Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — Q3 2023 Earnings Presentation
33 slides from Kura Oncology's earnings presentation, Nov 2, 2023
Slide 1: Developing Precision Medicines for the Treatment of Cancer
DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Corporate Presentation – November 2023
Slide 2: 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 3: Investment Highlights
Investment Highlights Targeted Advancing a pipeline of novel therapies, forging new scientific and clinical paths to give patients a better Oncology chance for long-term durable remissions Menin Inhibitor Program (Ziftomenib) • Potential to address up to 50% of acute leukemias through monotherapy an
Slide 4: Experienced Leadership Team and Board of Directors
Experienced Leadership Team and Board of Directors Leadership Team Troy Wilson, Ph.D., J.D. Teresa Bair, J.D. Stephen Dale, M.D. Kathy Ford Brian Powl President & Chief Legal Officer Chief Medical Officer Chief Operating Officer Chief Commercial Officer Chief Executive Officer Pete De Spain Mollie L
Slide 5: Drug Candidate Pipeline
Drug Candidate Pipeline PROGRAM CLINICAL TRIAL PLANNED STUDY STARTUP PHASE 1 REGISTRATION DIRECTED NPM1-mutant acute myeloid leukemia (AML) KOMET-001 Monotherapy Non-NPM1-m/Non-KMT2A-r AML (Relapsed/ refractory) KMT2A-rearranged ALL KOMET-007 ZIFTOMENIB Combinations with NPM1-mutant AML Menin Inhibi
Slide 6: Ziftomenib: Menin-KMT2A/MLL Inhibitor in Acute Leukemias
ZIFTOMENIB: MENIN-KMT2A/MLL INHIBITOR IN ACUTE LEUKEMIAS
Slide 7: Ziftomenib Has Potential to Become a Transformational Therapy for AML
Ziftomenib Has Potential to Become a Transformational Therapy for AML • Targets foundational mutations at the core of up to 50% of AML cases • Has demonstrated durable CRs and maintained count recovery as a monotherapy in late-line AML patients • Favorable tolerability and once-daily oral dosing, id
Slide 8: 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
Slide 9: 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 1b Phase 2 Dose Escalation Validation Cohorts Expansion Registration-Enabling Completed Completed Completed (Ongoing) Ongoing Expansion of 600 mg QD 50 mg Cohort 1: 200 mg QD 100 mg 1000 mg 600 mg ~ ~ QD QD QD
Slide 10: Ziftomenib Demonstrates Encouraging Safety Profile in NPM1-mutant Patients
Ziftomenib Demonstrates Encouraging Safety Profile in NPM1-mutant Patients Treated at 600 Mg Dose ≥ 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 (6
Slide 11: Ziftomenib Has Highly Differentiated Monotherapy Activity
Ziftomenib Has Highly Differentiated Monotherapy Activity Best Overall Response, Ph.1b, 600 mg, n = 20 n (%) Differentiated CR Rates vs. SOC in 33% CR Heavily Pretreated Patients Complete remission rate (CR) 7 (35) co-FLT3m (N=6) CRc rate (CR+CRh+CRi) 8 (40) 50% CR 5 MEDIAN MUTATION CR % mDOR PRIORS
Slide 12: 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 on ziftomenib in CR (MRD-) through Cycle 36 • Patients 9 and 21 proceeded to HSCT • Patient 9 remains on ziftomenib for post-HSCT maintenance
Slide 13: Case Studies Highlight Meaningful Durability and Favorable Tolerability
