Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — J.P. Morgan Healthcare Conference 2020
27 slides from Kura Oncology's conference presentation, Jan 13, 2020
Slide 1: Developing Precision Medicines for the Treatment of Cancer
Developing Precision Medicines for the Treatment of Cancer J.P. Morgan Healthcare Conference January 13-16, 2020 Exhibit 99.1
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 tipifarnib, KO-947 and KO-539, plans regarding regu
Slide 3: Investment Highlights
* Includes cash, cash equivalents and short-term investments Investment Highlights Targeted Oncology Advancing pipeline of targeted drug candidates for selected solid tumors and hematologic malignancies Utilizing precision medicine approach; Fast-to-market strategy Proprietary Pipeline Tipifarnib: F
Slide 4: Kura Leadership Team and Board of Directors
Proven oncology drug discovery, development and commercialization expertise Kura Leadership Team and Board of Directors Leadership Team Troy Wilson, Ph.D., J.D. President and Chief Executive Officer Antonio Gualberto, M.D., Ph.D. Head of Development and Chief Medical Officer Marc Grasso, M.D. Chief
Slide 5: Product Candidate Pipeline
* Investigator-sponsored trials Product Candidate Pipeline Program Preclinical Phase 1 Phase 2 Pivotal Tipifarnib Farnesyl Transferase Inhibitor HRAS Mutant Indications CXCL12 Pathway Indications KO-947 ERK Inhibitor KO-539 Menin-MLL Inhibitor Head and Neck Squamous Carcinoma Urothelial Carcinoma* L
Slide 6: Tipifarnib (Farnesyl Transferase Inhibitor)
01 Tipifarnib (Farnesyl Transferase Inhibitor) 02 03 KO-539 (Menin-MLL Inhibitor) KO-947 (ERK Inhibitor)
Slide 7: Farnesyl Transferase Inhibitors: A Leadership Opportunity in Targeted Oncology
Farnesyl Transferase Inhibitors (FTIs): A Leadership Opportunity in Targeted Oncology Lifecycle expansion opportunities with validated biomarkers in multiple solid and liquid tumors Kura is building an exclusive position for the research, development and commercialization of tipifarnib and FTIs Acce
Slide 8: Tipifarnib: A First-in-Class Farnesyl Transferase Inhibitor for the Treatment of Cancer
Potent, selective inhibitor of farnesyl transferase1 Well characterized with > 5,000 patients treated Durable responses previously reported in selected study patients, but appropriate genetic biomarkers were not identified at that time Kura scientists discovered proprietary biomarkers (HRAS and CXCL
Slide 9: FTIs Inhibit Two Distinct Critical Pathways
CXCL12 and its receptors (CXCR4, CXCR7) link cancer cells to the tumor microenvironment CXCL12 pathway activation drives cancer phenotype; poor prognosis Tipifarnib inhibits farnesylation of key regulatory proteins involved in CXCL12 production HRAS mediates signal transduction and growth and prolif
Slide 10: Registration Strategy in HRAS Mutant HNSCC
1 Ho et al. AACR-NCI-EORTC #384 (preliminary data as of 10/17/19) 2 Feedback from end-of-Phase 2 meeting with FDA Registration Strategy in HRAS Mutant HNSCC: Potential for Accelerated Approval HNSCC represents a significant unmet need as standard of care (SOC) provides limited clinical benefit in OR
Slide 11: Proof-of-Concept in Urothelial Carcinoma
Dr. Se Hoon Park, Samsung Medical Center (unpublished data) Proof-of-Concept in Urothelial Carcinoma Demonstrates Potential for Label Expansion HRAS Mutant Urothelial Carcinoma Potential for Label Expansion in HRAS Mutant Tumors HNSCC Earlier lines of therapy: 1st line combination with SOC I/O and a
Slide 12: FTIs Inhibit Two Distinct Critical Pathways
CXCL12 and its receptors (CXCR4, CXCR7) link cancer cells to the tumor microenvironment CXCL12 pathway activation drives cancer phenotype; poor prognosis Tipifarnib inhibits farnesylation of key regulatory proteins involved in CXCL12 production HRAS mediates signal transduction and growth and prolif
Slide 13: Registration Strategy in AITL: Single-Arm ORR Trial
Witzig et al. ASH 2019 #468 (preliminary data as of 11/11/19) Registration Strategy in AITL: Single-Arm ORR Trial Provides Potential for Accelerated Approval ORR (PPS): 50% Median DOR: 6.6 months Phase 2 Study in Angioimmunoblastic T-Cell Lymphomas AITL represents a significant unmet need as SOC pro
Slide 14: Proof-of-Concept in AITL/CXCL12-High PTCL
