Incyte’s Novel Mutant CALR Antibody Unveiled at ASH 2022 Plenary Scientific Session
December 11 2022 - 3:00PM
Business Wire
- INCA033989, a new anti-mutant calreticulin
(CALR)-targeted monoclonal antibody, represents important research
milestone in myelofibrosis (MF) and essential thrombocythemia
(ET)
- INCA033989 abstract selected as one of only
six ASH plenary presentations
- INCA033989 clinical trials to begin in
2023
- Research highlights Incyte’s discovery
capabilities and progress of its LIMBER program evaluating new
targets and combinations for patients with myeloproliferative
neoplasms (MPNs) and graft-versus-host disease (GVHD)
Incyte (Nasdaq:INCY) today announced new research detailing the
development and mechanism of action of INCA033989, an
Incyte-discovered, investigational novel anti-mutant calreticulin
(CALR)-targeted monoclonal antibody. Pre-clinical data indicate
that INCA033989 can alter disease course by reducing mutant CALR
allele burden and thus may be an efficacious and safe treatment in
patients with myelofibrosis (MF) and essential thrombocythemia
(ET). This research was featured in the Plenary Scientific Session
(Abstract #6. Session: Hematology Disease Topics & Pathways:
Research, Diseases, Therapies, Myeloid Malignancies) at the 64th
American Society of Hematology (ASH) Annual Meeting, held December
10-13, 2022, in New Orleans and virtually1.
“As a pioneer in the field of myeloproliferative neoplasms
(MPNs), having brought the first FDA-approved treatment to
patients, we are excited to have the opportunity to share details
of our latest research,” said Dash Dhanak, Ph.D., Executive Vice
President and Chief Scientific Officer, Incyte. “We continue to
apply our deep understanding of the complex biology of MPNs to
expand treatment options for patients and the work on INCA033989
presented today reflects our progress toward this goal. We look
forward to continuing to advance the development of this potential
new treatment and to initiating clinical trials for INCA033989 next
year.”
CALR mutations are responsible for disease development in
approximately 25-35%2,3 of patients with MF and ET – two common
types of MPNs. INCA033989 binds with high affinity to mutant CALR
and inhibits oncogenesis, the process of cells becoming cancerous,
in cells expressing this oncoprotein. As described in our
presentation, INCA033989 potently antagonizes CALR oncogenic
function, resulting in selective inhibition of JAK/STAT signaling
only in CALR-mutated cells with no effect on normal, non-oncogenic
cells. This selectivity of action with INCA033989 results in the
specific killing of tumor cells harboring the mutation and is
suggestive of the potential to alter the course of disease in
patients with CALR-mutant MF and ET.
“Diseases like myelofibrosis and essential thrombocythemia are
often difficult to understand and treat, and unique approaches are
necessary to develop effective and safe therapies,” said Srdan
Verstovsek, M.D., Ph.D., Professor of Medicine, Department of
Leukemia, University of Texas MD Anderson Cancer Center. “As a
leader in the field, Incyte is uniquely positioned to develop novel
medicines for these rare blood cancers, and this research provides
strong rationale for the continued investigation and clinical
advancement of INCA033989 – a novel treatment approach that targets
CALR mutations.”
More information regarding the congress and the more than 50
abstracts from Incyte’s oncology portfolio being featured at the
meeting is available on the ASH website:
https://www.hematology.org/meetings/annual-meeting.
About Myeloproliferative Neoplasms
Myeloproliferative neoplasms (MPNs) are a closely related group
of blood cancers in which the bone marrow functions abnormally. The
bone marrow is where the body’s blood cells are made. MPNs are
progressive blood cancers that can strike anyone at any age, but
they are more common in older adults. Estimates of the prevalence
of MPNs vary, but analysis of claims data suggests there may be as
many as 200,000 people in the U.S. living with the most prevalent
MPNs: myelofibrosis, polycythemia vera or essential
thrombocythemia4.
About LIMBER
Incyte is a leader in the discovery and development of therapies
for patients with myeloproliferative neoplasms (MPNs) and
graft-versus-host disease (GVHD). The Leadership In MPNs and GVHD
BEyond Ruxolitinib (LIMBER) program is designed to evaluate
multiple monotherapy and combination strategies to improve and
expand treatments for patients with MPNs and GVHD. The program
currently has three key areas of focus: development of a new,
once-daily formulation of ruxolitinib; ruxolitinib-based
combinations with new targets such as PI3Kδ, BET and ALK2; and new
therapeutic options such as mutant CALR.
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
regarding the presentation of data from Incyte’s clinical
development pipeline, whether or when any development compounds or
combinations will be approved or commercially available for use in
humans anywhere in the world outside of the already approved
indications in specific regions and Incyte’s goal of improving the
lives of patients, contain predictions, estimates and other
forward-looking statements.
These forward-looking statements are based on 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; the
effects of the COVID-19 pandemic and measures to address the
pandemic on Incyte and its partners’ clinical trials, supply chain,
other third-party providers and development and discovery
operations; determinations made by the U.S. FDA and other
regulatory authorities outside of the United States; the efficacy
or safety of Incyte and its partners’ products; the acceptance of
Incyte and its partners’ products in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; and other risks detailed from time to time in
Incyte’s reports filed with the Securities and Exchange Commission,
including its annual report and its quarterly report on Form 10-Q
for the quarter ended September 30, 2022. Incyte disclaims any
intent or obligation to update these forward-looking
statements.
_______________________________ 1 Reis E, et al. Discovery of
INCA033989, a Monoclonal Antibody That Selectively Antagonizes
Mutant Calreticulin Oncogenic Function in Myeloproliferative
Neoplasms. Presented at the 64 ASH Annual Meeting, December 10-13,
2022. 2 Nagalia et al. Somatic CALR mutations in myeloproliferative
neoplasms with nonmutated JAK2. N Engl J Med 2013; 369:2391-2405. 3
Klampfl T et al. Somatic Mutations of Calreticulin in
Myeloproliferative Neoplasms. N Engl J Med 2013; 369:2379-2390. 4
Data on file.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221211005037/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From May 2024 to Jun 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jun 2023 to Jun 2024