Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — Q1 2024 Earnings Presentation
37 slides from Kura Oncology's earnings presentation, May 2, 2024
Slide 1: Developing Precision Medicines for the Treatment of Cancer
DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Corporate Presentation – May 2024
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 investigational therapies, forging new scientific and clinical paths to give Oncology patients a better chance for long-term, durable remissions Menin Inhibitor Program (Ziftomenib) • Potential to address up to 50% of acute leukemias throu
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 STUDY STARTUP DOSE-ESCALATION DOSE-VALIDATION REGISTRATION DIRECTED ANTICIPATED MILESTONE Complete enrollment of 85 NPM1-mutant acute myeloid leukemia (AML) patients by mid-2024 KOMET-001 KMT2A-rearranged acute Monotherapy Now dosing patients lymphoblas
Slide 6: Ziftomenib: Menin-KMT2A/MLL Inhibitor in Acute Leukemias
ZIFTOMENIB: MENIN-KMT2A/MLL INHIBITOR IN ACUTE LEUKEMIAS
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: 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
Slide 10: Ziftomenib Demonstrates Optimal Pharmaceutical Properties
Ziftomenib Demonstrates Optimal Pharmaceutical Properties Clinical data from KOMET-001 demonstrate: • Ziftomenib demonstrates a dose-dependent increase in exposure up to RP2D at 600 mg • Ziftomenib is not a clinically meaningful CYP3A4 substrate • No dose adjustment of ziftomenib needed when adminis
Slide 11: 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 12: Ziftomenib has Highly Differentiated Monotherapy Activity
Ziftomenib has Highly Differentiated Monotherapy Activity Best Overall Response 600 mg Differentiated CR Rates vs. SOC in 40% of NPM1 NPM1-m Phase 1a + 1b (n=20) Heavily Pretreated Patients patients CR 7 (35.0) achieved a CR during CR/CRh 7 (35.0) MUTATION CR % mDOR MEDIAN PRIORS course of CRc 8 (40
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: Targeting the Menin-KMT2A Pathway has Potential to 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 • SETD2/RUNX1 patient achieved a Baseline in Bone Marrow Blasts – mITT Phase 1a CR at 100
Slide 15: 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 16: KOMET-007: Phase 1 Combination Trial of Ziftomenib in Patients with Newly Diagnosed or R/R AML
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 begins on Cycle 1 Day 8 and be administered continuously thereafter • Cytarabine administered on Cycle 1 Day 1-7; administration of
Slide 17: KOMET-007: Phase 1 Combination Trial of Ziftomenib in Patients with Newly Diagnosed or R/R AML
KOMET-007: Phase 1 Combination Trial of Ziftomenib in Patients with Newly Diagnosed or R/R AML Ziftomenib/venetoclax/azacitidine combination • Ziftomenib dosing begins on Cycle 1 Day 8 and be administered continuously thereafter • Venetoclax administered per label in 28-day cycles with adjustments t
Slide 18: 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 19: 100% CR rate with Ziftomenib and 7+3 in 1L Patients with Adverse-Risk AML
100% CR rate with Ziftomenib and 7+3 in 1L Patients with Adverse-Risk AML* • Anticipated CR/CRi rate with 7+3 in all-comer 1L adverse risk patients: 32-33%1,2 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 patien
Slide 20: Ziftomenib + Ven/Aza with Pronounced Activity in Menin Inhibitor Naïve Patients
Ziftomenib + Ven/Aza with Pronounced Activity in Menin Inhibitor Naïve Patients • ~35-45% CR/CRi rate is expected in ven-naïve relapsed/refractory patients1 • Anticipated CR/CRi rate in KMT2A-r AML following two prior therapies <10%2 • 53% ORR in mITT population (n=15, including six menin experience
Slide 21: Ziftomenib + Ven/Aza Able to Drive Responses in Venetoclax Failures
Ziftomenib + Ven/Aza Able to Drive Responses in Venetoclax Failures • Expected response rates following ven/aza ~ 0-20%1-4 • Anticipated CR/CRi rate in KMT2A-r AML following two prior therapies < 10%5 Venetoclax Experienced Group ORR CR/CRi Rate CR/CRh Rate n=10 (n) (n) (n) Overall (NPM1-m + KMT2A-r
Slide 22: KOMET-008: Phase 1 Combination Trial of Ziftomenib in Patients with R/R AML
KOMET-008: Phase 1 Combination Trial of Ziftomenib in Patients with R/R AML Ziftomenib + gilteritinib combination • Phase 1a Dose Escalation • Arm A: Ziftomenib in combination with FLAG-IDA or LDAC or gilteritinib (illustrated above) in relapsed or refractory (R/R) NPM1-mutant AML • Arm B: Ziftomeni
Slide 23: Targeting Foundational Mutations has Transformed Deadly Hematologic Cancers into Chronic Diseases
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 24: We are 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 25: 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 • BTD granted in R/R NPM1-mu
Slide 26: Tipifarnib: Farnesyl Transferase Inhibitor (FTI)
TIPIFARNIB: FARNESYL TRANSFERASE INHIBITOR (FTI)
Slide 27: 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 28: 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 29: KURRENT-HN: Phase 1/2 Combination Trial of Tipifarnib and Alpelisib in Patients with 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 30: 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 31: KO-2806: Next-Generation FTI
KO-2806: NEXT- GENERATION FTI
Slide 32: Combination of KO-2806 and Cabozantinib Demonstrates Synergistic Activity in ccRCC CDX & PDX 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 cabozantinib in vivo IHC of 786-O tumors and quantitation • KO-2806 enhances the
Slide 33: 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 34: FIT-001 Phase 1 First-in-Human Clinical Trial of KO-2806 in Patients with 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 1A (COMBINATIONS) PART 1B (COMBINATIONS) DOSE ESCALATION DOSE ESCALATION DOSE EXPANSION OBJECTIVES Primary • Evaluate the safety and tolerability of KO-2806 (dose escalation) •
Slide 35: FTI Franchise Development Strategy
FTI Franchise Development Strategy Building on a strong KO-2806 in foundation with tipifarnib, KO- ccRCC and KRASG12C- 2806 and future FTIs are Tipifarnib in Mutant NSCLC (FIT-001) positioned for near-term value PIK3CA-dep HNSCC inflections, and could support (KURRENT-HN) Next-generation FTI to mult
Slide 36: Forecasted Milestones & Financial Highlights
Forecasted Milestones & Financial Highlights ESTIMATED TIME OF PROGRAM MILESTONE ACHIEVEMENT Dose first patients in non-NPM1m/non-KMT2A-r AML expansion cohort Dose first patients in KOMET-008 combination trial Initiate post-transplant maintenance program Receive Breakthrough Therapy Designatio
Slide 37: Developing Precision Medicines for the Treatment of Cancer
DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Corporate Presentation – May 2024