The University of Texas MD Anderson Cancer Center and Rigel Pharmaceuticals, Inc. announced today a multi-year strategic development collaboration to extend the evaluation of olutazidenib in acute myeloid leukemia (AML) and other hematologic cancers.
The alliance combines MD Anderson’s clinical research expertise with Rigel’s differentiated targeted molecule. As part of 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), combined. with other agents. The collaboration will also support the evaluation of olutasidenib as monotherapy in lower-risk MDS and as maintenance therapy in patients after hematopoietic stem cell transplantation.
We are excited to enter into this strategic alliance with the outstanding team at MD Anderson to evaluate olutazidenib as a potential treatment for a broad spectrum of IDH1-mutant cancers. We believe that olutasidenib has the potential to become a standard of care for patients in urgent need of new hematologic-oncology therapies. We look forward to working closely with MD Anderson to advance this as a new treatment option for more patients.”
Raul Rodriguez, President and CEO of Rigel
Olutasidenib is a potent, selective, oral, small molecule inhibitor of mutant IDH1 (MIDH1) is designed to bind 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, olutazidenib has the potential, beyond its currently approved indication, to benefit patients with a variety of cancers where mutated IDH1 is thought to play a role,” he said. Courtney DiNardo, MD, professor of Leukemia; . “We look forward to working 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 materials over the five-year partnership. Rigel will retain all rights to its programs under the partnership.