Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — Technical Presentation (January 2024)
31 slides from Kura Oncology's technical presentation, Jan 30, 2024
Slide 1: Preliminary Data from KOMET-007
Exhibit 99.1 DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Preliminary Data from KOMET-007 – January 30, 2024
Slide 2: Welcome and Introduction
WELCOME AND INTRODUCTION Troy Wilson, Ph.D., J.D. – President & Chief Executive Officer, Kura Oncology
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for ziftomenib, tipifarnib and KO-2806, plans regarding
Slide 4: Targeting Foundational Mutations: Acute Promyelocytic Leukemia
Targeting Foundational Mutations has Transformed Deadly Hematologic Cancers into Chronic Diseases Acute Promyelocytic Leukemia Acute Promyelocytic Leukemia (APL) • APL arises from an abnormal fusion protein called PML/RARα, which is mechanistically similar to the menin-KMT2A complex in AML. • ATRA/A
Slide 5: Targeting Foundational Mutations: Multiple Myeloma
Targeting Foundational Mutations has Transformed Deadly Hematologic Cancers into Chronic Diseases Multiple Myeloma • Until the 2000’s, there were few treatment options for multiple myeloma, and the median survival was 2–3 years. • With the advent of immunomodulatory drugs (IMiDs) and proteasome inhi
Slide 6: Ziftomenib Opportunity and Introduction to KOMET-007 Investigators
ZIFTOMENIB OPPORTUNITY AND INTRODUCTION TO KOMET-007 INVESTIGATORS Stephen Dale, M.D. – Chief Medical Officer, Kura Oncology
Slide 7: Ziftomenib Demonstrates Potential to Become a Cornerstone of AML Therapy
Ziftomenib Demonstrates Potential to Become a Cornerstone of AML Therapy Targets foundational mutations at the core of up to 50% of AML cases • Compelling clinical data support frontline opportunity • Good tolerability profile, enabling continuous administration in combination with SOC • Combination
Slide 8: KOMET-007 Investigators
KOMET-007 Investigators Amir Fathi, M.D. Amer Zeidan, MBBS • Program Director, Center for Leukemia, • Interim Chief, Division of Hematologic Massachusetts General Hospital Cancer Center Malignancies, Director of Hematology Early Therapeutics Research, Yale Cancer Center • Associate Professor of Medi
Slide 9: Ziftomenib as Monotherapy / Opportunity in Combination
ZIFTOMENIB AS MONOTHERAPY / OPPORTUNITY IN COMBINATION Amir Fathi, M.D. – Massachusetts General Hospital
Slide 10: KOMET-001 Phase 1/2 Study of Ziftomenib in Relapsed/Refractory AML
KOMET-001 Phase 1/2 Study of Ziftomenib in Relapsed/Refractory AML Phase 1a Phase 1b Phase 2 Phase 1b Dose Escalation Expansion Registration-Enabling Validation Cohorts (Ongoing) Completed Completed Completed Ongoing Expansion of 600 mg QD Cohort 1: 200 mg QD 50 mg 100 mg 1000 mg 600 mg QD QD QD QD
Slide 11: Dose-Proportional Increase in Ziftomenib Exposure Supports 600 mg Dose
Dose-Proportional Increase in Ziftomenib Exposure Supports 600 mg Dose AUC = area under the curve 11
Slide 12: Ziftomenib Demonstrates Encouraging Safety Profile in Phase 1b
Ziftomenib Demonstrates Encouraging Safety Profile in Phase 1b • Differentiation syndrome (DS) appears manageable in NPM1-m monotherapy patients with mitigation strategy • 20% rate of mild to moderate DS • Rates of DS in KMT2A-r monotherapy patients were 38.5% at 200 mg and 37.5% at 600 mg; potentia
