Press Release Details

– 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 –

– First Data from the Ivosidenib (AG-120) Phase 1 Cholangiocarcinoma Expansion Cohort to be Presented in Poster Discussion –

CAMBRIDGE, Mass., May 17, 2017 (GLOBE NEWSWIRE) -- 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. CT
Oral Abstract Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7004
Location: E450ab
Presenter: Eytan Stein, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College
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 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 cohorts
Poster Session Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Discussion Date & Time: Saturday, June 3, 2017 from 5:21-5:33 p.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: 4015
Poster Board: 7
Poster Location: Hall A
Poster Discussion Location: Hall D2
Presenter: 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. CT
Poster Discussion Date & Time: Monday, June 5, 2017 from 12:06-12:18 p.m. CT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7015
Poster Board: 215  
Poster Location: Hall A
Poster Discussion Location: E354b
Presenter: 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 tumors
Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: 4082
Poster Board: 74
Location: Hall A
Author: 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 mutation
Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: TPS4142
Poster Board: 128b
Location: Hall A
Author: Maeve Aine Lowery, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College

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 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 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 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