Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical
company developing engineered antibodies and cytokines for the
treatment of cancer and autoimmune diseases, today announced 2023
corporate priorities and provided multiple clinical development
updates.
Bassil Dahiyat, Ph.D., president and chief executive officer at
Xencor, said:
“The plug-and-play nature of Xencor’s XmAb® Fc domains and our
protein engineering expertise have enabled a broad portfolio of
bispecific antibody and engineered cytokine drug candidates in
oncology and autoimmune disease, as well as a multitude of
partnerships that continue to generate milestone payments and
ongoing royalties. We seek to address challenging areas of biology
with our drug candidates, testing them in early-phase clinical
trials to rapidly determine which we advance internally, partner or
terminate. In 2022 we advanced this strategy, presenting
encouraging clinical data from multiple programs, stopping internal
development of two programs, and expanding our clinical-stage
portfolio with two novel format bispecific antibodies.
“We are building on this momentum in 2023, progressing our
clinical portfolio internally and with our co-development partners,
including four bispecific antibody programs targeting solid tumors.
Later this year, we will add a third engineered cytokine program to
the clinic, following recent Phase 1 data for XmAb564, our
regulatory T-cell targeting IL-2-Fc for autoimmune disease. We plan
to present emerging clinical data as our programs advance and look
forward to important updates and milestones from several partner
programs throughout the year.”
Execute on development plans for XmAb bispecific antibody and
cytokine programs in oncology
Plamotamab (CD20 x CD3), for B-cell
malignancies
Xencor is co-developing plamotamab with Janssen Biotech, Inc.
Xencor presented updated Phase 1 expansion cohort data for
intravenously administered plamotamab in December 2022. In the
fourth quarter of 2022, Xencor began dosing patients with
subcutaneously administered plamotamab. Separately, the Company is
winding down and ending enrollment in the Phase 2 study evaluating
intravenous plamotamab in combination with tafasitamab and
lenalidomide, in patients with relapsed or refractory diffuse large
B-cell lymphoma, due to challenges with patient accrual in
lymphoma. Xencor plans to:
- Advance chemotherapy-free treatment options for patients with
lymphoma, and in collaboration with Janssen scientists, Xencor is
developing B-cell targeted, co-stimulatory CD28 bispecific
antibodies to selectively enhance T-cell cytotoxic activity in
combination with plamotamab.
- Continue enrolling patients into the Phase 1 subcutaneous dose
escalation study.
Vudalimab (PD-1 x CTLA-4), designed to
activate intra-tumoral T cells
Xencor is advancing vudalimab, a selective dual checkpoint
inhibitor, in multiple Phase 2 clinical studies. Initial Phase 2
combination data in patients with metastatic castration-resistant
prostate cancer (mCRPC) were presented in November 2022. Xencor is
also conducting a Phase 2 monotherapy study in patients with
advanced gynecologic tumors and clinically defined high-risk mCRPC.
Xencor plans to:
- Continue enrolling patients into the two Phase 2 clinical
studies of vudalimab.
XmAb306, potency-reduced IL15/IL15Rα-Fc
fusion protein
Xencor is co-developing XmAb306 in collaboration with Genentech,
a member of the Roche Group. Genentech is conducting a Phase 1
study of XmAb306 as a single agent and in combination with
atezolizumab in patients with advanced solid tumors. Genentech is
also conducting two additional Phase 1 studies, evaluating XmAb306
in patients with relapsed/refractory multiple myeloma, either in
combination with daratumumab (anti-CD38 antibody) or in combination
with cevostamab (FcRH5 x CD3 bispecific antibody). Xencor plans
to:
- Support enrollment into clinical studies in combination with
other agents.
XmAb104 (PD-1 x ICOS), designed to
activate intra-tumoral T cells
A Phase 1 study is evaluating XmAb104 with or without the
anti-CTLA4 antibody ipilimumab, as CTLA-4 blockade has been found
to increase the frequency of ICOS-expressing T cells in multiple
solid tumors. Initial data reported in 2022 indicated XmAb104 was
well tolerated and exhibited a distinct safety profile compared to
other clinical-stage ICOS programs. Xencor plans to:
- Continue enrolling patients into the expansion portion of the
Phase 1 clinical study.
