Kura Oncology announces FDA clearance of IND application for ziftomenib

Kura Oncology announced clearance by the U.S. Food and Drug Administration, FDA, of the Investigational New Drug, IND, application for ziftomenib, the Company’s potent and selective menin inhibitor, for the treatment of advanced gastrointestinal stromal tumors. The Company plans to initiate a Phase 1 first-in-human study of ziftomenib in combination with imatinib, a targeted therapy approved for the treatment of GIST, in early 2025. “This important milestone represents the first IND clearance of a menin inhibitor to treat GIST, a solid tumor indication with limited treatment options for patients with advanced disease,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Although imatinib is utilized in frontline GIST patients, many eventually develop resistance. Our preclinical data suggest ziftomenib has potential to resensitize patients to imatinib and induce deep, durable responses. We look forward to presenting the preclinical data for the combination at an upcoming scientific meeting and initiating a proof-of-concept clinical study early next year.”