Kura Oncology (KURA) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Strategic program focus and pipeline updates

• Menin inhibitor program, led by Ziftomenib, is advancing in both monotherapy and combination settings for genetically defined AML, aiming to treat up to 50% of patients across the care continuum.

• Expansion into solid tumors is underway, starting with GIST in combination with Imatinib, with plans to restore tumor sensitivity and potentially match the scale of frontline AML opportunities.

• Preclinical data in diabetes shows Ziftomenib lowers glucose, restores insulin sensitivity, and expands beta islet cells; a next-generation Menin inhibitor is planned for clinical development in this indication.

• Farnesyltransferase inhibitor (FTI) program is progressing, with monotherapy and combination studies in HRAS mutant head and neck, renal cell carcinoma, and KRAS-driven lung cancer.

• Multiple clinical data readouts and catalysts are expected over the next 12–24 months across programs.

Differentiation and clinical strategy for Ziftomenib

• Ziftomenib is distinguished by exceptional safety, tolerability, and lack of drug-drug interactions, supporting its use in combination regimens.

• No chronic toxicities observed except for manageable differentiation syndrome, which is mitigated in combination settings.

• Superior tissue penetration and exposure make Ziftomenib more effective in solid tumors compared to competitors.

• Monotherapy pivotal data is expected early next year, with a CR/CRh rate of 20–30% and median response duration of 4–6 months considered sufficient for approval.

• The focus is on moving Ziftomenib into frontline combination studies to maximize clinical and commercial impact.

Combination studies and trial design

• Combination strategies target three AML populations: fit (intensive chemo), unfit (Venetoclax/Azacitidine), and FLT3-mutant, with ongoing and planned studies in each.

• Ziftomenib is being combined with Gilteritinib and plans are in place to combine with Quizartinib, aiming to cover over 50% of AML patients.

• KOMET-007 study includes four parallel cohorts across three doses, with over 100 patients enrolled; 600 mg identified as the optimal dose for expansion and future registrational studies.

• FDA has allowed transition from dose escalation to expansion without additional review, supporting the 600 mg dose.

• Data update at ASH will focus on escalation cohorts, with expansion data expected to mature by mid-next year.