Agios Pharma Reports Initiation of Phase 1/2 Clinical Trial of AG-221 in Patients with Advanced Solid Tumors with IDH2 Mutation

Agios Pharmaceuticals,Inc. (Nasdaq: AGIO), a leader in the fields of cancer metabolism and raregenetic disorders of metabolism, today announced the initiation of a Phase 1/2multicenter study of AG-221 in patients with advanced solid tumors, includinggliomas, as well as angioimmunoblastic T-cell lymphoma (AITL) that carry anisocitrate dehydrogenase-2 (IDH2) mutation. The study will enroll patients whohave recurred or progressed following standard therapy or have not respondedto prior standard therapy. This is the second trial to be initiated inpatients with cancer as part of AG-221's clinical development program, whichincludes the ongoing Phase 1 trial with four expansion cohorts in patientswith hematologic malignancies.Preclinical evidence shows that mutant IDH2 enzyme, the target of AG-221,produces 2-hydroxyglutarate (2HG), which blocks the normal maturation ofprogenitor cells. In solid tumor cells expressing the IDH2 mutation, AG-221inhibited the production of 2HG, which has the potential to affectdifferentiation and cell proliferation in patients with solid tumors. Inaddition, AG-221 has demonstrated an acceptable safety profile and evidence ofantitumor activity in the ongoing Phase I trial of AG-221 in patients withadvanced hematologic malignancies that carry an IDH2 mutation."Evaluating AG-221 in patients with advanced solid tumors is an important nextstep in our efforts to understand the potential of this investigationalmedicine to treat a broad range of cancers with the IDH2 mutation," said ChrisBowden M.D., chief medical officer at Agios. "The safety, pharmacokinetics,clinical activity, and effect on the biomarker 2HG we have observed from thedifferent dose levels studied in the Phase 1 trial for advanced hematologicmalignancies give us insights into the potential to fight cancer in patientswith advanced solid tumors. AG-221 will only be evaluated in prospectivelydefined patients whose cancers carry an IDH2 mutation, and who we believe havethe greatest potential to benefit from treatment."