Agios to Present Updated Clinical Data from PKR Activator AG-348 at EHA
May 18 2017 - 7:08AM
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields
of cancer metabolism and rare genetic diseases, today announced
that updated clinical data from the fully enrolled, ongoing Phase 2
study (DRIVE PK) of AG-348 in adults with pyruvate kinase (PK)
deficiency, a rare, potentially debilitating, congenital anemia,
will be presented at the 22nd Congress of the European Hematology
Association (EHA) taking place June 22-25, 2017 in Madrid, Spain.
AG-348 is a wholly owned, novel, first-in-class, oral activator of
both wild-type (normal) and mutated pyruvate kinase-R (PKR)
enzymes.
The accepted abstracts are listed below and
available online on the EHA conference website:
http://learningcenter.ehaweb.org/eha/#!*listing=3*browseby=2*sortby=1*media=3*ce_id=1181*label=15531
Oral presentation by Agios:
Title: Effects of AG-348, a pyruvate kinase
activator, in patients with Pyruvate Kinase Deficiency: updated
results from the DRIVE-PK studyDate & Time:
Saturday, June 24, 2017 from 11:30-11:45 a.m. CETSession
Title: Sickle cell disease, enzymesAbstract
Code: S451Location: Room
N109Presenter: Rachael Grace, M.D., Dana-Farber
Boston Children's Cancer and Blood Disorder CenterUpdated data from
the DRIVE PK study will be presented at the time of the
meeting.
Poster presentation by Agios collaborator:
Title: Ex-vivo treatment of red blood cells
from 15 Pyruvate Kinase (PK)-deficient patients with AG-348, an
allosteric activator of PK-R, increases enzymatic activity, protein
stability and ATP levelsDate & Time: Saturday,
June 24, 2017 from 5:30-7:00 p.m. CETSession
Title: Enzymes and sickle cell diseaseAbstract
Code: P614Location: Poster area (Hall
7)Author: Richard van Wijk, Ph.D., University
Medical Center Utrecht
Encore presentations 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 studyDate &
Time: Saturday, June 24, 2017 from 4:00-4:15 p.m.
CETOral Abstract Session: Targeted treatment of
AMLAbstract Code: S471Location:
Hall DPresenter: Eytan Stein, 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: Friday, June 23, 2017 from 5:15-6:45 p.m.
CETSession Title: Acute myeloid leukemia -
Clinical 3Abstract Code:
P215Location: Poster area (Hall
7)Author: Amir Tahmasb Fathi, M.D., Massachusetts
General Hospital and Harvard Medical School
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
collaborators’ preclinical, clinical and commercial advancement of
its drug development programs including AG-348 and IDHIFA®
(enasidenib); 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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