MONROVIA, Calif., Feb. 18, 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, today announced that investigators John H. Stone, M.D., Ph.D. from the
Massachusetts General Hospital, and Xin
Kai, Ph.D. from the Ragon Institute will present the
characterization of biomarker assays from Xencor's ongoing,
open-label, phase 2 study of XmAb®5871 in
IgG4-Related Disease (IgG4-RD) at the 3rd International Symposium
on IgG4-Related Diseases & Fibrosis, February 18, 2017 at 9:30
a.m. HST (11:30 a.m. PT). The
presentation is titled "XmAb5871: Mechanistic Considerations."
The investigators will present preliminary flow cytometry data
characterizing circulating immune cell levels in the initial
patients enrolled in the study. Xencor is studying biomarkers in
this trial to create tools to improve monitoring of the disease and
understanding of its molecular basis.
Flow cytometry methods were presented for measuring circulating
B cells, plasmablasts and CD4-positive T cells. A partial reduction
in B cells was observed and was consistent with previous clinical
experience with XmAb5871 presented at American College of
Rheumatology 2015 Annual Meeting. A rapid reduction of circulating
plasmablasts was seen following XmAb5871 treatment. Initial
development of methods to monitor CD4+ T cells was also presented.
No significant apoptosis of B cells or CD4 T cells was induced by
XmAb5871 therapy.
"We are exploring a number of biomarkers to better understand
the pathology of IgG4-RD, a newly defined disorder," said
Paul Foster, M.D., chief medical
officer of Xencor. "We are continuing these efforts to support our
advancing development program for XmAb5871."
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,
and demonstrated promising treatment effect in patients with
rheumatoid arthritis, as well as ex vivo results showing inhibition
of SLE patient B-cell activation and humoral immunity.
Complete data results from a Phase 1b/2a study of XmAb5871 in
patients with rheumatoid arthritis were presented at
the American College of Rheumatology 2015 Annual Meeting
as well as at the EULAR 2015 Annual Meeting. Ex vivo
studies of SLE patient B cells were published in Journal of
Immunology, 2011, 186(7):4223.
About IgG4-Related Disease
IgG4-Related Disease
(IgG4-RD) is a rare fibro-inflammatory autoimmune disorder that we
estimate impacts up to 40,000 patients in the United States. IgG4-RD affects multiple organ
systems and is characterized by a distinct microscopic appearance
of diseased organs, including the presence of IgG4-positive
plasmablast cells that is required for diagnosis. 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. John H.
Stone, M.D, MPH, director, clinical rheumatology at Massachusetts
General Hospital has developed and is validating the IgG4-RD
Responder Index, a proposed instrument to assess disease
activity.
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, 10 candidates engineered with Xencor's XmAb®
technology are in clinical development internally and with
partners. Xencor's internal programs include: XmAb5871 in
Phase 2 development for the treatment of IgG4-Related Disease, and
also for the treatment of Systemic Lupus Erythematosus; XmAb7195 in
Phase 1 development for the treatment of asthma and allergic
diseases; XmAb14045 in Phase 1 development for acute myeloid
leukemia; and XmAb13676 for B-cell malignancies and XmAb18087 for
the treatment of neuroendocrine tumors, both in pre-clinical
development. 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, Novo Nordisk
and Boehringer Ingelheim. For more information, please
visit www.xencor.com.
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SOURCE Xencor, Inc.