Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Tr...
September 15 2020 - 8:00AM
Business Wire
-- Ongoing Clinical Program Includes the
Phase 3 ENHANCE Study in MDS --
-- Additional Studies Are Evaluating
Magrolimab in Both Hematologic and Solid Tumors --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
U.S. Food and Drug Administration (FDA) has granted Breakthrough
Therapy designation for magrolimab, a first-in-class,
investigational anti-CD47 monoclonal antibody for the treatment of
newly diagnosed myelodysplastic syndrome (MDS).
MDS is a type of cancer caused by poorly formed or dysfunctional
blood cells in the bone marrow. Approximately 15,000 people are
diagnosed with MDS in the U.S. each year, and no new treatments
have been approved in 14 years. The average survival rate for those
with lower-risk MDS is six years and approximately 18 months for
those with higher-risk MDS.
Breakthrough Therapy designation is designed to expedite the
development and regulatory review of investigational treatments for
serious or life-threatening conditions that, based on preliminary
clinical evidence, have the potential to substantially improve
clinical outcomes compared with available therapy.
The FDA granted Breakthrough Therapy designation for magrolimab
based on positive results of an ongoing Phase 1b study, which
evaluated magrolimab in combination with azacitidine in previously
untreated intermediate, high and very high-risk MDS. In data
presented at the 2020 European Hematology Society Congress, 91
percent of evaluable patients (n=33) treated with magrolimab plus
azacitidine achieved an objective response, with 42 percent
achieving a complete remission (CR). The combination of magrolimab
plus azacitidine was generally well-tolerated. No maximum tolerated
dose was reached and no MDS patients discontinued treatment due to
a treatment-related adverse event.
“The Breakthrough Therapy designation recognizes the potential
for magrolimab to help address a significant unmet medical need for
people with MDS and underscores the transformative potential of
Gilead’s immuno-oncology therapies in development,” said Merdad
Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
Magrolimab is currently being studied in the double-blind,
placebo-controlled, randomized Phase 3 ENHANCE trial in previously
untreated higher risk MDS. The trial will evaluate the safety and
efficacy of magrolimab, in combination with azacitidine, as
measured by CR and duration of CR.
Magrolimab is an investigational agent and has not been approved
anywhere globally. Its safety and efficacy have not been
established.
About Magrolimab
Magrolimab is a first-in-class investigational monoclonal
antibody against CD47 and macrophage checkpoint inhibitor that is
designed to interfere with recognition of CD47 by the SIRPα
receptor on macrophages, thus blocking the "don't eat me" signal
used by cancer cells to avoid being ingested by macrophages.
Magrolimab is being developed in several hematologic and solid
tumor malignancies, including MDS. Magrolimab has been granted Fast
Track Designation by the FDA for the treatment of MDS, acute
myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and
follicular lymphoma. Magrolimab has also been granted Orphan Drug
Designation by the FDA for MDS and AML and by the European
Medicines Agency for AML.
Additional information on magrolimab clinical trials is
available on www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
Gilead Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the risk that FDA and other regulatory agencies may not
approve magrolimab for the treatment of MDS and other indications,
and any marketing approvals, if granted, may have significant
limitations on its use. There is also the possibility of
unfavorable results from ongoing and additional clinical studies
involving magrolimab, including in combination with azacitidine,
and the possibility that Gilead may be unable to initiate and
complete future studies involving magrolimab in the anticipated
timelines or at all. Further, it is possible that Gilead may make a
strategic decision to discontinue development of magrolimab. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. These risks,
uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2020, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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Adam Levy, Investors (347) 446-1488 Marian Cutler, Media (973)
517-0519
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