- New Safety and Efficacy Data from Ongoing Studies of AG-221 and AG-120 to be Highlighted in Oral and Poster Presentations -
- Posters to Feature Pharmacokinetics and Pharmacodynamics Data for AG-348 and Findings from Natural History Study of Pyruvate Kinase Deficiency -
- Company to Host Investor Event and Webcast on December 7, 2015 -
CAMBRIDGE, Mass., Nov. 5, 2015 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO ) today announced that new data from the ongoing dose-escalation and expansion studies of AG-221 and AG-120 in advanced hematologic malignancies will be presented at the 2015 American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, December 5-8, 2015.
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, as well as two abstracts detailing new findings from the Natural History Study of pyruvate kinase (PK) deficiency being conducted with Boston Children's Hospital. Agios' IDH inhibitors AG-221 and AG-120 are being developed in collaboration with Celgene.
The accepted abstracts are listed below and are now available online on the ASH conference website: https://ash.confex.com/ash/2015/webprogram/start.html .
Oral Presentation
Date & Time : Sunday, December 6, 2015 at 5:30 p.m. ET Session Title : 613. Acute Myeloid Leukemia: Clinical Studies: Advances in Targeted Therapy Abstract Number : 323 Presentation Title : Safety and Efficacy of AG-221, a Potent Inhibitor of Mutant IDH2 That Promotes Differentiation of Myeloid Cells in Patients with Advanced Hematologic Malignancies: Results of a Phase 1/2 Trial Location : Orange County Convention Center, W110
Poster Presentations
Date & Time : Saturday, December 5, 2015 from 5:30 p.m. to 7:30 p.m. ET Session Title : 613. Acute Myeloid Leukemia: Clinical Studies: Poster I Abstract Number : 1306 Presentation Title : Molecular Profiling and Relationship with Clinical Response in Patients with IDH1 Mutation-Positive Hematologic Malignancies Receiving AG-120, a First-in-Class Potent Inhibitor of Mutant IDH1, in Addition to Data from the Completed Dose Escalation Portion of the Phase 1 Study Location : Orange County Convention Center, Hall A
Date & Time : Saturday, December 5, 2015 from 5:30 p.m. to 7:30 p.m. ET Session Title : 613. Acute Myeloid Leukemia: Clinical Studies: Poster I Abstract Number : 1310 Presentation Title : Longitudinal Pharmacokinetic/Pharmacodynamic Profile of AG-120, a Potent Inhibitor of the IDH1 Mutant Protein, in a Phase 1 Study of IDH1-Mutant Advanced Hematologic Malignancies Location : Orange County Convention Center, Hall A
Date & Time : Sunday, December 6, 2015 from 6:00 p.m. to 8:00 p.m. ET Session Title : 613. Acute Myeloid Leukemia: Clinical Studies: Poster II Abstract Number : 2509 Presentation Title : Evaluation of the Pharmacokinetics of AG-221, a Potent Mutant IDH2 Inhibitor, in Patients with IDH2-Mutation Positive Advanced Hematologic Malignancies in a Phase 1/2 Trial Location : Orange County Convention Center, Hall A
Date & Time : Sunday, December 6, 2015 from 6:00 p.m. to 8:00 p.m. ET Session Title : 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II Abstract number: 2136 Presentation Title : The Phenotypic Spectrum of Pyruvate Kinase Deficiency (PKD) from the PKD Natural History Study (NHS): Description of Four Severity Groups By Anemia Status Location : Orange County Convention Center, Hall A
Date & Time : Monday, December 7, 2015 from 6:00 p.m. to 8:00 p.m. ET Session Title : 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III Abstract Number : 3337 Presentation Title : Molecular Characterization of 140 Patients in the Pyruvate Kinase Deficiency (PKD) Natural History Study (NHS): Report of 20 New Variants Location : Orange County Convention Center, Hall A
Date & Time : Monday, December 7, 2015 from 6:00 p.m. to 8:00 p.m. ET Session Title : 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III Abstract Number : 3336 Presentation Title : Population Pharmacokinetics and Pharmacodynamics of AG-348 in Healthy Human Volunteers Guide Dose Selection for the Treatment of Pyruvate Kinase Deficiency Location : Orange County Convention Center, Hall A
Investor Event and Webcast Information
Agios will host an investor event on Monday, December 7, 2015 beginning at 12:00 p.m. ET in Orlando to review data presented at ASH, including new data from the ongoing studies of AG-221 and AG-120. 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 benefits of Agios' product candidates targeting IDH1/IDH2 or pyruvate kinase-R mutations, including AG-221, AG-120 and AG-348; its plans for the clinical development of AG-221, AG-120 and AG-348; its plans regarding future data presentations; and the benefit of its strategic plans and focus. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "potential," "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 agreement 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, 2015, 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.
Renee Leck, Senior Manager, Investor and Public Relations 617-649-8299
