Xencor (NASDAQ: XNCR), MorphoSys AG (FSE: MOR; Prime Standard
Segment, MDAX & TecDAX; NASDAQ: MOR) and Incyte (NASDAQ: INCY)
today announced a clinical collaboration to investigate the
combination of tafasitamab, plamotamab and lenalidomide in patients
with relapsed or refractory diffuse large B-cell lymphoma (DLBCL),
first-line DLBCL, and relapsed or refractory follicular lymphoma
(FL).
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‟Xencor is pleased to partner with MorphoSys and Incyte to
advance the development of plamotamab, our CD20 x CD3 XmAb®
bispecific antibody that has demonstrated encouraging clinical
activity as a monotherapy in non-Hodgkin lymphoma,” said Bassil
Dahiyat, Ph.D., president and chief executive officer at Xencor.
“Plamotamab, which redirects T cells to tumors, and tafasitamab, a
CD19-directed XmAb antibody, combine powerful and distinct immune
pathways, and this collaboration is designed to enable us to
generate new clinical insights and accelerate development timelines
for patients who may need additional therapeutic options. It builds
upon many years of partnership between Xencor and MorphoSys
following MorphoSys’ in-licensing of tafasitamab in 2010.”
‟Tafasitamab in combination with lenalidomide is an important
new relapsed/refractory DLBCL treatment option for appropriate
patients in the United States today, and its mechanism of action,
efficacy and safety profile make it an attractive combination
partner,” said Jean-Paul Kress, M.D., chief executive officer of
MorphoSys. “We believe that tafasitamab as a backbone can add value
to new combinations such as with CD20 x CD3 bispecifics, and we are
excited about this collaboration with Xencor and Incyte aiming to
help more patients in areas of unmet need.”
‟This collaboration has the potential to advance patient care
and Incyte is proud to join Xencor and MorphoSys in evaluating this
new combination approach for these serious cancers,” said Hervé
Hoppenot, chief executive officer of Incyte.
Xencor’s plamotamab is a tumor-targeted bispecific antibody that
contains both a CD20 binding domain and a cytotoxic T-cell binding
domain (CD3). Tafasitamab is MorphoSys' CD19-directed antibody
which was recently approved by the U.S. Food and Drug
Administration in combination with lenalidomide for the treatment
of adult patients with relapsed or refractory DLBCL not otherwise
specified, including DLBCL arising from low grade lymphoma, and who
are not eligible for autologous stem cell transplant (ASCT). This
indication is approved under accelerated approval based on overall
response rate. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial(s).
Under the terms of the agreement, the companies plan to initiate
a Phase 1/2 study evaluating the combination of tafasitamab,
plamotamab and lenalidomide in patients with relapsed or refractory
DLBCL. Additionally, the companies are planning to evaluate the
combination in relapsed or refractory FL and first-line DLBCL in
multiple Phase 1b studies. MorphoSys and Incyte will provide
tafasitamab for the studies, which will be sponsored and funded by
Xencor and are planned to be conducted in North America, Europe and
Asia-Pacific.
The collaboration is effective immediately upon the execution of
the agreement.
About Plamotamab (XmAb®13676)
Plamotamab (XmAb®13676) is a tumor-targeted bispecific antibody
that contains both a CD20 binding domain and a cytotoxic T-cell
binding domain (CD3), which is currently in a Phase 1 clinical
study for the treatment of non-Hodgkin lymphoma (NHL) and chronic
lymphocytic leukemia (CLL). 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
plamotamab. CD20 is highly expressed on B-cell tumors, including
NHL and CLL. Engagement of CD3 by plamotamab activates T cells for
highly potent and targeted killing of CD20-expressing tumor
cells.
About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting
monoclonal antibody. In 2010, MorphoSys licensed exclusive
worldwide rights to develop and commercialize tafasitamab from
Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc
domain, which mediates B-cell lysis through apoptosis and immune
effector mechanism including antibody-dependent cell-mediated
cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis
(ADCP).
Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food
and Drug Administration in combination with lenalidomide for the
treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) not otherwise specified, including
DLBCL arising from low grade lymphoma, and who are not eligible for
autologous stem cell transplant (ASCT). This indication is approved
under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
In January 2020, MorphoSys and Incyte entered into a
collaboration and licensing agreement to further develop and
commercialize tafasitamab globally. Monjuvi is being
co-commercialized by Incyte and MorphoSys in the United States.
Incyte has exclusive commercialization rights outside the United
States.
A marketing authorization application (MAA) seeking the approval
of tafasitamab in combination with lenalidomide in the EU has been
validated by the European Medicines Agency (EMA) and is currently
under review for the treatment of adult patients with relapsed or
refractory DLBCL, including DLBCL arising from low grade lymphoma,
who are not candidates for ASCT.
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in a number of ongoing combination
trials.
Monjuvi® is a registered trademark of MorphoSys AG.
XmAb® is a registered trademark of Xencor, Inc.
About Xencor
Xencor is a clinical-stage biopharmaceutical company developing
engineered monoclonal antibodies for the treatment of cancer and
autoimmune diseases. Currently, 18 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.
About MorphoSys
MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage
biopharmaceutical company dedicated to the discovery, development
and commercialization of exceptional, innovative therapies for
patients suffering from serious diseases. The focus is on cancer.
