Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — Technical Presentation (June 2019)
21 slides from Kura Oncology's technical presentation, Jun 14, 2019
Slide 1: EHA Data Review: Developing Precision Medicines for the Treatment of Cancer
Exhibit 99.2 Developing Precision Medicines for the Treatment of Cancer EHA Data Review June 14, 2019Exhibit 99.2 Developing Precision Medicines for the Treatment of Cancer EHA Data Review June 14, 2019
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: Agenda for Today's Call
Agenda for Today’s Call 1) Introduction / Background 2) Data from Positive Phase 2 Trial of Tipifarnib in PTCL – EHA 2019 3) Opportunities to Expand to Additional CXCL12-Driven Indications 4) Upcoming Milestones 5) Q & A 3Agenda for Today’s Call 1) Introduction / Background 2) Data from Positive Pha
Slide 4: Kura Oncology – Key Themes
Kura Oncology – Key Themes • Targeted therapies remain an essential category for new drug development in oncology • Enhanced clinical benefit in selected patient populations • Displacement of existing therapies and becoming part of the standard of care in a population of high unmet need • Rationale
Slide 5: Discovery of Tipifarnib as a First-in-Class CXCL12 inhibitor that Achieved Clinical POC
Discovery of Tipifarnib as a First-in-Class CXCL12 inhibitor that Achieved Clinical POC • AITL and CXCL12 3’UTR SNP cohorts achieved clinical POC • Validation of robust clinical markers of sensitivity to tipifarnib Witzig et al. EHA 2019 #S869 • Definition of patient subsets with exceptional activit
Slide 6: PTCL / AITL Trial Design
PTCL / AITL Trial Design Investigator-Sponsored Phase 2 Trial of Tipifarnib in Study of Tipifarnib in Relapsed/Refractory PTCL Relapsed/Refractory 1 (KO-TIP-002) Lymphomas Unselected Patients (N=18) Three responses, including 2 2 responses among 3 AITL patients Expansion Cohort 1 Expansion Cohort 2
Slide 7: Tipifarnib in Relapsed or Refractory AITL and CXCL12+ PTCL: Preliminary Results
Tipifarnib in Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma (AITL) and CXCL12+ Peripheral T-cell Lymphoma (PTCL): Preliminary Results from an Open-Label, Phase 2 Study 1 2 3 4 5 6 Thomas Witzig , Lubomir Sokol , Won Seog Kim , Francine Foss , Eric Jacobsen , Fatima de la Cruz Vicente , 7
Slide 8: Tipifarnib is a CXCL12/CXCR4 Pathway Inhibitor
Tipifarnib is a CXCL12/CXCR4 Pathway Inhibitor • Key characteristics of CXCL12 – Expressed primarily by immune cells, endothelial cells and stromal fibroblasts that constitute the tumor microenvironment – CXCL12 and its receptors (CXCR4, CXCR7) are key factors linking cancer cells with the tumor mic
Slide 9: Proof of Concept for Tipifarnib in wt CXCL12 3'UTR PTCL
Proof of Concept for Tipifarnib in wt CXCL12 3’UTR PTCL wt CXCL12 3’UTR Cohort: wt CXCL12 3’UTR Cohort: wt CXCL12 3’UTR Cohort: All pts AITL pts PTCL-NOS pts Total treated 15 4 11 12 3 9 Total efficacy evaluable Overall Best Response Complete Response (CR) 3 2 1 Partial Response (PR) 2 - 2 6 - 6 Sta
Slide 10: Enrichment by wt CXCL12 3'UTR PTCL-NOS
Enrichment by wt CXCL12 3’UTR PTCL-NOS All PTCL-NOS All PTCL-NOS 1 2 wt CXCL12 3’UTR Variant CXCL12 3’UTR 17 6 Total treated 15 6 Total efficacy evaluable Overall Best Response Complete Response (CR) 1 - Partial Response (PR) 2 - 10 - Stable Disease (SD) 2 6 Progressive Disease (PD) 2 - Not efficacy
Slide 11: Tumor Reduction in PTCL-NOS, wt CXCL12 3'UTR
