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 clinical data from its ongoing
Phase 1 study of flotetuzumab in an oral session at the 59th Annual
Meeting of the American Society of Hematology (ASH) in Atlanta,
Georgia. John E. Godwin, M.D., Program Leader, Hematologic
Malignancies at Earle A. Chiles Research Institute at Providence
Cancer Center in Portland, Oregon presented "Preliminary Results of
a Phase 1 Study of Flotetuzumab, a CD123 x CD3 Bispecific DART
Protein, in Patients with Relapsed/Refractory Acute Myeloid
Leukemia and Myelodysplastic Syndrome."
The ongoing Phase 1, first-in-human study of flotetuzumab was
designed to determine safety, tolerability, maximum tolerated dose
and initial anti-leukemic activity in patients with relapsed or
refractory acute myeloid leukemia (AML) or intermediate-2/high risk
myelodysplastic syndrome (MDS). To date, a total of 57
patients have been enrolled, including 11 AML patients in the dose
expansion cohort.
Consistent with the dose escalation data that was previously
presented at ESMO Congress 2017 in September, flotetuzumab has
continued to demonstrate acceptable tolerability in patients
treated to date in the dose expansion cohort. Infusion-related
reaction and cytokine release syndrome (CRS) were the most common
adverse events observed, with Grade 3 CRS occurring in 9 of 57
patients (15.8%). Implementation of a two-step, lead-in dose as
well as early intervention with anti-cytokine therapy has helped to
limit the severity and incidence of CRS.
As of the data cut-off date, of the eight evaluable patients in
the dose expansion cohort who received a lead-in dose followed by
500 ng/kg/day of flotetuzumab via continuous IV infusion, six
patients (75%) have evidence of anti-leukemic activity, with three
of these patients experiencing an objective response. This included
two patients who experienced CR/CRi and one patient who achieved
MLF (morphologic leukemia-free state).
The duration of response for the eight patients who have
achieved a MLF, CRi or CR in the dose escalation and dose expansion
cohorts ranged from 1.0 to 5.8 months, with five of these responses
still ongoing as of the November 30, 2017 data cut-off.
Further, in a translational data poster presentation,
MacroGenics also described studies that support a rationale for
using checkpoint blockade as an approach to potentially enhance the
anti-leukemic activity of flotetuzumab. Among these findings,
modulation of the PD-1/PD-L1 pathway was observed in patients
treated with flotetuzumab, and the combination of flotetuzumab and
PD-1/PD-L1 inhibitors was shown to synergistically enhance T-cell
mediated cytotoxicity against AML cell lines in vitro.
"We continue to be encouraged by the tolerability and
anti-leukemic activity of flotetuzumab as well as by the early data
regarding the durability of responses observed in patients from our
ongoing Phase 1 study of flotetuzumab," said Scott Koenig, M.D.,
Ph.D., President and CEO of MacroGenics. "In addition, given the
data-supported rationale for combining flotetuzumab with anti-PD-1,
we intend to initiate a combination study with the anti-PD-1 mAb,
MGA012, in the coming months, while we continue to enroll the AML
and MDS dose expansion cohorts. We look forward to sharing
additional flotetuzumab clinical data in 2018.”
The presentation at the 59th Annual ASH meeting is available for
download from the Events & Presentations page on MacroGenics'
website at http://ir.macrogenics.com/events.cfm.
About Flotetuzumab
Flotetuzumab (also known as MGD006 and S80880) is a
clinical-stage molecule that recognizes both CD123 and CD3. CD123,
the Interleukin-3 receptor alpha chain, has been reported to be
over-expressed on cancer cells in a wide range of hematological
malignancies, including AML and MDS. The primary mechanism of
action of flotetuzumab is believed to be its ability to redirect T
lymphocytes to kill CD123-expressing cells. To achieve this, the
DART molecule combines a portion of an antibody recognizing CD3, an
activating molecule expressed by T cells, with an arm that
recognizes CD123 on the target cancer cells.
Flotetuzumab is currently being evaluated at 13 clinical sites
in the U.S. and Europe in a Phase 1 study designed to assess the
safety, tolerability, maximum tolerated dose and initial
anti-leukemic activity of the molecule in patients with
relapsed/refractory AML or intermediate-2/high risk MDS.
MacroGenics retains full development and commercialization rights
to flotetuzumab in the U.S., Canada, Mexico, Japan, South Korea and
India. Servier participates in the development of flotetuzumab and
has exclusive rights to this molecule in all other countries. The
U.S. Food and Drug Administration has granted orphan drug
designation to flotetuzumab for the treatment of AML.
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.
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.
###
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
MacroGenics (NASDAQ:MGNX)
Historical Stock Chart
From Aug 2024 to Sep 2024
MacroGenics (NASDAQ:MGNX)
Historical Stock Chart
From Sep 2023 to Sep 2024