MONROVIA, Calif., May 11, 2017 /PRNewswire/ -- Xencor,
Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical
company developing engineered monoclonal antibodies for the
treatment of autoimmune diseases, asthma and allergic diseases and
cancer, announced today that XmAb®5871 has been granted orphan drug
designation by the U.S. Food and Drug Administration (FDA) for the
treatment of IgG4-Related Disease (IgG4-RD), a newly defined
fibro-inflammatory autoimmune disorder that is estimated to impact
up to 40,000 patients in the United
States.
"There currently are no approved therapies for IgG4-RD, an
immune-mediated condition responsible for fibro-inflammatory
lesions that can lead to irreversible damage to virtually any
organ," said Bassil Dahiyat, Ph.D.,
president and chief executive officer of Xencor. "New treatment
options are clearly needed, and we are diligently moving XmAb5871
forward in clinical development to fill this void. Preliminary data
from our Phase 2 study of XmAb5871 showed promising activity in
patients with IgG4-RD, and we are on track to complete the study
and report topline results by the end of this year. We are
also planning to engage the FDA later this year to discuss future
clinical trials and potential registration requirements in
IgG4-RD."
The FDA's Orphan Drug Designation program provides orphan status
to drugs defined as those intended for the safe and effective
treatment, diagnosis or prevention of rare diseases that affect
fewer than 200,000 people in the U.S. Orphan designation qualifies
the sponsor of the drug for certain development incentives,
including tax credits for qualified clinical testing, prescription
drug user fee exemptions and seven-year marketing exclusivity upon
FDA approval.
About XmAb®5871
XmAb®5871 is a
first-in-class monoclonal antibody that targets CD19 with its
variable domain and that uses Xencor's XmAb immune
inhibitor Fc domain to target FcγRIIb, a receptor that inhibits
B-cell function. XmAb5871 is the first drug candidate
that Xencor is aware of that targets FcγRIIb
inhibition. Xencor has demonstrated in multiple animal
models and in initial human clinical trials that XmAb5871 inhibits
B-cell function without destroying these important immune cells.
Preliminary Phase 2 data presented at the American College of
Rheumatology 2016 Annual Meeting showed that 82 percent of patients
who received XmAb5871 achieved an initial response to therapy
within 2 weeks of their first dose with responses deepening over
time.
About IgG4-Related Disease
IgG4-Related Disease (IgG4-RD) is a rare fibro-inflammatory
autoimmune disorder responsible for fibro-inflammatory lesions that
can lead to irreversible damage to virtually any organ. IgG4-RD is
estimated to impact up to 40,000 patients in the United States. The disease affects multiple
organ systems and is characterized by a distinct microscopic
appearance of diseased organs, including the presence of
IgG4-positive plasmablast cells. This objective diagnostic
criterion is atypical for autoimmune diseases and offers advantages
for accurately identifying patients. There are currently no
approved therapies for this newly recognized disorder and
corticosteroids are the current standard of care.
About Xencor, Inc.
Xencor is a clinical-stage
biopharmaceutical company developing engineered monoclonal
antibodies for the treatment of autoimmune diseases, asthma and
allergic diseases and cancer. Currently, 11 candidates engineered
with Xencor's XmAb® technology are in clinical
development internally and with
partners. Xencor's internal programs include: XmAb®5871
in Phase 2 development for the treatment of IgG4-Related Disease,
and also for the treatment of Systemic Lupus Erythematosus;
XmAb®7195 in Phase 1 development for the treatment of asthma and
allergic diseases; XmAb®14045 in Phase 1 development for acute
myeloid leukemia; XmAb®13676 in Phase 1 development for B-cell
malignancies; XmAb®18087 in pre-clinical development for the
treatment of neuroendocrine tumors; and XmAb®20717 in pre-clinical
development for the treatment of multiple
cancers. Xencor's XmAb antibody engineering technology
enables small changes to the structure of monoclonal antibodies
resulting in new mechanisms of therapeutic
action. Xencor partners include Novartis, Amgen,
MorphoSys, Merck, CSL/Janssen, Alexion and Boehringer
Ingelheim. For more information, please
visit www.xencor.com.
Forward Looking Statements:
Statements contained in
this press release regarding matters that are not historical facts
are forward-looking statements within the meaning of applicable
securities laws, including any expectations relating to development
of XmAb®5871, timing of clinical study results and engagement with
FDA. Such statements involve known and unknown risks, uncertainties
and other factors that may cause actual results, performance or
achievements and the timing of events to be materially different
from those implied by such statements, and therefore these
statements should not be read as guarantees of future performance
or results. Such risks include, without limitation, the risks
associated with the process of discovering, developing,
manufacturing and commercializing drugs that are safe and effective
for use as human therapeutics and other risks described in Xencor's
public securities filings. All forward-looking statements are based
on Xencor's current information and belief as well as assumptions
made by Xencor. Readers are cautioned not to place undue reliance
on such statements and Xencor disclaims any intention or obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
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SOURCE Xencor, Inc.