MONROVIA, Calif.–(BUSINESS WIRE)–Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company
developing engineered monoclonal antibodies for the treatment of cancer,
autoimmune diseases, asthma and allergic diseases, today announced the
U.S. Food and Drug Administration (FDA) has lifted the partial clinical
hold that was placed on the Phase 1 study of XmAb14045, a CD123 x CD3
bispecific antibody molecule being evaluated in patients with relapsed
or refractory acute myeloid leukemia and other CD123-expressing
hematologic malignancies. The decision follows discussion and agreement
with the FDA on amendments to the study protocol, including guidance on
the monitoring and clinical management of cytokine release syndrome.
“We are working with investigational sites to resume enrollment based on
the amended protocol, through which we have sought to enhance the safety
of patients participating in the study,” said Paul Foster, M.D., senior
vice president and chief medical officer at Xencor.
About XmAb®14045
XmAb14045 is a tumor-targeted antibody that contains both a CD123
binding domain and a cytotoxic T-cell binding domain (CD3) in a Phase 1
clinical trial for the treatment of acute myeloid leukemia (AML) and
other CD123-expressing hematologic malignancies. An XmAb®
Bispecific Fc domain serves as the scaffold for these two antigen
binding domains and confers long circulating half-life, stability and
ease of manufacture on XmAb14045. CD123 is highly expressed on AML cells
and leukemic stem cells, and it is associated with poorer prognosis in
AML patients. Engagement of CD3 by XmAb14045 activates T cells for
highly potent and targeted killing of CD123-expressing tumor cells.
About Xencor, Inc.
Xencor is a clinical-stage biopharmaceutical company developing
engineered monoclonal antibodies for the treatment of cancer, autoimmune
diseases, asthma and allergic diseases. Currently, 12 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
monoclonal antibodies resulting in new mechanisms of therapeutic action.
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, but not limited to, the
quotations from Xencor’s president and chief executive officer and any
expectations relating to Xencor’s financial expectations and business,
the timing and success of clinical trials, future product candidates,
Xencor’s research and development programs, partnering efforts and
capital requirements. 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. 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, 2018
as well as Xencor’s subsequent filings with the Securities and Exchange
Commission. All forward-looking statements are based on Xencor’s current
information and belief as well as assumptions made by Xencor. 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. 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.
Contacts
Charles Liles
626-737-8118
cliles@xencor.com
Media Contact
Jason I. Spark
Canale Communications
619-849-6005
jason@canalecomm.com