Rigel Pharmaceuticals and MD Anderson Establish Strategic Collaboration to Progress REZLIDHIA® (Olutasidenib) in AML and Other Cancer Forms

Rigel Pharmaceuticals, Inc. and The University of Texas MD Anderson Cancer Center have recently revealed a strategic development collaboration spanning multiple years to extend the assessment of REZLIDHIA® (olutasidenib) in acute myeloid leukemia (AML) and other hematologic cancers. 

This collaboration amalgamates MD Anderson's clinical research prowess with Rigel's unique targeted molecule. Within this partnership, Rigel and MD Anderson will investigate olutasidenib's potential in treating newly diagnosed and relapsed or refractory (R/R) patients with AML, higher-risk myelodysplastic syndromes (MDS), and advanced myeloproliferative neoplasms (MPN), in conjunction with other agents. Additionally, the collaboration will facilitate the evaluation of olutasidenib as monotherapy in lower-risk MDS and as maintenance therapy in post-hematopoietic stem cell transplant patients.

Expressing enthusiasm for the strategic alliance, Raul Rodriguez, Rigel's president, and CEO underscored the potential of REZLIDHIA to become a standard of care for patients with various IDH1-mutant cancers. The collaboration aims to advance this therapeutic option for a broader range of patients in need of new hematology-oncology therapies.

REZLIDHIA, an oral, small-molecule inhibitor of mutated IDH1 (mIDH1), holds FDA approval for treating adult patients with R/R AML with a susceptible IDH1 mutation. The drug is designed to inhibit mIDH1, reduce 2-hydroxyglutarate levels, and restore normal cellular differentiation of myeloid cells.

Courtney DiNardo, M.D., professor of Leukemia, emphasized the potential of REZLIDHIA beyond its current approval and its ability to benefit patients with various cancers where mutant IDH1 is implicated. Rigel and MD Anderson will jointly lead all clinical development efforts through a joint steering committee. Rigel will contribute $15 million in time-based milestone payments and study material over the five-year collaboration, while retaining all rights to its programs.

AML is a swiftly progressing cancer affecting myeloid cells in the blood and bone marrow. The collaboration seeks to address the unmet need for well-tolerated treatments in relapsed or refractory AML, where quality of life tends to decline with each successive line of treatment. REZLIDHIA, with its differentiated profile and clinical data, holds the promise of benefiting patients beyond its current indication.

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