Case Studies Highlight Meaningful Durability and Favorable Tolerability 44 yo female with NPM1-m, DNMT3A and IKZF1 AML 7 Prior Tx Baseline bone marrow blasts: 14% Durable CR for 36 cycles on ziftomenib in 8th line including 2 HSCTs ziftomenib at 200 mg • CRmrd- after Cycle 1 Response • CRmrd- throug
Slide 14: Rationale to Sequence Ziftomenib Ahead of Other Targeted Therapies
Rationale to Sequence Ziftomenib Ahead of Other Targeted Therapies Ongoing Central MRD Analysis, by NGS* Subject: Prior Tx with NPM1 FLT3-TKD IDH1 midostaurin Variant Allele Frequency (%) Ziftomenib drives CR and brings co- C1 D28 33 33 35 mutations down to near undetectable Not Not Not levels follo
Slide 15: Targeting the Menin-KMT2A Pathway Could Benefit a Broader Subset of AML Patients
Targeting the Menin-KMT2A Pathway has Potential to Benefit a Broader Subset of AML Patients Ziftomenib has Demonstrated Evidence of Activity in Non-NPM1-m/KMT2A-r Patients Off-Target Mutations: Best Change from Baseline in • SETD2/RUNX1 patient achieved a Bone Marrow Blasts – mITT Phase 1a CR at 100
Slide 16: Summary: KOMET-001 Phase 1 Clinical Trial of Ziftomenib
Summary: KOMET-001 Phase 1 Clinical Trial of Ziftomenib Ziftomenib demonstrates an encouraging safety profile and tolerability • Reported events most often consistent with features and manifestations of underlying disease • No evidence of drug-induced QTc prolongation • Differentiation syndrome, an
Slide 17: 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 COMBINATIONS WITH VENETOCLAX NPM1-mutant AML + AZACITIDINE, CYTA
Slide 18: KOMET-007: Phase 1 Combination Trial of Ziftomenib
KOMET-007: Phase 1 Combination Trial of Ziftomenib in Patients with Newly Diagnosed or R/R AML Preliminary data from KOMET-007 combination trial of ziftomenib anticipated in 1Q 2024 *Excluding partial tandem duplications. AE = adverse event; CR = complete remission; DLT = dose-limiting toxicity; SOC
Slide 19: KOMET-008: Phase 1 Combination Trial of Ziftomenib with Standards of Care
KOMET-008: Phase 1 Combination Trial of Ziftomenib with Standards of Care in Patients with R/R AML AE = adverse event; CR = complete remission; CRh = complete remission with partial hematologic recovery; DLT = dose-limiting toxicity; FLAG-IDA = fludarabine, cytarabine, granulocyte colony-stimulating
Slide 20: Investigating Ziftomenib Across the AML Continuum in up to 50% of Patients
We are Investigating Ziftomenib Across the AML Continuum in up to 50% of Patients for Whom Menin-KMT2A Pathway is a Disease Driver 1L Treatable Relapsed / Refractory ~17K ~14K Prevalence of Ziftomenib Eligible Patients Post- IC or NIC Tx Targeted Tx if Non-Intensive FIT IC* or Transplant/ Transplant
Slide 21: 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 / • ~ 8 months median OS on available R/R regimens in data to date Refractory • KOMET-001 registration-
Slide 22: Farnesyl Transferase Inhibitor Programs
FARNESYL TRANSFERASE INHIBITOR PROGRAMS
Slide 23: Therapeutic Applications of Farnesyl Transferase Inhibitors
Therapeutic Applications of Farnesyl Transferase Inhibitors • Dysregulated RAS-MAPK and PI3Ka/AKT/mTOR signaling are key drivers of various cancers. Targeted cancer therapies, such as alpelisib and adagrasib slow tumor progression by inhibiting individual elements in this complex signaling pathway.
