Agios to Present Broad Set of Clinical and Translational Data for Oncology and Rare Genetic Disease Programs at the Virtual 2020 ASH Annual Meeting

CAMBRIDGE, Mass., Nov. 04, 2020 (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 a broad set of clinical and translational data from its oncology and rare genetic diseases programs will be presented at the American Society of Hematology (ASH) Annual Meeting being held virtually December 5–8, 2020.

In total, eight abstracts led by Agios will be presented, as well as three abstracts led by external collaborators. The accepted abstracts are listed below and are available online on the ASH conference website: .

Presentations by Agios

Oral Presentation

Abstract #625: Ivosidenib Improves Overall Survival Relative to Standard Therapies in Relapsed or Refractory Mutant IDH1 AML: Results from Matched Comparisons to Historical Controls

Date & Time: Monday, December 7, 2020 at 10:15 a.m. PST

Oral Session: 903. Health Services Research – Malignant Conditions (Myeloid Disease): Treatment and Publication Patterns in Myeloid Malignancies

Poster Presentations – Rare Genetic Diseases

Abstract #1627: Mortality Among Veterans with a Diagnosis of Pyruvate Kinase (PK) Deficiency: A Real-World Study Using US Veterans Health Administration Data

Poster Session Date & Time: Saturday, December 5, 2020 from 7:00 a.m. - 3:30 p.m. PST

Poster Session: 904. Outcomes Research – Non-Malignant Conditions: Poster I

Abstract #1679: Early-Onset Osteopenia and Osteoporosis in Patients with Pyruvate Kinase Deficiency

Poster Session Date & Time: Sunday, December 6, 2020 from 7:00 a.m. - 3:30 p.m. PST

Poster Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II

Abstract #2538: Baseline Characteristics of Patients in Peak: A Global, Longitudinal Registry of Patients with Pyruvate Kinase Deficiency

Poster Session Date & Time: Monday, December 7, 2020 from 7:00 a.m. - 3:30 p.m. PST

Poster Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III

Abstract #2600: Proof of Concept for the Oral Pyruvate Kinase Activator Mitapivat in Adults with Non-Transfusion-Dependent Thalassemia: Interim Results from and Ongoing, Phase 2, Open-Label, Multicenter Study

Poster Session Date & Time: Monday, December 7, 2020 from 7:00 a.m. - 3:30 p.m. PST

Poster Session: 112. Thalassemia and Globin Gene Regulation: Poster III

Poster Presentations – Oncology

Abstract #1943: Molecular Characterization of Clinical Response and Relapse in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib and Azacitidine

Poster Session Date & Time: Sunday, December 6, 2020 from 7:00 a.m. - 3:30 p.m. PST

Poster Session: 615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Poster II

Abstract #2814: AGILE: Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Ivosidenib in Combination with Azacitidine in Adults with Newly Diagnosed Acute Myeloid Leukemia and an IDH Mutation

Poster Session Date & Time: Monday, December 7, 2020 from 7:00 a.m. - 3:30 p.m. PST

Poster Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster III

Abstract #2900: Longitudinal Molecular Profiling in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib

Poster Session Date & Time: Monday, December 7, 2020 from 7:00 a.m. - 3:30 p.m. PST

Poster Session: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis Prognosis: Poster III

Presentations by External Collaborators

Oral Presentations

Abstract #84: The Pyruvate Kinase Activator AG-348 ameliorates anemia and prevents iron overload in a mouse model of hereditary spherocytosis

Date & Time: Saturday, December 5, 2020 at 10:15 a.m. PST

Oral Session: 101. Red Cells and Erythropoiesis, Structure, and Functions, Metabolism, and Survival, Excluding Iron: Mechanisms, Diagnosis and Treatment of Inherited

Presenter: Alessandro Mattè, BSc, PhD University of Verona and AOUI Verona

Abstract #681: Phase 1 Multiple Ascending Dose Study of Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Mitapivat (AG-348) in Subjects with Sickle Cell Disease

Date & Time: Monday, December 7, 2020 at 2:30 p.m. PST

Oral Session: 114. Hemoglobinopathies Excluding Thalassemia – Clinical: Novel Treatments for Sickle Cell Disease

Presenter: Julia Z. Xu, Sickle Cell Branch, National Heart, Lung, and Blood Institute

Poster Presentation

Abstract #2402: A Phase I Study of the IDH2 inhibitor enasidenib as maintenance therapy for IDH2-mutant myeloid neoplasms following hematopoietic

Date & Time: Sunday, December 6, 2020 from 7:00 a.m. - 3:30 p.m. PST

Poster Session: 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Post II

Event and Webcast Information

Agios will host a virtual investor event on December 8, 2020 at 8:00 a.m. ET to review the data from the company's rare genetic diseases program. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors section of the company's website at . The archived webcast will be available on the company's website beginning approximately two hours after the event.

About Agios

Agios is focused on discovering and developing novel investigational medicines to treat malignant hematology, solid tumors and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across these three therapeutic areas, Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development. For more information, please visit the company's website at

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 ivosidenib, enasidenib and mitapivat; Agios’ 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 collaborators 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 collaborators 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, without limitation: risks and uncertainties related to the impact of the COVID-19 pandemic to Agios’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products; 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, the EMA or 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; 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:

Holly Manning, 617-844-6630

Director, Investor Relations

Media:

Jessica Rennekamp, 857-209-3286

Associate Director, Corporate Communications