– Updated Single Agent Ivosidenib Data in Previously Untreated Acute Myeloid Leukemia (AML) Patients from
Phase 1 Study Chosen for Oral Presentation –
– Updated Data from Phase 1 Frontline AML Combination Study of Ivosidenib or Enasidenib and Intensive
Chemotherapy Chosen for Oral Presentation –
CAMBRIDGE, Mass., Nov. 01, 2018 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the
field of cellular metabolism to treat cancer and rare genetic diseases, today announced that updated data from its isocitrate
dehydrogenase (IDH) programs and pyruvate kinase (PK) deficiency program will be presented at the American Society of Hematology
(ASH) Annual Meeting being held December 1 - 4, 2018 in San Diego.
In total, five abstracts led by Agios describing updated data from the company's IDH programs and PKD program
have been accepted for presentation at ASH.
The accepted abstracts are listed below and are available online on the ASH conference website: https://ash.confex.com/ash/2018/webprogram/start.html.
Oral presentations by Agios:
Title: Ivosidenib (AG-120) Induced Durable Remissions and Transfusion Independence in Patients
with IDH1-Mutant Untreated AML: Results from a Phase 1 Dose Escalation and Expansion Study
Date & Time: Monday December 3, 2018 at 7:30 a.m. PST
Oral Abstract Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Targeted Therapy
Abstract: 561
Location: Manchester Grand Hyatt San Diego, Seaport Ballroom F
Presenter: Gail J. Roboz, M.D., Weill Cornell Medical College
Title: Ivosidenib or Enasidenib Combined with Induction and Consolidation Chemotherapy in
Patients with Newly Diagnosed AML with an IDH1 or IDH2 Mutation is Safe, Effective, and Leads to MRD-Negative Complete Remissions
Date & Time: Monday December 3, 2018 at 7:15 a.m. PST
Oral Abstract Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Targeted Therapy
Abstract: 560
Location: Manchester Grand Hyatt San Diego, Seaport Ballroom F
Presenter: Eytan Stein, M.D., Memorial Sloan Kettering Cancer Center
Poster presentations by Agios:
Title: Ivosidenib (AG-120) Induced Durable Remissions and Transfusion Independence in Patients
with IDH1-Mutant Relapsed or Refractory Myelodysplastic Syndrome: Results from a Phase 1 Dose Escalation and Expansion Study
Poster Session Date & Time: Saturday December 1, 2018 from 6:15-8:15 p.m. PST
Poster Session: 637. Myelodysplastic Syndromes—Clinical Studies: Poster I
Abstract: 1812
Poster Location: San Diego Convention Center, Hall GH
Author: Courtney Denton DiNardo, M.D., University of Texas MD Anderson Cancer Center
Title: Population Pharmacokinetics of Ivosidenib (AG-120) in Patients with IDH1-Mutant Advanced
Hematologic Malignancies
Poster Session Date & Time: Saturday December 1, 2018 from 6:15-8:15 p.m. PST
Poster Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I
Abstract: 1394
Poster Location: San Diego Convention Center, Hall GH
Author: Kha Le, Ph.D., Agios Pharmaceuticals
Title: Genotype-Response Correlation in DRIVE PK, a Phase 2 Study of AG-348 in Patients with
Pyruvate Kinase Deficiency
Poster Session Date & Time: Monday December 3, 2018 from 6:00-8:00 p.m. PST
Poster Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding
Iron: Poster III
Abstract: 3621
Poster Location: San Diego Convention Center, Hall GH
Author: Charles Kung, Ph.D., Agios Pharmaceuticals
About Agios
Agios 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 two approved oncology precision medicines and multiple first-in-class investigational therapies 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.
Cautionary Note Regarding Forward-Looking Statements
This 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 the potential benefits of Agios' products and product candidates, including
IDHIFA® (enasidenib), TIBSOVO® (ivosidenib) and AG-348; its plans regarding future data presentations; and the potential benefit of
its strategic plans and focus. The words “anticipate,” “expect,” “intend,” “potential,” “milestone,” “goal,” “will,” “on track,”
“upcoming,” 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. Moreover, there can be no guarantee that the two approved oncology precision medicines being commercialized by Agios and
its collaborator Celgene will receive commercial acceptance. 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 CStone Pharmaceuticals; 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:
Renee Leck, 617-649-8299
Associate Director, Investor Relations
Renee.Leck@agios.com
Media:
Holly Manning, 617-844-6630
Associate Director, Corporate Communications
Holly.Manning@agios.com