Slide 24: Tipifarnib Shows Clinical Benefit in HRAS mutant HNSCC
Tipifarnib Shows Clinical Benefit in HRAS mutant HNSCC 1L 2L 3L+ Patients with High VAF in mITT (N=50) ORR by IRF: 7/24 ORR by IRF: 3/20 Investigator Independent 29% [0.13, 0.51] 15% [0.03, 0.38] Assessment Review Facility Best Overall Response, n (%) Confirmed CR 1 (2) 1 (2) Confirmed PR 14 (28) 9
Slide 25: KURRENT-HN: Phase 1/2 Combination Trial of Tipifarnib and Alpelisib in HNSCC
KURRENT-HN: PHASE 1/2 Combination Trial of Tipifarnib and Alpelisib in Patients with HNSCC Phase 1 clinical trial of tipifarnib and alpelisib in patients with recurrent/metastatic PIK3CA-amplified and/or PIK3CA-mutated HNSCC • Clinical collaboration to evaluate tipifarnib in combination with alpelis
Slide 26: Durable Clinical Response Observed in Patient with PIK3CA-dependent HNSCC
Durable Clinical Response Observed in Patient with PIK3CA-dependent HNSCC • 35yo, male, nonsmoker, HPV16 positive • SCC of tonsil Stage III cT4N2M0; PD-L1 CPS = 60 • Prior Treatments • CDDP/rad for 1 mo (Nov-Dec2019), BOR UNK • Cemiplimab/ISA101b (Jun-Nov2021), BOR PD • PIK3CA R88Q mutation (44%) an
Slide 27: Next-Generation Farnesyl Transferase Inhibitor (FTI)
Next-Generation Farnesyl Transferase Inhibitor (FTI) Tipifarnib KO-2806 Potency: Good Improved potency, Selectivity: Excellent pharmacokinetic and Dose: 600 mg physicochemical Frequency: BID properties • FTIs represent an attractive therapeutic and commercial opportunity in oncology with compelling
Slide 28: Combination of KO-2806 to Enhance Antitumor Efficacy of KRASG12C Inhibitor in NSCLC
Combination of KO-2806 to Enhance Antitumor Efficacy of KRASG12C Inhibitor in NSCLC Combination of KO-2806 with a KRASG12C Combination of KO-2806 with a KRASG12C inhibitor causes tumor regressions in patient- inhibitor suppresses mTOR and MAPK derived and cell-derived NSCLC xenografts signaling and
Slide 29: KO-2806 and Cabozantinib Demonstrate Synergistic Activity in ccRCC Models
Combination of KO-2806 and Cabozantinib Demonstrates Synergistic Activity in ccRCC CDX & PDX Models KO-2806 potentiates antitumor activity of KO-2806 enhances the anti-angiogenic cabozantinib in ccRCC models activity of axitinib in vivo IHC of 786-O tumors and quantitation • KO-2806 enhances the ant
Slide 30: FIT-001 Phase 1 First-in-Human Trial of KO-2806 in Advanced Solid Tumors
FIT-001 Phase 1 First-in-Human Clinical Trial of KO-2806 in Patients with Advanced Solid Tumors PART 1A (MONOTHERAPY) PART 1B (COMBINATIONS) PART 2 (COMBINATIONS) DOSE ESCALATION DOSE ESCALATION DOSE EXPANSION OBJECTIVES Primary • Evaluate the safety and tolerability of KO-2806 (dose escalation) • D
Slide 31: FTI Franchise Development Strategy
FTI Franchise Development Strategy Building on a strong FIT-001 foundation with tipifarnib, KO- (ccRCC and 2806 and future FTIs are KURRENT-HN KRASm) positioned for near-term value (PIK3CAm inflections, and could support HNSCC) Next-generation FTI to multiple approvals in large Additional Indication
Slide 32: Forecasted Milestones & Financial Highlights
Forecasted Milestones & Financial Highlights ESTIMATED TIME OF PROGRAM MILESTONE ACHIEVEMENT Preliminary data from 20 patients in KOMET-007 combination trial Q1 2024 Dose first patients in KOMET-008 combination trial Q1 2024 ZIFTOMENIB Menin Inhibitor Initiate the post-transplant maintenance program
Slide 33: Developing Precision Medicines for the Treatment of Cancer
DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Corporate Presentation – November 2023