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Kura Oncology Receives FDA Clearance for IND Application of Menin Inhibitor Ziftomenib in Advanced Gastrointestinal Stromal Tumors (GIST)

NextEdge Admin

08 Aug 2024

1 min 57 sec

Kura Oncology, a clinical-stage biopharmaceutical company dedicated to advancing precision medicines for cancer treatment, announced that the FDA has cleared its Investigational New Drug (IND) application for ziftomenib, a potent and selective menin inhibitor, for advanced gastrointestinal stromal tumors (GIST). The company will begin a Phase 1 study of ziftomenib combined with imatinib, a targeted therapy for GIST, in early 2025.

“This milestone marks the first IND clearance of a menin inhibitor for GIST, offering new hope for patients with limited treatment options,” said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. “While imatinib is the frontline treatment for GIST, resistance often develops. Preclinical data suggest ziftomenib can resensitize patients to imatinib, leading to deep, durable responses. We are excited to present our preclinical findings at an upcoming scientific meeting and to begin clinical trials early next year.”

GIST, the most common form of sarcoma, is characterized by KIT-dependent tumors. Though KIT inhibitors like imatinib improve patient outcomes, resistance limits their efficacy. The menin-MLL complex regulates KIT expression, and menin inhibitors show additive effects with imatinib. Preclinical models indicate that combining ziftomenib with imatinib may resensitize resistant GIST patients, prompting the planned proof-of-concept study.