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Rigel Pharmaceuticals Inks Deal With MD Anderson to Study Rezlidhia in New Indications

NEW YORK – Rigel Pharmaceuticals on Friday said it signed a collaboration agreement with the University of Texas MD Anderson Cancer center to expand clinical studies of its mutant IDH1 inhibitor Rezlidhia (olutasidenib) beyond its currently approved indication.

Rezlidhia is approved by the US Food and Drug Administration as a treatment for adult patients with relapsed and refractory acute myeloid leukemia bearing certain IDH1 mutations as detected by an FDA-approved test. Under the terms of the five-year collaboration agreement, Rigel and MD Anderson will evaluate Rezlidhia as a treatment for newly diagnosed and relapsed or refractory AML, higher-risk myelodysplastic syndromes (MDS), and advanced myeloproliferative syndromes in combination with other agents. The collaboration will also include assessment of Rezlidhia as a monotherapy in lower-risk MDS and as a maintenance therapy for patients who have had a hematopoietic stem cell transplant.

San Diego-based Rigel and MD Anderson will conduct all clinical development efforts jointly, overseen by a steering committee, and Rigel will pay $15 million to MD Anderson in milestone payments and provide drug material for study. Rigel will retain rights to all of its programs under the collaboration.

"Based on its differentiated profile and compelling clinical data to date, Rezlidhia has the potential, beyond its currently approved indication, to benefit patients with various cancers where mutant IDH1 is thought to play a role," Courtney DiNardo, a professor of leukemia at MD Anderson, said in a statement.