MacroGenics Announces Partial Clinical Hold on MGD009 Phase 1 Studies
December 07 2018 - 04:01PM
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage
biopharmaceutical company focused on discovering and developing
innovative monoclonal antibody-based therapeutics for the treatment
of cancer, today announced that on December 6, it received a letter
from the U.S. Food and Drug Administration (FDA) indicating that a
partial clinical hold has been placed on its Phase 1 monotherapy
study of MGD009, a B7-H3 × CD3 bispecific DART® molecule, as well
as on a combination study of MGD009 and MGA012 (anti-PD-1). Under
the partial clinical hold, no new patients will be enrolled in
either study until the partial hold is lifted by the FDA. Current
study participants may continue to receive drug at their
pre-assigned dose.
The partial clinical hold was initiated following MacroGenics’
reporting of hepatic adverse events on the MGD009 monotherapy trial
to the FDA, including reversible elevations of transaminases with
or without concurrent elevations of bilirubin. Although these
events have been otherwise uncomplicated and short-lived in
duration, MacroGenics also communicated to the FDA the company’s
plans to amend the existing MGD009 studies with additional
supportive care to mitigate these events. The FDA has placed the
trials on partial clinical hold, pending review of additional
details regarding these events, and satisfactory review of the
planned amendments to the monotherapy and combination study
protocols and related documents. MacroGenics will be working
closely with the FDA to review these events and seek to resolve
this clinical hold.
“MacroGenics’ top concern in conducting clinical trials is the
safety of study participants,” said Scott Koenig, M.D., Ph.D. “As
we’ve identified to the FDA, we believe that transaminitis observed
in patients administered MGD009 was likely a cytokine-mediated
event. We are working with the FDA and will provide an update when
we have additional information. This partial clinical hold does not
impact ongoing clinical studies for enoblituzumab and MGC018, our
other B7-H3-targeted molecules.”
About MGD009
MGD009 is a humanized, bispecific DART molecule that recognizes
both B7-H3 and CD3 and has a prolonged serum half-life. B7-H3 is a
member of the B7 family of molecules involved in immune regulation
and is over-expressed on a wide variety of cancer cells, including
cancer stem cells, as well as on the supporting tumor vasculature
and underlying tissues, or stroma. The intended mechanism of action
of MGD009 is its ability to redirect T cells, via their CD3
component, to kill B7-H3-expressing cells.
In addition to MGD009, MacroGenics’ comprehensive B7-H3
franchise includes enoblituzumab, an Fc-optimized monoclonal
antibody, as well as MGC018, an antibody-drug conjugate (ADC).
These clinical molecules target B7-H3. MacroGenics retains
worldwide rights to its franchise of three B7-H3-based
molecules.
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. The
Company generates its pipeline of product candidates primarily from
its proprietary suite of next-generation antibody-based technology
platforms, which have applicability across broad therapeutic
domains. 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.
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
risk of delays or failure in reaching an agreement with the FDA
regarding the release of a clinical hold, 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.
###
Contacts:
Jim Karrels, Senior Vice President, CFO
MacroGenics, Inc.
1-301-251-5172, info@macrogenics.com
Karen Sharma, Managing Director
MacDougall Biomedical Communications
1-781-235-3060, ksharma@macbiocom.com
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