Kura Oncology, Inc. · NASDAQ:KURA

Kura Oncology — SIE (Italian Hematology Society) 2023 Congress

15 slides from Kura Oncology's conference presentation, 2023

  1. Slide 1: Activity, Tolerability and Resistance Profile of the Menin Inhibitor Ziftomenib in R/R NPM1-Mutated AML

    Activity, Tolerability and Resistance Profile of the Menin Inhibitor Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutated AML Cristina Papayannidis, MD, PhD

  2. Slide 2: Disclosures

    Disclosures Cristina Papayannidis, MD, PhD • No Disclosures

  3. Slide 3: NPM1-Mutant AML is a Large Genetic Subset with a High Unmet Need

    NPM1-Mutant AML is a Large Genetic Subset1 with a High Unmet Need NPM1-mutant AML ~30% ~6,000 new cases annually in the U.S.2 NPM1-m AML 5-year Overall Survival ~50%3 Adult patients with NPM1-mutant AML and select co-mutations and/or relapsed/refractory disease have a poor prognosis1 Median overall

  4. Slide 4: Ziftomenib Targets the Menin-KMT2A Pathway, a Foundational Target in AML

    Ziftomenib Targets the Menin-KMT2A Pathway, a Foundational Target in AML • NPM1-m and KMT2A-r drive overexpression of HOXA9/MEIS1 genes, critical for transformation to AML • KMT2A(MLL) sits upstream from major AML targets (i.e., FLT3, IDH1/2, DNMT3A) • KMT2A(MLL)-dependent genes contribute to therap

  5. Slide 5: KOMET-001 Phase 1/2 Study of Ziftomenib in R/R AML

    KOMET-001 Phase 1/2 Study of Ziftomenib in R/R AML Phase 1a Phase 1b Phase 1b Phase 2 Dose Escalation Validation Cohorts Expansion Registration-Enabling Completed Completed Completed (Ongoing) Ongoing 50 mg Cohort 1: 200 mg QD Expansion of 600 mg QD ~ ~ 100 mg 1000 mg QD QD 600 mg QD Cohort 2: 600 m

  6. Slide 6: Baseline Patient Characteristics

    Baseline Patient Characteristics Demographics 600 mg, n = 20 Disposition 600 mg, n = 20 Age, median (min, max), y 70.5 (22, 86) Patients in follow-up, n (%) 7 (35) Male, n (%) 6 (30) Reason for treatment discontinuation, n (%) ECOG PS 0, n (%) 3 (15) Adverse event (not study drug-related) 2 5 (25) P

  7. Slide 7: Phase 1b Safety and Tolerability of Ziftomenib in R/R NPM1-m AML

    Phase 1b Safety and Tolerability of Ziftomenib in R/R NPM1-m AML ≥ 20% Treatment-Emergent Adverse Events, n (%) NPM1-m, n = 20 ≥ 20% Treatment-Related Adverse Events, n (%) NPM1-m, n = 20 Patients with TEAEs (All Grades) 19 (95) Patients with TRAEs (All Grades) 12 (60) Diarrhea 9 (45) Nausea 4 (20)

  8. Slide 8: Ziftomenib Demonstrates Encouraging Clinical Activity

    Ziftomenib Demonstrates Encouraging Clinical Activity Mean Change in Platelets and ANC Best Overall Response n (%) for CRc up to C7D1 Complete remission rate (CR) 7 (35) 33% CR co-FLT3m CRc rate (CR+CRh+CRi) 8 (40) (N=6) 50% CR Overall response rate co-IDHm 9 (45) (CR+CRh+CRi+MLFS) (N=8) CR 7 (35) C

  9. Slide 9: Ziftomenib Monotherapy Drives Durable Responses

    Ziftomenib Monotherapy Drives Durable Responses • Median DoR 8.2 months (95% CI: 1.0 to Not Evaluable) with a median follow up time of 8.8 months • Patient 1 remained on ziftomenib in CR (MRD-) into Cycle 36 • Patients 9 and 21 proceeded to HSCT • Patient 9 remains in complete response on ziftomenib

  10. Slide 10: Ziftomenib Clears Measurable Residual Disease (MRD), Including Sub-Clones

    Ziftomenib Clears Measurable Residual Disease (MRD), Including Sub- Clones Local MRD Analysis1 • 67% of patients (4 of 6) achieving CRc were MRD-negative2 Ongoing Central MRD Analysis, by NGS (Representative Patients)3 NPM1 FLT3-TKD IDH1 Subject 2: Prior Tx with NPM1 FLT3-ITD IDH2 Subject 1: Prior T

  11. Slide 11: Ziftomenib Active Against Known Menin Gatekeeper Mutations

    Ziftomenib Active Against Known Menin Gatekeeper Mutations • No major conformational changes observed in MeninT349M vs. wild-type (WT) protein • M327 and Y324 side chains adopt new conformations in MeninT349M but do not affect ziftomenib binding • Binding affinity of ziftomenib is reduced for MeninM

  12. Slide 12: Ziftomenib Appears Less Susceptible to Observed Mutations Associated with Resistance to Menin Inhibition

    Ziftomenib Appears Less Susceptible to Observed Mutations Associated with Resistance to Menin Inhibition • Following reports of MEN1 resistance mutations with another menin inhibitor1, an analysis of KOMET-001 identified 1 of 29 subjects (3.4%) with the resistance mutation (MEN1-M327I) acquired whil

  13. Slide 13: Conclusions

    Conclusions • Ziftomenib demonstrates significant clinical activity with 45% ORR (35% CR rate) and lack of myelosuppression, with maintained count recovery in heavily pretreated R/R NPM1-m AML • Durable remissions with MRD clearance of foundational NPM1-m and other key co-mutations, including FLT3 I

  14. Slide 14: Acknowledgements

    Acknowledgements • The patients, their families, and caregivers • The study investigators and their study teams: • Centre Hospitalier Lyon-Sud • Hospital Universitario Virgen del • Northwestern University • CHU de Lille Rocío • Roswell Park • CHU de Nantes - Hôtel Dieu • Indiana University • UCLA •

  15. Slide 15: Author List

    Author List Amir T. Fathi1, Eunice S. Wang2, Ghayas C. Issa3, Jessica K. Altman4, Pau Montesinos5, Stephane DeBotton6, Roland Walter7, Kristen Pettit8, Stephen Strickland9, Mrinal Patnaik10, Marina Kremyanskaya11, Maria R. Baer12, James Foran13, Gary Schiller14, Lionel Ades15, Mael Heiblig16, Celine

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