Based on its leading expertise in antibody, protein and peptide
technologies, MorphoSys, together with its partners, has developed
and contributed to the development of more than 100 product
candidates, of which 27 are currently in clinical development. In
2017, Tremfya®, developed by Janssen Research & Development,
LLC and marketed by Janssen Biotech, Inc., for the treatment of
plaque psoriasis, became the first drug based on MorphoSys'
antibody technology to receive regulatory approval. In July 2020,
the U.S. Food and Drug Administration (FDA) granted accelerated
approval of MorphoSys' proprietary product Monjuvi®
(tafasitamab-cxix) in combination with lenalidomide in patients
with a certain type of lymphoma.
Headquartered near Munich, Germany, the MorphoSys group,
including the fully owned U.S. subsidiary MorphoSys US Inc., has
~500 employees. More information at www.morphosys.com or
www.morphosys-us.com.
Monjuvi® is a registered trademark of MorphoSys AG. Tremfya® is
a registered trademark of Janssen Biotech, Inc.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Xencor 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; the outcome of the collaboration with MorphoSys
and Incyte, including the ability of the collaboration to generate
new clinical insights, accelerate development timelines and advance
patient care; the ability of the proposed combination treatment to
improve response rates and address more patients in areas of unmet
need; and the timing and success of the Phase 1/2 study and
multiple Phase 1b studies contemplated by the agreement. 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, 2019 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 cautionary statement 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.
MorphoSys Forward-Looking Statements
This communication contains certain forward-looking statements
concerning the MorphoSys group of companies, including the
expectations regarding Monjuvi's ability to treat patients with
relapsed or refractory diffuse large B-cell lymphoma, the further
clinical development of tafasitamab-cxix, including ongoing
confirmatory trials, additional interactions with regulatory
authorities and expectations regarding future regulatory filings
and possible additional approvals for tafasitamab-cxix as well as
the commercial performance of Monjuvi. The words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "would," "could," "potential," "possible,"
"hope" and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. The forward-looking
statements contained herein represent the judgment of MorphoSys as
of the date of this release and involve known and unknown risks and
uncertainties, which might cause the actual results, financial
condition and liquidity, performance or achievements of MorphoSys,
or industry results, to be materially different from any historic
or future results, financial conditions and liquidity, performance
or achievements expressed or implied by such forward-looking
statements. In addition, even if MorphoSys' results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. Among the factors that may
result in differences are MorphoSys' expectations regarding risks
and uncertainties related to the impact of the COVID-19 pandemic to
MorphoSys' business, operations, strategy, goals and anticipated
milestones, including its ongoing and planned research activities,
ability to conduct ongoing and planned clinical trials, clinical
supply of current or future drug candidates, commercial supply of
current or future approved products, and launching, marketing and
selling current or future approved products, the global
collaboration and license agreement for tafasitamab, the further
clinical development of tafasitamab, including ongoing confirmatory
trials, and MorphoSys' ability to obtain and maintain requisite
regulatory approvals and to enroll patients in its planned clinical
trials, additional interactions with regulatory authorities and
expectations regarding future regulatory filings and possible
additional approvals for tafasitamab-cxix as well as the commercial
performance of Monjuvi, MorphoSys' reliance on collaborations with
third parties, estimating the commercial potential of its
development programs and other risks indicated in the risk factors
included in MorphoSys' Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission. Given these
uncertainties, the reader is advised not to place any undue
reliance on such forward-looking statements. These forward-looking
statements speak only as of the date of publication of this
document. MorphoSys expressly disclaims any obligation to update
any such forward-looking statements in this document to reflect any
change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is
based or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements,
unless specifically required by law or regulation.
Incyte Forward-looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding expectations regarding Monjuvi's ability to treat
patients with relapsed or refractory diffuse large B-cell lymphoma,
the further clinical development of tafasitamab-cxix, including
ongoing confirmatory trials, additional interactions with
regulatory authorities and expectations regarding future regulatory
filings and possible additional approvals for tafasitamab-cxix as
well as the commercial performance of Monjuvi, and the development
of tafasitamab-cxix in combination with plamotamab, contain
predictions, estimates and other forward-looking statements. These
forward-looking statements are based on the Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials;
determinations made by regulatory authorities; the efficacy or
safety of Incyte’s or its collaborators’ products; the acceptance
of Incyte’s products and the products of its collaboration partners
in the marketplace; market competition; sales, marketing,
manufacturing and distribution requirements; greater than expected
expenses; expenses relating to litigation or strategic activities;
and other risks detailed from time to time in the Company’s reports
filed with the Securities and Exchange Commission, including its
Form 10-Q for the quarter ended September 30, 2020. Incyte
disclaims any intent or obligation to update these forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20201111005844/en/
Xencor, Inc. Charles Liles
cliles@xencor.com
Jason I. Spark Canale Communications Tel: +1 619-849-6005
jason@canalecomm.com
MorphoSys AG Media
Contacts: Jeanette Bressi Director, US Communications Tel: +1
617-404-7816 jeanette.bressi@morphosys.com
Sophie Petersen Senior Specialist Tel: +49 (0)89 / 899 27 26033
sophie.petersen@morphosys.com
Investor Contact: Dr. Julia Neugebauer Director Tel: +49
(0)89 / 899 27 179 julia.neugebauer@morphosys.com
Incyte Corporation Catalina
Loveman Executive Director, Public Affairs Tel: +1 302 498 6171
cloveman@incyte.com
Dr. Michael Booth Division Vice President, Investor Relations
& Corporate Responsibility Tel: +1 302 498 5914
mbooth@incyte.com
Christine Chiou Senior Director, Investor Relations Tel: +1 302
274 4773 cchiou@incyte.com
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