Gualberto et al. AACR 2019 #CT191 Proof-of-Concept in AITL/CXCL12-High PTCL Demonstrates Potential for Label Expansion Diffuse Large B-Cell Lymphoma Phase 2 PTCL study shows potential to utilize CXCL12 to enrich for clinical activity Retrospective analyses demonstrate association between CXCL12 path
Slide 15: Potential for Label Expansion in Pancreatic Cancer
Potential for Label Expansion in CXCL12-Dependent Solid Tumors: Pancreatic Cancer 1 Samarendra, et al. Br J Cancer. 2017;117:124–15 2 Gualberto et al. JCO 2019. 37, suppl: 275 (gene expression data from TCGA) 3 Kura Oncology, data on file Rationale High CXCL12 expression is associated with reduced o
Slide 16: Tipifarnib: Broad Potential Market Expansion Opportunity
Indication Patients* Angioimmunoblastic T-cell lymphoma (AITL) & AITL-like histologies*** 1,300+ Acute myeloid leukemia (AML) 6,400+ Diffuse large B-cell lymphoma (DLBCL) 9,000+ Pancreatic 17,000+ Indication Patients* Head & neck squamous cell carcinomas (HNSCC)** 2,900+ Urothelial carcinomas 4,600+
Slide 17: Tipifarnib / FTI Patent Exclusivity
Tipifarnib / FTI Patent Exclusivity Patents cover combinations of tipifarnib with other agents (e.g., I/O) Additional patents possible with specific agents, doses, schedules, etc. Multiple issued U.S. patents covering biomarker-guided indications (e.g., HRAS mutant HNSCC, CXCL12-expressing PTCL) and
Slide 18: KO-947 (ERK Inhibitor)
KO-539 (Menin-MLL Inhibitor) 03 01 Tipifarnib (Farnesyl Transferase Inhibitor) 02 KO-947 (ERK Inhibitor)
Slide 19: KO-947: Potent Inhibitor of ERK1/2
Potent, selective small molecule inhibitor of ERK1/2 Demonstrates prolonged pathway modulation in preclinical tumor models Multiple tumors, including molecularly-defined squamous cell carcinomas and adenocarcinomas, identified as sensitive to KO-947 as monotherapy in preclinical models Mechanism-bas
Slide 20: KO-947 Demonstrates Robust Single-Agent Activity in Preclinical Studies
Burrows et al. AACR 2017 #5168/11 KO-947 Demonstrates Robust Single-Agent Activity in Preclinical Studies Broad profiling in ~ 200 patient-derived xenograft (PDX) models Consistent and compelling activity in diverse indications on intermittent schedules Robust activity in preclinical models of HNSCC
Slide 21: KO-947: Phase 1 Clinical Trial
First-in-human study in patients with advanced solid tumors Currently evaluating two dosing regimens, including once-weekly dosing and a more frequent intermittent schedule Dose-escalation objectives: Determine recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) Investigate safety an
Slide 22: KO-539 (Menin-MLL Inhibitor)
01 Tipifarnib (Farnesyl Transferase Inhibitor) 03 KO-539 (Menin-MLL Inhibitor) KO-947 (ERK Inhibitor) 02
Slide 23: KO-539: Potent Inhibitor of Menin-MLL Interaction
1 N Engl J Med. 2012 Mar 22;366(12):1079-89 | Haematologica. 2007 Jun;92(6):744-52 | Anticancer Res. 2005 May-Jun;25(3B):1931-44 Potent, selective small molecule inhibitor of the menin-MLL protein-protein interaction Robust antitumor activity observed in mixed lineage leukemias rearranged (MLL-r) as
Slide 24: KO-539 Produces Lasting Complete Remissions in AML Model
Burrows et al. AACR-NCI-EORTC 2017 LB-A27 KO-539 Produces Lasting Complete Remissions in a NPM1 / DNMT3A / IDH2 / FLT3-Mutant AML Model 100% (10/10) of animals treated with single-agent KO-539 cleared their leukemia and became long-term survivors Tumor growth inhibition was durable – no leukemia was
Slide 25: KO-539: Phase 1 Clinical Trial
First-in-human study in patients with relapsed/refractory AML First patient dosed in September 2019 Administered as a once daily oral dose in 28-continuous-day cycles Dose escalation objectives: Determine recommended Phase 2 dose and/or MTD Investigate safety and tolerability Characterize pharmacoki
Slide 26: Forecasted Milestones & Financial Highlights
* As of September 30, 2019 Forecasted Milestones & Financial Highlights Program Milestone Status Tipifarnib Farnesyl Transferase Inhibitor HRAS Mutant Indications Data from Phase 2 trial in urothelial carcinoma 2020 Potential for full enrollment in AIM-HN Q1 2021 CXCL12 Pathway Indications Data from
Slide 27: Developing Precision Medicines for the Treatment of Cancer
Developing Precision Medicines for the Treatment of Cancer
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