– Updated Data from IDHIFA® (Enasidenib) Phase 1
Trial in IDH2m R/R AML to be Presented in Oral Presentation;
Abstract Selected for Best of ASCO Program –
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields
of cancer metabolism and rare genetic diseases, today announced
that new data from its isocitrate dehydrogenase (IDH) programs will
be presented at the American Society of Clinical Oncology (ASCO)
Annual Meeting being held June 2-6, 2017 in Chicago.
In total, three abstracts led by Agios describing new data from
the company's IDH programs have been accepted for presentation at
ASCO, as well as two abstracts led by Celgene. IDHIFA® (enasidenib)
is being developed in collaboration with Celgene.
The accepted abstracts are listed below and are available online
on the ASCO conference website: http://abstracts.asco.org/.
Oral presentation by Agios and Celgene:
Title: Enasidenib in mutant-IDH2 relapsed or
refractory acute myeloid leukemia (R/R AML): Results of a phase 1
dose-escalation and expansion study Date &
Time: Tuesday, June 6, 2017 from 10:57-11:09 a.m.
CTOral Abstract Session: Hematologic Malignancies
– Leukemia, Myelodysplastic Syndromes, and
AllotransplantAbstract:
7004Location: E450abPresenter:
Eytan Stein, M.D., Memorial Sloan-Kettering Cancer Center and Weill
Cornell Medical CollegeThis abstract has been selected as part of
the “Best of ASCO” program to be presented in cities across the
country. “Best of ASCO” features the top abstracts, highlighting
the most cutting-edge science and education from the annual
meeting.
Poster discussions and poster presentations by Agios
and/or Celgene:
Title: Phase 1 study of AG-120, an IDH1 mutant
enzyme inhibitor: results from the cholangiocarcinoma dose
escalation and expansion cohortsPoster Session Date &
Time: Saturday, June 3, 2017 from 8:00-11:30 a.m.
CTPoster Discussion Date & Time: Saturday,
June 3, 2017 from 5:21-5:33 p.m. CTPoster Session:
Gastrointestinal (Noncolorectal) Cancer Abstract:
4015Poster Board: 7Poster
Location: Hall APoster Discussion
Location: Hall D2Presenter: Maeve Aine
Lowery, M.D., Memorial Sloan-Kettering Cancer Center and Weill
Cornell Medical College
Title: Differentiation syndrome associated with
enasidenib, a selective inhibitor of mutant isocitrate
dehydrogenase 2 (mIDH2)Poster Session Date &
Time: Monday, June 5, 2017 from 8:00-11:30 a.m.
CTPoster Discussion Date & Time: Monday, June
5, 2017 from 12:06-12:18 p.m. CTPoster Session:
Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and
Allotransplant Abstract: 7015Poster
Board: 215 Poster Location: Hall
APoster Discussion Location:
E354bPresenter: Amir Tahmasb Fathi, M.D.,
Massachusetts General Hospital and Harvard Medical School
Title: Pharmacokinetic/pharmacodynamic (PK/PD)
profile of AG-120 in patients with IDH1-mutant cholangiocarcinoma
from a phase 1 study of advanced solid tumorsDate &
Time: Saturday, June 3, 2017 from 8:00-11:30 a.m.
CTPoster Session: Gastrointestinal (Noncolorectal)
CancerAbstract: 4082Poster Board:
74Location: Hall AAuthor: Bin
Fan, Ph.D., Agios Pharmaceuticals
Title: ClarIDHy: A phase 3, multicenter,
randomized, double-blind study of AG-120 vs placebo in patients
with an advanced cholangiocarcinoma with an IDH1
mutationDate & Time: Saturday, June 3, 2017
from 8:00-11:30 a.m. CTPoster Session:
Gastrointestinal (Noncolorectal) CancerAbstract:
TPS4142Poster Board:
128bLocation: Hall AAuthor: Maeve
Aine Lowery, M.D., Memorial Sloan-Kettering Cancer Center and Weill
Cornell Medical College
About AgiosAgios is focused on discovering and
developing novel investigational medicines to treat cancer and rare
genetic diseases 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.
About Agios/Celgene Collaboration IDHIFA®
(enasidenib) and AG-881 are part of Agios' global strategic
collaboration with Celgene Corporation focused on cancer
metabolism. Under the terms of the 2010 collaboration agreement,
Celgene has worldwide development and commercialization rights for
IDHIFA® (enasidenib). Agios continues to conduct clinical
development activities within the IDHIFA® (enasidenib) development
program and is eligible to receive reimbursement for those
development activities and up to $95 million in remaining payments
assuming achievement of certain milestones and royalties on net
sales. Celgene and Agios intend to co-commercialize IDHIFA®
(enasidenib) in the U.S. Celgene will reimburse Agios for costs
incurred for its co-commercialization efforts.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding Agios’ plans, strategies and expectations for its and its
collaborator’s preclinical, clinical and commercial advancement of
its drug development programs including IDHIFA® (enasidenib) and
ivosidenib (AG-120); the potential benefits of Agios' product
candidates; its plans regarding future data presentations; and the
potential benefit of its strategic plans and focus. The words
“intend,” “will,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Such statements are
subject to numerous important factors, risks and uncertainties that
may cause actual events or results to differ materially from Agios'
current expectations and beliefs. For example, there can be no
guarantee that any product candidate Agios or its collaborator,
Celgene, is developing will successfully commence or complete
necessary preclinical and clinical development phases, or that
development of any of Agios' product candidates will successfully
continue. There can be no guarantee that any positive developments
in Agios' business will result in stock price appreciation.
Management's expectations and, therefore, any forward-looking
statements in this press release could also be affected by risks
and uncertainties relating to a number of other important factors,
including: Agios' results of clinical trials and preclinical
studies, including subsequent analysis of existing data and new
data received from ongoing and future studies; the content and
timing of decisions made by the U.S. FDA and other regulatory
authorities, investigational review boards at clinical trial sites
and publication review bodies; Agios' ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its planned clinical trials; unplanned cash requirements and
expenditures; competitive factors; Agios' ability to obtain,
maintain and enforce patent and other intellectual property
protection for any product candidates it is developing; Agios'
ability to maintain key collaborations, such as its agreements with
Celgene; and general economic and market conditions. These and
other risks are described in greater detail under the caption "Risk
Factors" included in Agios’ public filings with the Securities and
Exchange Commission. Any forward-looking statements contained in
this press release speak only as of the date hereof, and Agios
expressly disclaims any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
Contacts
Investors:
Kendra Adams, 617-844-6407
Senior Director, Investor & Public Relations
Kendra.Adams@agios.com
Renee Leck, 617-649-8299
Senior Manager, Investor & Public Relations
Renee.Leck@agios.com
Media:
Holly Manning, 617-844-6630
Associate Director, Corporate Communications
Holly.Manning@agios.com
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