Slide 13: Ziftomenib has Highly Differentiated Monotherapy Activity
Ziftomenib has Highly Differentiated Monotherapy Activity Best Overall Response 600 mg Differentiated CR Rates vs. SOC in NPM1-m Phase 1a + 1b (n=20) 40% of NPM1 Heavily Pretreated Patients patients CR 7 (35.0) achieved a MEDIAN CR/CRh 7 (35.0) MUTATION CR % mDOR CR during PRIORS course of CRc 8 (40
Slide 14: Maximizing the Therapeutic Value of Menin Inhibitors Through Combinations
Maximizing the Therapeutic Value of Menin Inhibitors Will Come Through Combinations Clinical Activity – Enhanced relative to SOC Pharmacoeconomic Benefit – Safety/Tolerability – Minimal Fewer requirements for monitoring additive toxicity over SOC and hospitalization Quality of Life – Fewer Drug-Drug
Slide 15: Preliminary Combination Data from KOMET-007 Trial
PRELIMINARY COMBINATION DATA FROM KOMET-007 TRIAL Amer Zeidan, MBBS – Yale Cancer Center Disclosure: Honoraria or consultation fees provided by Kura Oncology
Slide 16: KOMET-007: Ziftomenib/Cytarabine/Daunorubicin Combination
KOMET-007: Phase 1 Combination Trial of Ziftomenib in Patients with Newly Diagnosed or R/R AML Ziftomenib/cytarabine/daunorubicin (7+3) combination • Ziftomenib dosing will begin on Cycle 1 Day 8 and be administered continuously thereafter • Cytarabine will be administered on C1 Day 1-7; administrat
Slide 17: KOMET-007: Ziftomenib/Venetoclax/Azacitidine Combination
KOMET-007: Phase 1 Combination Trial of Ziftomenib in Patients with Newly Diagnosed or R/R AML Ziftomenib/venetoclax/azacitidine combination • Ziftomenib dosing will begin on Cycle 1 Day 8 and be administered continuously thereafter • Venetoclax will be administered per label in 28-day cycles with a
Slide 18: KOMET-007: Patient Demographics and Disposition
KOMET-007: Patient Demographics and Disposition First 20 Patients Enrolled • Relapsed/refractory patients with NPM1-m or KMT2A-r AML in combination with venetoclax/azacitidine • Newly-diagnosed patients with adverse risk* NPM1-m or KMT2A-r AML in combination with cytarabine/daunorubicin (7+3) • 80%
Slide 19: KOMET-007: Promising Safety and Tolerability Profile in Combination
KOMET-007: Promising Safety and Tolerability Profile in Combination Combinations mitigate risk of differentiation syndrome (DS) Grade ≥ 3 TEAEs (≥ 10%) n (%) Grade ≥ 3 Ziftomenib-Related AEs (All) n (%) Patients with Grade ≥ 3 TEAEs 18 (90) Patients with Grade ≥ 3 Ziftomenib-Related AEs 6 (30) Plate
Slide 20: 100% CR Rate with Ziftomenib and 7+3 in 1L Adverse-Risk AML
100% CR rate with Ziftomenib and 7+3 in 1L Patients with Adverse-Risk AML* 1,2 • Anticipated CR/CRi rate with 7+3 in all-comer 1L adverse risk patients: 32-33% 1L Adverse-Risk Group CR Rate n=5 (n) Overall (NPM1-m + KMT2A-r) 100% (5) NPM1-m only (n=4) 100% (4) KMT2A-r only (n=1) 100% (1) • All patie
Slide 21: Ziftomenib + Ven/Aza in Menin Inhibitor Naïve Patients
Ziftomenib + Ven/Aza with Pronounced Activity in Menin Inhibitor Naïve Patients 1 • ~35-45% CR/CRi is expected in ven-naïve relapsed/refractory patients 2 • Anticipated response rate in KMT2A-r relapsed/refractory AML <10% ORR • 53% ORR in mITT population (n=15, including six menin experienced patie
