGD011 induced durable, marked decrease in circulating B
lymphocytes and profound B-cell depletion in lymphoid organs in
cynomolgus monkeys following once-a-week dosing. MGD011 was well
tolerated at doses up to 100 mcg/kg, the highest dose tested, with
modest elevations in serum cytokines but no adverse findings. The
results of these pre-clinical studies provide a strong rationale
for the clinical development of MGD011 as a molecule for the
treatment of B-cell malignancies.
MGD011, a humanized CD19 x CD3 bispecific DART protein, is being
developed for the treatment of B-cell hematological malignancies.
CD19, a lymphocyte-specific marker expressed from early
B-lymphocyte development through mature memory B cells, is highly
represented in B-cell malignancies. This makes it attractive for
targeted interventions. MGD011 is designed to redirect T cells, via
their CD3 component, to eliminate CD19-expressing cells found in
many hematological malignancies. MGD011 has been engineered
to address half-life challenges posed by other programs targeting
CD19 and CD3. This product candidate has an Fc domain, which allows
for extended pharmacokinetic properties and convenient dosing at a
once-a-week or longer interval. In addition, MGD011 and the
Company's other DART molecules that redirect T cells against cancer
targets are manufactured using a conventional antibody platform
without the complexity of having to genetically modify T cells from
individual patients as required by approaches such as chimeric
antigen receptor (CAR) T-cells.
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 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 and DART are registered trademarks
of MacroGenics, Inc.
Cautionary Note on Forward-Looking
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
Company's strategy, future operations, clinical development of the
Company's therapeutic candidates, milestone or opt-in payments from
the Company's collaborators, the Company's future expectations and
plans and prospects and other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
uncertainties inherent in the initiation and enrollment of future
clinical trials, expectations of expanding ongoing clinical trials,
availability and timing of data from ongoing clinical trials,
expectations for regulatory approvals, other matters that could
affect the availability or commercial potential of the Company's
product candidates and other risk factors described in the
Company's filings with the Securities and Exchange Commission,
including those discussed in the "Risk Factors" section of the
Company's Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 20, 2014 and the subsequent Quarterly
Reports on Form 10-Q. In addition, the forward-looking statements
included in this press release represent the Company's views as of
the date hereof. The Company anticipates that subsequent events and
developments will cause the Company's views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements