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Agios Reports First Quarter 2016 Financial Results

Five Abstracts Accepted for Presentation at EHA in June, Including First Data from AG -348 Phase 2 DRIVE PK Study in PK Deficiency and AG-519 Phase 1 Healthy Volunteer Study Enrollment Complete in AG-221 Phase 2 Expansion Cohort in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

CAMBRIDGE, Mass., May 05, 2016 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. AGIO, -5.07% a leader in the fields of cancer metabolism and rare genetic metabolic disorders, today reported business highlights and financial results for the first quarter ended March 31, 2016.

"We have been focused on executing against the important milestones we laid out in January, and I'm proud of the progress across both our cancer and rare genetic disorders programs to date," said David Schenkein, M.D., chief executive officer at Agios. "Notably, enrollment is complete ahead of schedule for the Phase 2 expansion cohort for the Phase 1/2 study of AG-221 in advanced AML. This achievement is crucial to getting this potential new therapy to patients as quickly as possible. Additionally, we are pleased that the first data from our Phase 2 DRIVE PK study of AG-348 will be presented at EHA this June, along with the first data from the Phase 1 study of AG-519 in healthy volunteers."

FIRST QUARTER 2016 HIGHLIGHTS & RECENT PROGRESS

PKR Activators:

  • An abstract for the first data from DRIVE PK, a global Phase 2, open-label safety and efficacy trial of AG-348 in adult, transfusion-independent patients with pyruvate kinase (PK) deficiency has been accepted for presentation at the 21st Congress of the European Hematology Association (EHA) in June 2016. An abstract for preclinical data for AG-348 in beta-thalassemia has also been accepted for presentation at EHA.
  • Three abstracts on AG-519, including from the Phase 1 study in healthy volunteers and preclinical findings on the molecule, have been accepted for presentation at EHA.

Agios provided the following updates on its clinical development programs in collaboration with Celgene:

IDH Mutant Inhibitors in Hematologic Malignancies:

  • Completed enrollment of the Phase 2 expansion cohort for the Phase 1/2 study of AG-221 in patients with R/R AML in May 2016
  • Initiated a Phase 1/2 frontline combination study of AG-221 or AG-120 with VIDAZA [(R)] (azacitidine) in newly diagnosed AML patients not eligible for intensive chemotherapy in March 2016
  • Received EMA Orphan Drug Designation for AG-221 for the treatment of AML in April 2016

Cancer Metabolism Research:

  • In April, Agios published preclinical findings from its program focused on MTAP (methylthioadenosine phosphorylase) deleted cancers in the peer-reviewed journal Cell Reports

2016 EXPECTED MILESTONES IN CANCER METABOLISM PROGRAMS

IDH Mutant Inhibitors in Hematologic Malignancies:

  • Complete enrollment of the 125-patient expansion cohort for the Phase 1 study of AG-120 in patients with R/R AML in the second half of 2016
  • Initiate a global, registration-enabling Phase 3 study of AG-120 in frontline AML patients with an IDH1 mutation in the second half of 2016
  • Initiate an expansion arm in high-risk myelodysplastic syndrome patients for AG-221 in 2016
  • Continue to enroll patients in the following ongoing clinical trials:
    • Phase 3 IDHENTIFY study of AG-221 vs. standard of care chemotherapy in R/R AML
    • Phase 1b frontline combination study of AG-221 or AG-120 with standard-of-care intensive chemotherapy in AML
    • Phase 1/2 frontline combination study of AG-221 or AG-120 with VIDAZA [(R)] in AML
    • Phase 1 dose-escalation and expansion study of AG-881 in IDH mutant positive hematologic malignancies

IDH Mutant Inhibitors in Solid Tumors:

  • Present data from the expansion phase of the ongoing Phase 1 study of AG-120 in advanced IDH1 mutant positive low-grade glioma in the second half of 2016
  • Initiate a randomized Phase 2 study of AG-120 in IDH1 mutant positive cholangiocarcinoma in the second half of 2016
  • Continue to enroll patients in the following ongoing clinical trials:
    • Expansion phase of the ongoing Phase 1 study of...

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