Incyte & Foundation Medicine Announce Agreement to Develop Companion Diagnostic for Pemigatinib (INCB54828), a Selective FGFR...
September 11 2018 - 7:30AM
Business Wire
Incyte Corporation (NASDAQ:INCY) and Foundation Medicine, Inc.,
today announced that the companies have entered into an agreement
for the development, regulatory support and commercialization of
companion diagnostics (CDx), with an initial focus on CDx
development for pemigatinib (INCB54828), Incyte’s selective
FGFR1/2/3 inhibitor, in patients with cholangiocarcinoma. The
initial CDx, which will include detection of activating FGFR2
translocations, is expected to be incorporated into
FoundationOne®CDx, Foundation Medicine’s FDA-approved comprehensive
genomic profiling (CGP) assay and broad CDx platform.
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Foundation Medicine
“There is an urgent need for a novel, biomarker-based, targeted
therapeutic approach for patients with cholangiocarcinoma. The
initial goal of this collaboration is to develop a companion
diagnostic to enable testing at diagnosis of stage IV disease, with
the aim of helping to reduce morbidity and mortality, and we are
very pleased to be working with Foundation Medicine as we seek to
improve outcomes for these patients,” said Steven Stein, M.D.,
Chief Medical Officer, Incyte. “Incyte is evaluating pemigatinib in
patients with cholangiocarcinoma as part of the FIGHT clinical
development program; initial data have been accepted for
presentation at the European Society of Medical Oncology meeting in
Munich this October.”
“We’re committed to helping our biopharma partners bring
biomarker-driven therapies to cancer patients. Partnerships with
innovative biopharma companies, such as Incyte, who leverage our
FDA-approved platform to help accelerate companion diagnostics
development, are essential to achieving this mission,” said Melanie
Nallicheri, Chief Business Officer and Head of Biopharma at
Foundation Medicine. “We’re proud to partner with Incyte to advance
development of a potential new precision oncology treatment option
for cholangiocarcinoma.”
About FGFR and Pemigatinib (INCB54828)
Fibroblast growth factor receptors (FGFRs) play an important
role in tumor cell proliferation and survival, migration and
angiogenesis (the formation of new blood vessels). Activating
mutations, translocations and gene amplifications in FGFRs are
closely correlated with the development of various cancers.
Pemigatinib is a potent, selective, oral inhibitor of FGFR
isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated
selective pharmacologic activity against cancer cells with FGFR
alterations. Phase 2 studies investigating the safety and efficacy
of pemigatinib monotherapy across several FGFR-driven malignancies
are ongoing—the FIGHT (FIbroblast Growth factor receptor in
oncology and Hematology Trials) clinical trial program currently
comprises FIGHT-201 in patients with metastatic or surgically
unresectable bladder cancer, including with activating FGFR3
alterations; FIGHT-202 in patients with metastatic or surgically
unresectable cholangiocarcinoma who have failed previous therapy,
including with activating FGFR2 translocations; and FIGHT-203 in
patients with myeloproliferative neoplasms with activating FGFR1
translocations.
About FoundationOne®CDx
FoundationOne®CDx is a next generation, sequencing based in
vitro diagnostic device for detection of substitutions, insertion
and deletion alterations (indels), and copy number alterations
(CNAs) in 324 genes and select gene rearrangements, as well as
genomic signatures including microsatellite instability (MSI) and
tumor mutational burden (TMB) using DNA isolated from
formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
FoundationOne CDx is intended as a companion diagnostic to identify
patients who may benefit from treatment with certain targeted
therapies in accordance with their approved therapeutic product
labeling. Additionally, FoundationOne CDx is intended to provide
tumor mutation profiling to be used by qualified health care
professionals in accordance with professional guidelines in
oncology for patients with solid malignant neoplasms.
For a full list of targeted therapies for which FoundationOne
CDx is indicated as a companion diagnostic, please visit
http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based
biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit the Company’s website at
www.incyte.com.
Follow @Incyte on Twitter
at https://twitter.com/Incyte.
About Foundation Medicine
Foundation Medicine is a molecular information company dedicated
to a transformation in cancer care in which treatment is informed
by a deep understanding of the genomic changes that contribute to
each patient's unique cancer. The company offers a full suite of
comprehensive genomic profiling tests to identify the molecular
alterations in a patient's cancer and match them with relevant
targeted therapies, immunotherapies and clinical trials. Foundation
Medicine’s molecular information platform aims to improve
day-to-day care for patients by serving the needs of clinicians,
academic researchers and drug developers to help advance the
science of molecular medicine in cancer.
For more information, please visit
http://www.FoundationMedicine.com or follow Foundation Medicine on
Twitter (@FoundationATCG).
Foundation Medicine® and FoundationOne® are registered
trademarks of Foundation Medicine, Inc.
Forward-Looking Statement of Incyte Corporation
Except for the historical information set forth herein, the
matters set forth in this release contain predictions, estimates
and other forward-looking statements, including without limitation
statements regarding a collaboration between Incyte and Foundation
Medicine, whether the companion diagnostic will enable testing at
diagnosis of stage IV cholangiocarcinoma or help reduce morbidity
and mortality, and the expected timing to report data from Incyte’s
INCB54828 study. 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; determinations made by the FDA;
Incyte’s dependence on its relationships with its collaboration
partners; and other risks detailed from time to time in Incyte’s
reports filed with the Securities and Exchange Commission,
including its Form 10-Q for the quarter ended June 30, 2018. Incyte
disclaims any intent or obligation to update these forward-looking
statements.
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Incyte CorporationMediaCatalina Loveman,
+1-302-498-6171orInvestorsMichael Booth, DPhil,
+1-302-498-5914orFoundation MedicineMediaLee-Ann
Murphy, +1-617-245-3077
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