Tumor Reduction in PTCL-NOS, wt CXCL12 3’UTR • 77 yo male with PTCL-NOS Stage IV • CHOP x 5 with initial response then progression in skin • At baseline visit had multiple skin nodules biopsy proven relapsed PTCL • After two cycles of tipifarnib patient had near CR Baseline End of Cycle 2 th 24 Cong
Slide 12: Proof of Concept for Tipifarnib in AITL
Proof of Concept for Tipifarnib in AITL 1 AITL Cohort All AITL 16 Total treated 23 11 Total efficacy evaluable 17 Overall Best Response 3 Complete Response (CR) 5 Partial Response (PR) 2 4 3 3 Stable Disease (SD) 3 Progressive Disease (PD) 5 Not efficacy evaluable (NE) 5 6 2 2 PPS mITT PPS mITT Over
Slide 13: AITL: Durable clinical responses enabled subsequent transplant
AITL: Tipifarnib treatment resulted in durable clinical responses and enabled subsequent transplant in patients achieving a CR Maximum Change in Tumor Burden Time on Treatment 40 20 0 -20 Allo BMT -40 Median 5.5 months (95% CI 3.7-30.6) for AITL patients with SD/PR/CR Allo BMT -60 -80 -100 -120 Meas
Slide 14: Tipifarnib is Active in High CXCL12 Expressing AITL and PTCL NOS Tumors
Tipifarnib is Active in High CXCL12 Expressing AITL and PTCL NOS Tumors sample HISTOL RESP CXCL12/CXCR4 6 AITL PR 7.42 Maximum Change in Tumor Burden 28 AITL CR 2.4 AITL PD/NE 1.5 34 NOS SD 1.3 36 40 17 NOS SD 0.85 Tipifarnib targets 32 AITL PD/NE 0.8 NOS SD 0.6 37 CXCL12 and is active in AITL CR 0.
Slide 15: High Activity of Tipifarnib in AITL with KIR3DL2 mutations
High Activity of Tipifarnib in AITL with KIR3DL2 mutations Best Response to Tipifarnib (N=16 AITL with sequenced tumors) • CXCL12 and CXCL5 drive, respectively, KIR3DL2 Mutant KIR3DL2 Wild Type sensitivity and resistance to tipifarnib. N 8 8 • AITL expresses high levels of CXCL12 and Overall Best Re
Slide 16: Drivers of Tipifarnib's Activity in AITL
Drivers of Tipifarnib’s Activity in AITL Overall high CXCL12 expression in AITL, Low CXCL5 expression in KIR3DL2 mutant AITL Genetics Mechanism of Action Activity High CXCL12 expression in AITL histology Tipifarnib downregulates CXCL12 secretion Histology 100000 AITL DMSO Tipifarnib NOS (control) 10
Slide 17: Conclusions
Conclusions • The AITL and wt CXCL12 3’UTR cohorts met pre-specified statistical hypotheses supporting proof-of-concept for tipifarnib in PTCL. • Tipifarnib is active in AITL pts and in PTCL-NOS pts with wt CXCL12 3’UTR – AITL: 53% ORR (all subjects, PPS) – PTCL-NOS with wt CXCL12 3’UTR: 20% ORR (al
Slide 18: Tipifarnib Has Potential to Expand to Additional CXCL12-High Populations
Tipifarnib Has Potential to Expand to Additional CXCL12-High Populations ~40% ~33% 5 5 Est. Annual U.S. Incidence: 3,950 Est. Annual U.S. Incidence: 27,650 ~30% ~30% 6 6 Est. Annual U.S. Incidence: 21,450 Est. Annual U.S. Incidence: 56,770 1 2 3 4 Witzig ASH 2018 #2937 | Kura Oncology ASH 2018 Data
Slide 19: Key Takeaways
Key Takeaways • POC achieved in AITL and wt CXCL12 3’UTR extension cohorts • AITL and related lymphomas represent approximately one-third of PTCL cases • KIR3DL2 and CXCL12 genotype provide additional robust tools for the selection/stratification of PTCL patients • Approximately 50% of AITL carries
Slide 20: Anticipated Milestones & Financial Highlights
Anticipated Milestones & Financial Highlights Phase 1 Program Milestones Status HRAS Initiation of registration-direct1ed trial in HNSCC ü Mutant Additional data from Phase 2 trial in HNSCC and other SCCs 2H 2019 Indications Tipifarnib Patents for tipifarnib in AITL and CXCL12+ PTCL/AML ü Farnesyl T
Slide 21: Developing Precision Medicines for the Treatment of Cancer
Developing Precision Medicines for the Treatment of CancerDeveloping Precision Medicines for the Treatment of Cancer