Incyte Provides Update on Parsaclisib and MCLA-145
January 25 2022 - 4:30PM
Business Wire
Incyte (Nasdaq:INCY) today announced updates regarding the
clinical development of parsaclisib, the Company’s next-generation
oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), and
MCLA-145, its CD137/PD-L1 bispecific antibody co-developed under a
global collaboration and license agreement with Merus.
Incyte is withdrawing the New Drug Application (NDA) for
parsaclisib for the treatment of patients with relapsed or
refractory follicular lymphoma (FL), marginal zone lymphoma (MZL)
and mantle cell lymphoma (MCL). The decision to withdraw the NDA
follows discussions with U.S. Food and Drug Administration (FDA)
regarding confirmatory studies to support an accelerated approval,
which Incyte determined cannot be completed within a time period
that would support the investment. The withdrawal of the NDA is a
business decision and is not related to any changes in either the
efficacy or safety of parsaclisib. The decision impacts only the
FL, MZL and MCL indications in the U.S., and does not affect other
ongoing clinical trials in the U.S. or other countries.
Additionally, as part of its ongoing portfolio prioritization
and capital allocation review, Incyte has decided to opt-out of the
continued development of MCLA-145. Incyte will continue to
collaborate with Merus and leverage their platform to develop a
pipeline of novel agents.
About Parsaclisib
Parsaclisib is a potent, highly selective, next-generation
investigational novel oral inhibitor of phosphatidylinositol
3-kinase delta (PI3Kδ). It is currently under evaluation as a
monotherapy in several ongoing Phase 2 trials as a treatment for
non-Hodgkin lymphomas (follicular, marginal zone and mantle cell);
and in a Phase 3 study for autoimmune hemolytic anemia (AIHA).
Pivotal trials of parsaclisib in combination with ruxolitinib for
the treatment of patients with myelofibrosis are also underway.
In December 2018, Innovent and Incyte entered into a strategic
collaboration for three clinical-stage product candidates,
including parsaclisib. Under the terms of the agreement, Innovent
has received the rights to develop and commercialize parsaclisib
and two other assets in Mainland China, Hong Kong, Macau and
Taiwan.
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.
Forward Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements about
the potential of parsaclisib to provide a meaningful treatment for
patients with non-Hodgkin lymphomas (NHLs), the parsaclisib
development program generally and Incyte’s ongoing collaboration
with Merus and ability to leverage the Merus platform to develop a
pipeline of novel agents contain predictions, estimates and other
forward-looking statements.
These forward-looking statements are based on the Company’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 the FDA or other 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; 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, 2021. The Company 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/20220125006021/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Jenifer Antonacci +1 302 498 7036 jantonacci@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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