- Updated Safety and Efficacy Data from AG-348, AG-519 and Completed Dose Escalation Portion of AG-120 Study to be Highlighted in Oral and Poster Presentations - - Company to Host Investor Event and Webcast on December 4, 2016 - CAMBRIDGE, Mass., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) today announced that new data from the company's lead programs will be presented at the 2016 American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, December 3-6, 2016. In total, five abstracts led by Agios describing new clinical data from the company's cancer metabolism and rare genetic metabolic disorders programs have been accepted for presentation at ASH. Two additional abstracts from Celgene and Boston Children's Hospital have also been accepted. The accepted abstracts are listed below and are now available online on the ASH conference website: https://ash.confex.com/ash/2016/webprogram/start.html Oral Presentations Effects of AG-348, a Pyruvate Kinase Activator, on Anemia and Hemolysis in Patients With Pyruvate Kinase Deficiency: Data From the DRIVE PK Study Date & Time: Sunday, December 4, 2016 at 5:45 p.m. PT Session Title: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Anemia and Disordered Erythropoiesis Abstract Number: 402 Location: San Diego Convention Center, Room 7AB Determination of IDH1 Mutational Burden and Clearance via Next-Generation Sequencing in Patients With IDH1 Mutation-Positive Hematologic Malignancies Receiving AG-120, a First-in-Class Inhibitor of Mutant IDH1 Date & Time: Monday, December 5, 2016 at 4:45 p.m. PT Session Title: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: FLT3 and IDH Targeted Therapies in AML Abstract Number: 1070 Location: Marriott Marquis San Diego Marina, San Diego Ballroom AB Enasidenib (AG-221), a Potent Oral Inhibitor of Mutant Isocitrate Dehydrogenase 2 (IDH2) Enzyme, Induces Hematologic Responses in Patients with Myelodysplastic Syndromes (MDS) Date & Time: Sunday, December 4, 2016 at 9:30 a.m. PT Session Title: 637. Myelodysplastic Syndromes—Clinical Studies: Higher Risk MDS Clinical Studies Abstract Number: 343 Location: Manchester Grand Hyatt San Diego, Grand Hall C Poster Presentations Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of AG-519, an Allosteric Activator of Pyruvate Kinase-R, in Healthy Subjects Date & Time: Saturday, December 3, 2016 from 5:30 p.m. to 7:30 p.m. PT Session Title: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster I Abstract Number: 1264 Location: San Diego Convention Center, Hall GH Population Pharmacokinetics and Pharmacodynamics of AG-519, a Pyruvate Kinase Activator for the Treatment of Pyruvate Kinase Deficiency, in Human Healthy Volunteers Date & Time: Saturday, December 3, 2016 from 5:30 p.m. to 7:30 p.m. PT Session Title: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster I Abstract Number: 1263 Location: San Diego Convention Center, Hall GH Characterization of Metabolic Response to AG-348, an Allosteric Activator of Red Cell Pyruvate Kinase, in Healthy Volunteers and Pyruvate Kinase Deficiency Patients Date & Time: Sunday, December 4, 2016 from 6:00 p.m. to 8:00 p.m. PT Session Title: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II Abstract Number: 2452 Location: San Diego Convention Center, Hall GH Iron Overload is Highly Prevalent in All Disease Severity States in Pyruvate Kinase Deficiency (PKD) Date & Time: Sunday, December 4, 2016 from 6:00 p.m. to 8:00 p.m. PT Session Title: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II Abstract number: 2430 Location: San Diego Convention Center, Hall GH Investor Event and Webcast Information Agios will host an investor event on Sunday, December 4, 2016 beginning at 8:00 p.m. PT in San Diego to review data presented at ASH, including new data from the ongoing studies of AG-348 and AG-519. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors and Media section of the company's website at www.agios.com. About Agios Agios is focused on discovering and developing novel investigational medicines to treat cancer and rare genetic metabolic disorders 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 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 of IDH1/IDH2 and pyruvate kinase-R mutations, or other mutations, as therapeutic targets; the potential benefits of Agios' product candidates targeting IDH1/IDH2 or pyruvate kinase-R mutations or other genetic mutations, including Enasidenib, AG-120, AG-881, AG-348 and AG-519; its plans and timelines for the clinical development of AG-221, AG-120, AG-881, AG-348 and AG-519; its plans regarding future data presentations; and the potential benefit of its strategic plans and focus. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "potential," "possible," "hope," "could," "would" 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 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' Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, and other filings that Agios may make with the Securities and Exchange Commission in the future. 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.
Agios Pharmaceuticals:Kendra Adams, 617-844-6407Senior Director, Investor & Public RelationsKendra.Adams@agios.comRenee Leck, 617-649-8299Senior Manager, Investor & Public RelationsRenee.Leck@agios.com