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

– Preclinical data suggest combination of ziftomenib and imatinib has potential to resensitize patients to imatinib and induce durable responses –

– Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 –

Excerpt from the Press Release:

SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today 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 (GIST). 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.”

GIST is the most common form of sarcoma, characterized as KIT-dependent solid tumors. KIT inhibitors are associated with favorable outcomes for patients with GIST, and imatinib is the standard of care in this patient population. For patients who progress on imatinib, subsequent treatment options include other KIT inhibitors; however, these options are limited by moderate efficacy and challenging tolerability. The menin-MLL complex regulates KIT expression in GIST cells, and menin inhibitors display additive therapeutic activity with imatinib in imatinib-sensitive GIST models¹. Preclinical data in imatinib-resistant PDX models suggest that ziftomenib in combination with imatinib has the potential to resensitize patients to imatinib and induce durable responses.

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