XmAb819 (ENPP3 x CD3), XmAb 2+1 bispecific
antibody for renal cell carcinoma (RCC)
XmAb819 uses Xencor’s XmAb 2+1 bispecific antibody format for
greater selectivity of ENPP3-expressing tumor cells compared to
normal cells, which express lower levels of ENPP3. Xencor plans
to:
- Continue enrolling patients into the Phase 1 dose-escalation
study in patients with RCC.
XmAb808 (B7-H3 x CD28), tumor-selective,
co-stimulatory CD28 bispecific antibody
CD28 is a key immune co-stimulatory receptor on T cells;
however, the ligands that activate T cells through CD28 are usually
not expressed on tumor cells. Targeted CD28 bispecific antibodies
may provide conditional co-stimulation of T cells, for example, to
T cells recognizing neoantigens or in concert with CD3 T-cell
engaging bispecific antibodies. XmAb808 targets the broadly
expressed tumor antigen B7-H3. Xencor plans to:
- Continue enrolling patients into the Phase 1 dose-escalation
study in patients with advanced solid tumors. The first patient was
dosed in the fourth quarter of 2022.
XmAb662, potency-reduced IL12-Fc fusion
protein designed to increase tumor immunogenicity
IL-12 is a potent pro-inflammatory cytokine that promotes high
levels of interferon gamma secretion from T-cells and NK cells,
increasing their cytotoxicity and the immunogenicity of the tumor
microenvironment by making tumor antigens more visible to the
immune system. Xencor plans to:
- Initiate a Phase 1 study in patients with advanced solid tumors
in mid-2023.
XmAb541 (Claudin-6 x CD3), XmAb 2+1
bispecific antibody for ovarian cancer
Claudin-6 (CLDN6) is a tumor-associated antigen overexpressed in
ovarian cancer and other solid tumors, and its differential
expression in cancerous tissue makes CLDN6 an intriguing target for
CD3 bispecific antibodies. Many members of the claudin family,
which are small transmembrane proteins, have high sequence
identity, complicating the design of antibodies selective among
claudins. XmAb541 was engineered with the XmAb 2+1 bispecific
antibody format, and the tumor binding domain was further
engineered for improved selectivity of CLDN6 over similar claudin
family members, such as CLDN9. Xencor plans to:
- Submit an investigational new drug application (IND) in
2023.
Explore the clinical potential of XmAb564, a wholly owned
IL2-Fc cytokine fusion targeting regulatory T cells in autoimmune
disease
XmAb564 is a potency-reduced, monovalent interleukin-2 Fc
(IL-2-Fc) fusion protein, designed to selectively activate and
expand regulatory T cells (Tregs) for the potential treatment of
patients with autoimmune diseases. In November 2022, Xencor
presented data from a Phase 1a single-ascending dose study in
healthy volunteers, demonstrating that a single dose was well
tolerated and generates durable, dose-dependent and selective
expansion of Tregs. Xencor plans to:
- Continue enrolling patients into the Phase 1b,
multiple-ascending dose study in patients with atopic dermatitis
and psoriasis.
Cash Position and Financial Guidance
Xencor’s broad development portfolio is supported by a strong
financial position. Xencor ended the fourth quarter of 2022 with
unaudited cash, cash equivalents, receivables and marketable debt
securities totaling approximately $610 million. Based on current
operating plans, Xencor expects to have sufficient cash resources
to fund research and development programs and operations through
the end of 2025.
About Xencor
Xencor is a clinical-stage biopharmaceutical company developing
engineered antibodies and cytokines for the treatment of patients
with cancer and autoimmune diseases. More than 20 candidates
engineered with Xencor's XmAb® technology are in clinical
development, and three XmAb medicines are marketed by partners.
Xencor's XmAb engineering technology enables small changes to a
protein's structure that result 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 the 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 statements regarding future IND
submissions, plans to initiate, terminate or enroll patients in
clinical trials, the quotations from Xencor's president and chief
executive officer, 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, including the ability of publicly disclosed preliminary
clinical trial data to support continued clinical development and
regulatory approval for specific treatments, in each case as
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, 2021 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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version on businesswire.com: https://www.businesswire.com/news/home/20230109005267/en/
For Investors: Charles Liles cliles@xencor.com 626-737-8118
For Media: Jason I. Spark Evoke Canale
jason.spark@evokegroup.com 619-849-6005
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