MacroGenics Advances Two First-in-Class Clinical DART® Molecules
September 05 2017 - 4:30PM
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 advancement of two of its proprietary
bispecific DART product candidates. This progress includes: a first
patient has been dosed with MGD013, a DART molecule that recognizes
PD-1 and LAG-3; and the submission of an Investigational New Drug
(IND) application with the FDA for MGD014, a DART molecule that
targets HIV-infected cells and CD3. MacroGenics retains worldwide
rights to both of these product candidates.
MGD013 recognizes both PD-1 and LAG-3 and was designed to enable
the co-blockade of these two immune checkpoint molecules
co-expressed on T cells. MGD013 has a prolonged serum half-life and
is being developed for the potential treatment of a wide range of
cancers, including both solid tumors and hematological
malignancies. MGD013 is MacroGenics’ first in a series of product
candidates that recognize multiple immune regulator targets as a
single recombinant molecule.
MGD014 is a bispecific, Fc-bearing DART molecule that targets
HIV-infected cells and CD3-expressing T cells, and is being
developed by MacroGenics under a contract awarded in September 2015
by the National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health. NIAID
recently notified MacroGenics that it was exercising the first of
two options under the HIV contract, funding MacroGenics’
advancement of MGD014 into Phase 1 clinical trials as well as the
development and testing of a second DART molecule. Under the
exercised option, funding of up to $10.8 million is available to
MacroGenics for these development efforts. The second option, if
later exercised by NIAID, would provide up to an additional $6.3
million for continued development efforts on one or both molecules.
Assuming MGD014 IND clearance by the FDA, the Company believes this
molecule will be the first clinical bispecific molecule targeting
an infectious agent.
“MacroGenics continues to progress its clinical pipeline, and
with the recent advancement of MGD013 and MGD014, there are
multiple DART molecules being tested in the clinic across multiple
modalities and therapeutic areas,” said Scott Koenig, M.D., Ph.D.,
President and Chief Executive Officer of MacroGenics.
Background on Bispecific DART Platform
MacroGenics' DART platform enables the targeting of multiple
antigens or cells by using a single molecule with an antibody-like
structure. The Company has created over 100 DART molecules which
have been configured for the potential treatment of cancer,
autoimmune disorders and infectious disease. These DART molecules
can be tailored for either short or prolonged pharmacokinetics and
have demonstrated good stability and attractive
manufacturability.
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.
The development of MGD014 is funded in part by NIAID under
contract no. HHSN272201500032C.
Cautionary Note on Forward-Looking
Statements
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 anticipated milestones
and future expectations and plans and prospects for the Company and
other statements containing the words "subject to", "believe",
"anticipate", "plan", "expect", "intend", "estimate", "project",
"may", "will", "should", "would", "could", "can", the negatives
thereof, variations thereon and similar expressions, or by
discussions of strategy constitute forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. 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 risks described in the Company's
filings with the Securities and Exchange Commission. In addition,
the forward-looking statements included in this press release
represent the Company's views only 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, except as may be required by law. These forward-looking
statements should not be relied upon as representing the Company's
views as of any date subsequent to the date hereof.
###
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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