– Updated Data From Ivosidenib Phase 1 Expansion in IDH1m R/R AML and the First Data from the AG-881 Phase 1 Study in IDHm Glioma to be Highlighted in Oral Presentations –

New Data From Fully Enrolled Ivosidenib Arm of the Phase 1/2 Combination Trial of Enasidenib or Ivosidenib with VIDAZA® in Newly Diagnosed AML to be Featured in Poster Presentation

CAMBRIDGE, Mass., May 16, 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 new data from its isocitrate dehydrogenase (IDH) programs will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 1-5, 2018 in Chicago.

In total, five abstracts led by Agios describing new data from the company's IDH programs have been accepted for presentation at ASCO, as well as one abstract led by Celgene Corporation. IDHIFA® (enasidenib) is being commercialized in collaboration with Celgene.

The accepted abstracts are listed below and are available online on the ASCO conference website: http://abstracts.asco.org/

Oral presentations by Agios:

Title: Phase 1 Study of AG-881, an Inhibitor of Mutant IDH1/IDH2, in Patients with Advanced IDH-mutant Solid Tumors, Including Glioma
Date & Time: Friday, June 1, 2018 from 3:09-3:21 p.m. CT
Oral Abstract Session: Central Nervous System Tumors
Abstract: 2002
Location: S102
Presenter: Ingo K. Mellinghoff, M.D., Memorial Sloan Kettering Cancer Center

Title: Ivosidenib (IVO; AG-120) in Mutant IDH1 Relapsed/Refractory AML: Results of a Phase 1 Study
Date & Time: Saturday, June 2, 2018 from 3:00-3:12 p.m. CT
Oral Abstract Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7000
Location: E450
Presenter: Daniel Aaron Pollyea, M.D., M.S., University of Colorado School of Medicine
This 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 presentations by Agios and/or Celgene:

Title: Mutant IDH (mIDH) Inhibitors, Ivosidenib or Enasidenib, with Azacitidine (AZA) in Patients with Acute Myeloid Leukemia (AML)
Poster Session Date & Time: Monday, June 4, 2018 from 8:00-11:30 a.m. CT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7042
Poster Board: 102
Poster Location: Hall A
Author: Courtney Denton DiNardo, M.D., University of Texas MD Anderson Cancer Center

Title: AGILE: A Phase 3, Multicenter, Randomized, Placebo-Controlled Study of Ivosidenib in Combination with Azacitidine in Adult Patients with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation
Poster Session Date & Time: Monday, June 4, 2018 from 8:00-11:30 a.m. CT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: TPS7074
Poster Board: 133b
Poster Location: Hall A
Author: Eytan Stein, M.D., Memorial Sloan Kettering Cancer Center

Title: Pharmacokinetics/pharmacodynamics (PK/PD) of Ivosidenib in Patients with IDH1-mutant Advanced Solid Tumors from a Phase 1 Study
Poster Session Date & Time: Monday, June 4, 2018 from 8:00-11:30 a.m. CT
Poster Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Abstract: 2577
Poster Board: 403   
Poster Location: Hall A
Author: Bin Fan, Ph.D., Agios Pharmaceuticals

Title: Clinical pharmacokinetics/pharmacodynamics (PK/PD) of Ivosidenib in Patients with IDH1-mutant Advanced Hematologic Malignancies from a Phase 1 Study
Poster Session Date & Time: Monday, June 4, 2018 from 8:00-11:30 a.m. CT
Poster Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Abstract: 2581
Poster Board: 407   
Poster Location: Hall A
Author: David Dai, 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 an approved oncology precision medicine 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.

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 certain 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 any net sales. Celgene and Agios are currently co-commercializing IDHIFA® (enasidenib) in the U.S. Celgene will reimburse Agios for costs incurred for its co-commercialization efforts. For AG-881, the companies have a joint worldwide development and 50/50 profit share collaboration, and Agios is eligible to receive regulatory milestone payments of up to $70 million.

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' product candidates, including IDHIFA®, ivosidenib, and AG-881; 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. 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:
Renee Leck, 617-649-8299
Senior Manager, Investor Relations
Renee.Leck@agios.com 

Media:
Holly Manning, 617-844-6630
Associate Director, Corporate Communications
Holly.Manning@agios.com