MONROVIA, Calif., Jan. 5, 2018 /PRNewswire/ -- Xencor, Inc.
(NASDAQ:XNCR), a clinical-stage biopharmaceutical company
developing engineered monoclonal antibodies for the treatment of
autoimmune disease, asthma and allergic diseases, and cancer, today
announced the company's 2018 priorities and expected clinical
development and research milestones.
"Xencor has long been committed to leveraging the plug-and-play
nature of our XmAb® Fc domains to develop a broad pipeline of
antibody therapeutics, and ultimately deliver new medicines to
patients with life-threatening and debilitating diseases," said
Bassil Dahiyat, Ph.D., president and
chief executive officer of Xencor. "In 2018, we will make important
strides toward achieving this vision. We expect several milestones
across the 11 wholly-owned and partnered XmAb antibody programs
currently in clinical development. Our lead internal program,
XmAb®5871, is expected to begin its first Phase 3 trial, joining
partnered programs ALXN1210 and MOR208 -- being developed by
Alexion and MorphoSys, respectively -- in late-stage development.
We also expect initial data from our Phase 2 trial of XmAb®5871 in
systemic lupus erythematosus (SLE)."
"Turning to our bispecific oncology pipeline, we look forward to
announcing first-in-human data for our two most advanced
candidates, XmAb®14045 and XmAb®13676. We also plan to expand our
clinical-stage bispecific pipeline in 2018, initiating Phase 1
trials of two programs and filing investigational new drug (IND)
applications for two others, both of which target the tumor
microenvironment. With a broad and prolific antibody engineering
platform and deep antibody drug development pipeline, we have a
number of robust catalysts ahead in 2018."
The Company's expected clinical development and research
milestones are outlined below.
XmAb5871: XmAb5871 is a first-in-class monoclonal
antibody that targets CD19 with its variable domain, and uses
Xencor's XmAb immune inhibitor Fc domain to target FcyRIIb, a
receptor that inhibits B-cell function. Final data from a Phase 2
trial in IgG4-Related Disease were presented in November 2017, and enrollment was completed in
the Phase 2 trial in SLE in December.
Expected milestones for XmAb5871 in IgG4-RD:
- Initiate Phase 3 trial in the second half of 2018. Following a
Type B End of Phase 2 meeting with the U.S. Food and Drug
Administration (FDA), Xencor expects this randomized,
placebo-controlled, double-blinded trial to evaluate the addition
of XmAb5871 to standard-of-care in approximately 250 to 350
patients with IgG4-RD.
- Seek scientific advice from the European Medicines Agency in
early 2018.
Expected milestones for XmAb5871 in SLE:
- Announce initial data from Phase 2 trial in the fourth quarter
of 2018.
Bispecific Oncology Pipeline: Xencor's initial
bispecific antibody programs are tumor-targeted antibodies that
contain both a tumor antigen binding domain and a cytotoxic T-cell
binding domain (CD3). These bispecific antibodies activate T cells
for highly potent and targeted killing of malignant cells. Their
XmAb Fc domains confer long circulating half-lives, stability and
ease of manufacture. Xencor is also expanding its bispecific
pipeline to include a suite of tumor microenvironment activators
that engage multiple targets, such as T-cell checkpoints or
agonists.
Expected milestones for tumor-targeted bispecific
antibodies:
- Announce initial data from Phase 1 study of XmAb14045 for the
treatment of AML and other CD123-expressing hematologic
malignancies in 2018, pending alignment on timing with
Novartis.
- Announce initial data from Phase 1 study of XmAb13676 for the
treatment of B-cell malignancies in 2018, pending alignment on
timing with Novartis.
- Initiate Phase 1 trial evaluating XmAb®18087 for the treatment
of neuroendocrine tumors and GIST in the first quarter of
2018.
Expected milestones for tumor microenvironment-targeting
bispecific antibodies:
- Initiate Phase 1 trial evaluating XmAb®20717, a PD-1 x CTLA-4
dual checkpoint inhibitor for the treatment of multiple oncology
indications in 2018.
- File IND for XmAb®22841, a CTLA-4 x LAG-3 dual checkpoint
inhibitor for the treatment of multiple oncology indications in
2018 and initiate a Phase 1 trial in 2019.
- File IND for XmAb®23104, a PD-1 x ICOS bispecific antibody for
the treatment of multiple oncology indications in 2018 and initiate
a Phase 1 trial in 2019.
XmAb®7195: XmAb7195 is a first-in-class monoclonal
antibody that targets IgE with its variable domain and uses
Xencor's XmAb immune inhibitor Fc domain to target FcyRIIb,
resulting in three distinct mechanisms of action for reducing IgE.
Data from the subcutaneous Phase 1b
study were announced in November 2017
and Xencor is currently seeking a development partner for
XmAb7195.
Pipeline Expansion: Xencor continues to apply the
XmAb platform to create new drug candidates and is focused on
developing additional bispecific molecules for the treatment of
cancer.
Expected milestones for pipeline expansion:
- File IND for IL-15/IL-15Ra candidate for the treatment of
multiple oncology indications in 2019;
- Create additional development candidates activating cytotoxic
T-cells against tumor antigens and targeting the tumor
microenvironment.
A slide presentation describing these research and development
goals and other information will be available on the Investor page
of the Company's website at www.xencor.com on Monday, January 8, 2018.
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 the quotation from Xencor's president
and chief executive officer, and statements related to expectations
relating to Xencor's financial expectations and business, the
timing and future results of Xencor's research and development
programs, the timing, results and expectations of clinical
development and research milestones, Xencor's 2018 priorities, and
the expansion of Xencor's pipeline. 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, including
without limitation Xencor's Annual Report on Form 10-K for the year
ended December 31, 2016. 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.