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 positive results from SOPHIA, the
Company’s Phase 3 clinical study of margetuximab in HER2-positive
metastatic breast cancer patients. Margetuximab is an
investigational immune-enhancing monoclonal antibody derived from
the Company’s proprietary Fc Optimization technology platform. The
SOPHIA clinical trial met the primary endpoint of prolongation of
progression-free survival (PFS) in patients treated with the
combination of margetuximab plus chemotherapy compared to
trastuzumab plus chemotherapy. Patients in the margetuximab arm
experienced a 24% risk reduction in PFS compared to patients in the
trastuzumab arm (HR=0.76, p=0.033). Notably, approximately 85% of
patients in the study were carriers of the CD16A (FcγRIIIa) 158F
allele, which has been previously associated with diminished
clinical response to HERCEPTIN and other antibodies. In this
pre-specified subpopulation, patients in the margetuximab arm
experienced a 32% risk reduction in PFS compared to patients in the
trastuzumab arm (HR=0.68, p=0.005). Results of the SOPHIA study are
being prepared for submission for publication and presentation
later this year at a major scientific conference. Follow-up for
determination of the impact of therapy on the sequential primary
endpoint of overall survival (OS) is ongoing, as pre-specified in
the study protocol and recommended by the trial’s independent Data
Safety Monitoring Committee. MacroGenics anticipates submitting a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration in the second half of 2019.
The SOPHIA study enrolled 536 patients at approximately 200
trial sites across North America, Europe and Asia. Patients were
treated with either margetuximab or trastuzumab in combination with
one of four chemotherapy agents (capecitabine, eribulin,
gemcitabine or vinorelbine). All study patients had previously
received trastuzumab and pertuzumab, and approximately 90% had
previously received ado-trastuzumab emtansine. The combination of
margetuximab and chemotherapy demonstrated acceptable safety and
tolerability, comparable overall to that of trastuzumab and
chemotherapy.
“There are currently no approved agents for the treatment of
patients with metastatic HER2+ breast cancer who have previously
received trastuzumab, pertuzumab and ado-trastuzumab emtansine. If
margetuximab is approved, based on SOPHIA data, I believe that this
agent could become a valuable treatment option for these patients,”
said Hope S. Rugo, M.D., Director, Breast Oncology and Clinical
Trials Education, University of California San Francisco
Comprehensive Cancer Center.
“We are pleased with the SOPHIA clinical results and are
especially grateful to the patients, their caregivers, trial
investigators and site personnel who participated in the study. I
would also like to thank the entire MacroGenics team and our
business partners who worked diligently to bring margetuximab to
the clinic and execute the SOPHIA study,” said Scott Koenig, M.D.,
Ph.D., MacroGenics’ President and CEO. “Our Fc-engineered,
immune-enhanced molecule has demonstrated a superior outcome in a
head-to-head study against HERCEPTIN. We look forward to additional
opportunities to develop margetuximab in other HER2-positive breast
and gastric cancer populations.”
Conference Call Information
MacroGenics will host a conference call today at 8:30 AM
(ET) to discuss the results of the SOPHIA clinical study. To
participate in the conference call, please dial (877) 303-6253
(domestic) or (973) 409-9610 (international) five minutes prior to
the start of the call and provide the Conference ID: 7965575.
The recorded, listen-only webcast of the conference call can be
accessed under "Events & Presentations" in the Investor
Relations section of the Company's website at
http://ir.macrogenics.com/events.cfm. A replay of the webcast will
be available shortly after the conclusion of the call and archived
on the Company's website for 30 days following the call.
About Margetuximab
Margetuximab is an investigational monoclonal antibody that
targets the human epidermal growth factor receptor 2, or HER2
oncoprotein. HER2 is expressed by tumor cells in breast,
gastroesophageal and other solid tumors. Margetuximab was designed
to provide HER2 blockade and has been engineered with an Fc domain
to enhance the engagement of the immune system. In addition to
studying margetuximab in breast cancer, MacroGenics is developing
the antibody in combination with anti-PD-1 therapy to engage both
innate and adaptive immunity for the treatment of patients with
gastroesophageal cancer.
About MacroGenics’ Fc Optimization
Technology
MacroGenics’ Fc Optimization platform is designed to modulate an
antibody’s interaction with immune effector cells. The Fc region of
certain antibodies binds activating and inhibitory receptors,
referred to as FcγRs, on immune cells found within the innate
immune system. Such interactions affect killing of cancer cells
through antibody dependent cellular cytotoxicity (ADCC), among
other Fc-dependent functions.
Activating FcγRs occur in two variants, or alleles, with high
(158V) or low (158F) affinity for the Fc domain of IgG1. A majority
(approximately 85%) of the population carries the 158F allele,
either in the homozygous or heterozygous form with 158V. Patients
that carry the 158F allele have been reported to show diminished
clinical responses to certain therapeutic antibodies, including
HERCEPTIN.
MacroGenics’ optimized Fc region binds with increased affinity
to the activating FcγRs, including the 158F low-affinity allele,
and, unique to MacroGenics’ technology, with reduced affinity to
the inhibitory FcγR, resulting in improved effector functions, such
as ADCC. To date, MacroGenics has successfully incorporated its
proprietary Fc Optimization technology in margetuximab, as well as
enoblituzumab, an anti-B7-H3 monoclonal antibody currently in
development in combination with anti-PD-1 therapy for cancer
treatment.
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 and the MacroGenics logo 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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