MD Anderson and Rigel Pharmaceuticals announce strategic alliance to advance olutasidenib in AML and other cancers

The University of Texas MD Anderson Cancer Center and Rigel Pharmaceuticals, Inc. today announced a multi-year strategic development collaboration to expand the evaluation of olutasidenib in acute myeloid leukemia (AML) and other hematologic cancers.

The alliance brings together MD Anderson’s clinical research expertise with Rigel’s differentiated targeted molecule. Under the strategic collaboration, Rigel and MD Anderson will evaluate the potential of olutasidenib to treat newly diagnosed and relapsed or refractory (R/R) patients with AML, higher-risk myelodysplastic syndromes (MDS) and advanced myeloproliferative neoplasms (MPN), in combination with other agents. The collaboration also will support the evaluation of olutasidenib as monotherapy in lower-risk MDS and as maintenance therapy in post-hematopoietic stem cell transplant patients.

“We are excited to enter into this strategic alliance with the exceptional team at MD Anderson to evaluate olutasidenib as a potential therapy for a broad range of IDH1-mutant cancers,” said Raul Rodriguez, president and chief executive officer at Rigel. “We believe olutasidenib has the potential to become a standard of care for patients in urgent need of new hematology-oncology therapies. We look forward to a close collaboration with MD Anderson to advance this as a new therapeutic option for more patients.”

Olutasidenib is a potent, selective, oral, small-molecule inhibitor of mutated IDH1 (mIDH1) designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells. Olutasidenib is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with R/R AML with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

“Based on its differentiated profile and compelling clinical data to date, olutasidenib has the potential, beyond its currently approved indication, to benefit patients with various cancers where mutant IDH1 is thought to play a role,” said Courtney DiNardo, M.D., professor of Leukemia. “We look forward to collaborating with Rigel to conduct in-depth studies that will determine the broader potential of olutasidenib in these patient populations.”

Rigel and MD Anderson will jointly lead all clinical development efforts, which will be overseen by a joint steering committee. Rigel will provide $15 million in time-based milestone payments and study material over the five-year collaboration. Rigel will retain all rights to its programs under the collaboration.