Xencor Doses First Subject in Phase 1 Study of XmAb®564, an Engineered IL-2 Cytokine in Development for Autoimmune Diseases
April 28 2021 - 4:01PM
Business Wire
Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical
company developing engineered monoclonal antibodies and cytokines
for the treatment of cancer and autoimmune diseases, today
announced that the first subject has been dosed in a randomized,
double-blind, placebo-controlled Phase 1 clinical study of XmAb564,
an engineered IL-2-Fc cytokine in development as a potential
treatment for patients with autoimmune diseases. The study will
evaluate the safety and tolerability of XmAb564, administered
subcutaneously in healthy adult volunteers.
Interleukin-2 (IL-2) is a signaling protein that activates and
expands certain immune cell populations, including regulatory T
cells (Tregs). Tregs prevent autoimmunity by suppressing other
immune cells from attacking normal tissue; however, in many
autoimmune diseases, Tregs become dysregulated. An existing
approach to restore normal immune activity and improve outcomes for
patients has been to activate Tregs with IL-2 provided
therapeutically at low doses. These regimens, however, suffer from
a narrow therapeutic window, because IL-2 is a highly potent
molecule that also activates the immune cell populations that Tregs
are intended to suppress.
"We engineered XmAb564 to selectively activate and expand
regulatory T cells over other immune cells by tuning the binding
affinities for both IL-2's alpha and beta receptors. Our modular
XmAb® heterodimeric Fc domain additionally provides XmAb564 with a
stable protein scaffold and improves its pharmacologic properties,
and we further enhanced circulating half-life by adding our Xtend™
Fc technology," said John Desjarlais, Ph.D., senior vice president
and chief scientific officer at Xencor. "In preclinical studies,
XmAb564 was well tolerated and promoted the selective and sustained
proliferation of Tregs over effector T cells and natural killer
(NK) cells."
"The goal of an IL-2 therapy for autoimmune disease is to
provide sustained low-intensity activation of Tregs while avoiding
the pro-inflammatory systemic activation of effector T cells," said
Allen Yang, M.D., Ph.D., senior vice president and chief medical
officer at Xencor. "An IL-2 therapy that is selective for Tregs,
with an expanded therapeutic window compared to other IL-2
approaches, would have broad potential across many different
autoimmune diseases."
The Phase 1 single ascending-dose study will characterize the
safety, tolerability and pharmacokinetics of XmAb564 in healthy
volunteers and will include an analysis of key immunomodulatory
biomarkers. For more information about the study, please visit
https://clinicaltrials.gov (Identifier: NCT04857866).
About XmAb®564
XmAb®564 is a monovalent interleukin-2 Fc (IL-2-Fc) fusion
protein, engineered to selectively activate and expand regulatory T
cells (Tregs) for the potential treatment of patients with
autoimmune diseases. XmAb564 is engineered with reduced binding
affinity for IL-2's beta receptor (IL-2Rβ, CD122) and increased
binding affinity for its alpha receptor (IL-2Rα, CD25). In
preclinical studies, XmAb564 was well-tolerated, promoted the
selective and sustained expansion of Tregs and exhibited a
favorable pharmacokinetic profile.
About Xencor, Inc.
Xencor is a clinical-stage biopharmaceutical company developing
engineered monoclonal antibodies and cytokines for the treatment of
cancer and autoimmune diseases. Currently, 21 candidates engineered
with Xencor's XmAb® technology are in clinical development
internally and with partners. Xencor's XmAb antibody engineering
technology enables small changes to the structure of proteins
resulting in new mechanisms of therapeutic action. For more
information, please visit www.xencor.com.
Forward-Looking Statements
Certain statements contained in this press release may
constitute forward-looking statements within the meaning of
applicable securities laws. Forward-looking statements include
statements that are not purely statements of historical fact, and
can generally be identified by our use of words such as
“potential,” “can,” “will,” “plan,” “may,” “could,” “would,”
“expect,” “anticipate,” “seek,” “look forward,” “believe,”
“committed,” “investigational,” and similar terms, or by express or
implied discussions relating to the development of XmAb564 as a
potential treatment for patients with autoimmune diseases; the
safety, tolerability, efficacy and pharmacokinetics of XmAb564; the
quotations from Xencor executives; and other statements that are
not purely statements of historical fact. Such statements are made
on the basis of the current beliefs, expectations, and assumptions
of the management of Xencor and are subject to significant 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. For a
discussion of these and other factors, please refer to Xencor's
annual report on Form 10-K for the year ended December 31, 2020 as
well as Xencor's subsequent filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof. This caution is made under the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995, as amended
to date. All forward-looking statements are qualified in their
entirety by this cautionary statement and Xencor undertakes no
obligation to revise or update this press release to reflect events
or circumstances after the date hereof, except as required by
law.
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Charles Liles cliles@xencor.com
Jason I. Spark Canale Communications 619-849-6005
jason@canalecomm.com
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