Slide 22: Ziftomenib + Ven/Aza Drives Responses in Venetoclax Failures
Ziftomenib + Ven/Aza Able to Drive Responses in Venetoclax Failures 1-4 • Expected response rates following ven/aza ~ 0-20% 4 • Anticipated response rate in KMT2A-r R/R AML < 10% ORR Venetoclax Experienced Group ORR CR/CRi Rate CR/CRh Rate n=10 (n) (n) (n) Overall (NPM1-m + KMT2A-r) 40% (4) 30% (3)
Slide 23: Continued Use of Ziftomenib Following Successful Induction with 7+3
Continued Use of Ziftomenib Following Successful Induction with 7+3 HSCT ziftomenib CR 7+3 WEEK 0 1 6 23 CYT Cohort: Frontline Ongoing post-HSCT DAU NPM1-m 7+3 ZIFTO Patient Characteristics • CR after one cycle of induction (week 5-6) Demographics 66-year-old female Mutational profile NPM1m, CBL, ID
Slide 24: Ziftomenib Combinations Are Effective in Treating Aggressive Disease
Ziftomenib Combinations Are Effective in Treating Aggressive Disease ziftomenib Transition to R/R CR Relapse Cohort 7+3 WEEK 0 1 3 10 11 CYT Cohort: 1L KMT2A-r 7+3 DAU ZIFTO ziftomenib CRi HSCT Ven/Aza 6 WEEK 0 1 3 12 Cohort: R/R AZA KMT2A-r Ven/Aza VEN Ongoing post-HSCT ZIFTO Patient Characteristic
Slide 25: Ziftomenib Eliminates Extramedullary Disease in Heavily Pre-Treated Patient
Ziftomenib Eliminates Extramedullary Disease Unaffected by Prior Venetoclax in Heavily Pre-Treated Patient ziftomenib CRi CRh HSCT Ven/Aza 17 WEEK 0 1 4 8 10 AZA Cohort: R/R Ongoing post-HSCT VEN NPM1-m Ven/Aza ZIFTO C1D11: EMD “melted” within 2 days zifto start Patient Characteristics Prior lines o
Slide 26: Clinical Development Plan
CLINICAL DEVELOPMENT PLAN Mollie Leoni, M.D. – Executive Vice President, Clinical Development
Slide 27: Ziftomenib Clinical Development Path
Ziftomenib Clinical Development Path DEVELOPMENT APPROACH PLANNED STUDY STARTUP PHASE 1 REGISTRATION DIRECTED TRIAL NPM1-mutant acute myeloid leukemia (AML) MONOTHERAPY Non- NPM1-m/KMT2A-r AML (Relapsed/refractory) KMT2A-rearranged ALL COMBINATION WITH NPM1-mutant AML VENETOCLAX + AZACITIDINE KMT2A-
Slide 28: Market Opportunity and Upcoming Milestones
MARKET OPPORTUNITY AND UPCOMING MILESTONES Troy Wilson, Ph.D., J.D. – President & Chief Executive Officer, Kura Oncology
Slide 29: Ziftomenib Offers a Multi-Billion-Dollar Opportunity in AML and Beyond
Ziftomenib Offers a Multi-Billion-Dollar Opportunity in AML and Beyond Potential to Transform Outcomes Across the Continuum of Care • Initial approval represents 30% of potential patients Relapsed / • KOMET-001 registration-directed study for FDA full approval Refractory • Significant opportunity in
Slide 30: Upcoming Milestones for Ziftomenib in Acute Leukemia
Upcoming Milestones for Ziftomenib in Acute Leukemia ESTIMATED TIME MILESTONE OF ACHIEVEMENT Dose first patients in KOMET-008 trial in combination with FLT3 inhibitor gilteritinib, Q1 2024 LDAC and FLAG-IDA Initiate post-transplant maintenance program Q1 2024 Expand ziftomenib development to acute l
Slide 31: Developing Precision Medicines for the Treatment of Cancer
DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Preliminary Data from KOMET-007 – January 30, 2024
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