Incyte (NASDAQ:INCY) and InnoCare (HKEX: 09969) today announced
that Incyte and a subsidiary of InnoCare have entered into a
collaboration and license agreement for the development and
commercialization of tafasitamab, a humanized Fc-modified cytolytic
CD19 targeting monoclonal antibody, in Greater China.
Under the terms of the agreement, InnoCare will pay Incyte US$35
million up front, and Incyte is eligible to receive up to an
additional US$82.5 million in potential development, regulatory and
commercial milestones, as well as tiered royalties.
InnoCare will receive the rights to develop and exclusively
commercialize tafasitamab in hematology and oncology in mainland
China, Hong Kong, Macau and Taiwan.
“The collaboration with InnoCare allows us to accelerate the
expansion of our partnered portfolio in China,” said Hervé
Hoppenot, Chief Executive Officer, Incyte. “We believe InnoCare
will be an excellent partner to accelerate the development of
tafasitamab, and if approved, help bring this innovative therapy to
patients and healthcare providers in Greater China.”
“We are honored and excited to partner with Incyte, and are
committed to making tafasitamab, an FDA-approved treatment,
available to eligible patients in Greater China, upon approval. The
strategic collaboration with Incyte will not only enhance our
strength in the field of hematology and oncology, but also offer us
good opportunity to explore the potential clinical benefit of our
BTK inhibitor orelabrutinib in combination with tafasitamab,” said
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare. “In
addition, we believe that tafasitamab, an innovative CD19 antibody,
is critical to solidifying our long-term strategy to strengthen our
large molecule capabilities and to enhance combinational therapies
with our existing pipelines.”
The transaction is effective immediately upon the execution of
the collaboration and license agreement.
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.
In June 2021, the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) issued a positive opinion
recommending the conditional marketing authorization of tafasitamab
in combination with lenalidomide, followed by tafasitamab
monotherapy, for the treatment of adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) who are not
eligible for autologous stem cell transplantation (ASCT). The CHMP
opinion is currently being reviewed by the European Commission,
which has the authority to grant marketing authorization for
medicinal products in the European Union (EU).
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 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.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company
committed to discovering, developing, and commercializing
first-in-class and/or best-in-class drugs for the treatment of
cancer and autoimmune diseases. We strategically focus on lymphoma,
solid tumors, and autoimmune diseases with high unmet medical needs
in China and worldwide. InnoCare has branches in Beijing, Nanjing,
Shanghai, Guangzhou, New Jersey and Boston.
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding whether and when tafasitamab will be approved for use in
Greater China or elsewhere; whether and when InnoCare will bring
tafasitamab to market in Greater China; the potential of
tafasitamab to treat patients with relapsed or refractory DLBCL or
for any other indication; the potential for Incyte to receive
royalties and payments from InnoCare for development, regulatory
and commercial milestones; and the potential for Incyte to broaden
its ability to bring new medicines to cancer patients in Asia and
elsewhere, contain predications, estimates and other
forward-looking statements.
These forward-looking statements are based on the Company's
current expectations and are 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; the effects of the COVID-19 pandemic and measures to
address the pandemic on the Company’s clinical trials, supply
chain, other third-party providers and development and discovery
operations; determinations made by regulatory authorities; the
Company’s dependence on its relationships with its collaboration
partners; the efficacy or safety of the Company’s products and the
products of the Company’s collaboration partners; the acceptance of
the Company’s products and the products of the Company’s
collaboration partners in the marketplace; market competition;
sales, marketing, manufacturing and distribution requirements; and
other risks detailed from time to time in the Company’s reports
filed with the Securities and Exchange Commission, including its
annual report for the year ended December 31, 2020, and the
quarterly report on Form 10-Q for the quarter ended June 30, 2021.
The Company disclaims any intent or obligation to update these
forward-looking statements.
InnoCare Forward-looking Statements
This report contains the disclosure of some forward-looking
statements. Except for statements of facts, all other statements
can be regarded as forward-looking statements, that is, about our
or our management's intentions, plans, beliefs, or expectations
that will or may occur in the future. Such statements are
assumptions and estimates made by our management based on its
experience and knowledge of historical trends, current conditions,
expected future development and other related factors. This
forward-looking statement does not guarantee future performance,
and actual results, development and business decisions may not
match the expectations of the forward-looking statement. Our
forward-looking statements are also subject to a large number of
risks and uncertainties, which may affect our short-term and
long-term performance.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210816005733/en/
Incyte Media Catalina
Loveman +1 302 498 6171 cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
InnoCare Media
Chunhua Lu 86+10-66609879 chunhua.lu@innocarepharma.com
Investors 86+10-66609999 ir@Innocarepharma.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jun 2024 to Jul 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jul 2023 to Jul 2024