Celgene and Agios Announce Collaborations with Abbott for Diagnostic Identification of IDH Mutations in AML
October 12 2016 - 7:30AM
Business Wire
Companion diagnostic technology to be utilized
with enasidenib (AG-221/CC-90007) and AG-120 development programs
for relapsed/refractory acute myeloid leukemia (AML)
Approximately 20% of AML patients have an IDH
mutation
Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals,
Inc. (NASDAQ:AGIO) today announced each company has entered into
collaboration agreements with Abbott (NYSE: ABT), a leader in
diagnostic technologies, to develop and commercialize companion
diagnostic tests on Abbott’s m2000 RealTime System to identify
isocitrate dehydrogenase (IDH) mutations in acute myeloid leukemia
(AML) patients. Celgene is currently developing enasidenib
(AG-221/CC-90007), an IDH2 mutant inhibitor, for the treatment of
patients with relapsed or refractory AML who have an IDH2 mutation.
Agios is developing AG-120, an IDH1 mutant inhibitor, for the
treatment of patients with relapsed or refractory AML who have an
IDH1 mutation.
IDH1 and IDH2 mutations occur in approximately 20% of AML
patients. An article published online this week in the journal
Leukemia (Medeiros, Leukemia 2016) concluded that advances in the
understanding of the genetics underlying myeloid malignancies are
driving an era of development for targeted treatments such as IDH
mutant inhibitors. The authors recommend that IDH mutational
analysis should become part of the routine AML diagnostic workup
and repeated at relapse to identify patients who may be eligible
for targeted investigational treatments currently under clinical
study.
“AML is a complex and heterogeneous disease, making it difficult
to treat,” said Han Myint, M.D., Vice President, Global Medical
Affairs, Myeloid for Celgene. “IDH mutations lead to aberrant DNA
methylation, causing a block in myeloid differentiation that leads
to disease progression. Molecular profiling is important to
identify genomic mutations which may have prognostic and potential
treatment implications for patients with AML.”
Abbott’s m2000rt RealTime System, is a polymerase chain reaction
(PCR) instrument designed to enable clinical laboratories to
automate PCR and results analysis, simplifying the complex and
manual steps often associated with molecular diagnostics. Both
Celgene and Agios have incorporated this screening into clinical
trial designs, including the recently initiated Phase 3 IDHENTIFY
trial comparing enasidenib with conventional therapy in older
patients with an IDH2 mutation and relapsed or refractory AML
(NCT02577406).
“The field of personalized medicine is advancing at a rapid pace
for a broad range of medical conditions, especially within
hematology-oncology,” said Chris Bowden, M.D., chief medical
officer at Agios. “Our collaboration with Abbott will provide a
test to help identify AML patients with IDH mutations who are in
need of treatment options.”
The m2000 system has not been FDA cleared or approved for use
with enasidenib or AG-120.
Enasidenib and AG-120 have not been approved for any use in any
country.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey,
is an integrated global biopharmaceutical company engaged primarily
in the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow
Celgene on Social
Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube.
About Agios
Agios is focused on discovering and developing novel
investigational medicines to treat cancer and rare genetic
metabolic disorders through scientific leadership in the field of
cellular metabolism. In addition to an active research and
discovery pipeline across both therapeutic areas, Agios has
multiple first-in-class investigational medicines in clinical
and/or preclinical development. All Agios programs focus on
genetically identified patient populations, leveraging our
knowledge of metabolism, biology and genomics. For more
information, please visit the company's website
at www.agios.com.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. Neither Celgene nor Agios undertake any obligation to update
any forward-looking statement in light of new information or future
events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which
are difficult to predict and are generally beyond each company’s
control. Actual results or outcomes may differ materially from
those implied by the forward-looking statements as a result of the
impact of a number of factors, many of which are discussed in more
detail in the Annual Report on Form 10-K and other reports of each
company filed with the Securities and Exchange Commission.
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version on businesswire.com: http://www.businesswire.com/news/home/20161012005676/en/
For
Celgene:Investors:908-673-9628investors@celgene.comorMedia:908-673-2275media@celgene.comorFor
Agios:Kendra Adams, 617-844-6407Senior Director, Investor
& Public RelationsKendra.Adams@agios.comorRenee Leck,
617-649-8299Senior Manager, Investor & Public
RelationsRenee.Leck@agios.com
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