Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — EHA Investor Event 2023
22 slides from Kura Oncology's conference presentation, Jun 12, 2023
Slide 1: EHA Investor Event – June 12, 2023
EHA Investor Event – June 12, 2023 DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Exhibit 99.1
Slide 2: 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 regulatory filings, our ex
Slide 3: Today's Agenda
Today’s Agenda Topic Speaker Welcome / Opening Remarks Troy Wilson, Ph.D., J.D., President and Chief Executive Officer Introduction of KOMET-001 Investigators Stephen Dale, M.D., Chief Medical Officer Opportunity in AML / KOMET-001 Trial Design Ghayas Issa, M.D., MD Anderson Cancer Center Presentati
Slide 4: Ziftomenib Represents a Transformational Therapy for AML
Demonstrated clinical activity in other AML subtypes beyond NPM1-m and KMT2A-r to broaden patient potential Ziftomenib Represents a Transformational Therapy for AML Rationale for ziftomenib as a highly durable and well-tolerated maintenance therapy to transform acute leukemias into a chronic disease
Slide 5: KOMET-001 Investigators
KOMET-001 Investigators Program Director, Center for Leukemia, Massachusetts General Hospital Cancer Center Associate Professor of Medicine, Harvard Medical School Amir Fathi, M.D. Hematology & Oncology, Departments of Leukemia and Genomic Medicine, MD Anderson Cancer Center Assistant Professor, Dep
Slide 6: NPM1-mutant AML is a Large Genetic Subset with a High Unmet Need
AML, acute myeloid leukemia; NPM1-m, nucleophosmin1-mutations; OS, overall survival; R/R, relapsed/refractory. 1. Döhner et al. Blood 2017;129(4):424-47; 2. SEER statistics for AML in the US, accessed April 2020; 3. Angenendt L, et al. J Clin Oncol 2019;37(29):2632-42; 4. Issa G, et al. Blood Adv 20
Slide 7: Ziftomenib Targets the Menin-KMT2A Pathway, a Foundational Target in AML
Ziftomenib Targets the Menin-KMT2A Pathway, a Foundational Target in AML 1. Lu et al. Cancer Cell 2016;30(1):92–107; 2. Ferreira et al. Oncogene 2016;35(23):3079-82; 3. Jeong et al. Nat. Genet 2014;46(1):17-23; 4. Wang et al. Blood 2005;106(1):254–64; 5. Chowdhury et al. EMBO Rep 2011;12(5):463-9;
Slide 8: KOMET-001 Phase 1/2 Study of Ziftomenib in Relapsed/Refractory AML
KOMET-001 Phase 1/2 Study of Ziftomenib in Relapsed/Refractory AML CR, complete remission; CRh, complete remission with partial hematological recovery; FDA, United States Food and Drug Administration; MRD, measurable residual disease; R/R, relapsed/refractory; RP2D, recommended phase 2 dose. Phase 1
Slide 9: Ziftomenib Demonstrates Encouraging Safety Profile in NPM1-mutant Patients
Ziftomenib Demonstrates Encouraging Safety Profile in NPM1-mutant Patients Treated at 600 mg Dose Fathi et al. EHA 2023 #LB2713 (preliminary data as of April 12, 2023) ≥ 20% Treatment-Emergent Adverse Events, n (%) NPM1-m, n = 20 Patients with TEAEs (All Grades) 19 (95) Diarrhea 9 (45) Hypokalemia 8
Slide 10: Ziftomenib Demonstrates Encouraging Clinical Activity
Ziftomenib Demonstrates Encouraging Clinical Activity CR Rates vs. SOC in Heavily Pretreated Patients MUTATION CR % mDOR MEDIAN PRIORS Ziftomenib 600mg QD NPM1m 35% 8.2 mo* 3 FLT3m 33% - IDH 1/2 57% - Gilteritinib FLT3m 14.2% 14.8 mo 1 Enasidenib IDH2 19% 8.2 mo 2 Ivosidenib IDH1 25% 10.1 mo 2 *Medi
Slide 11: Ziftomenib Drives Durable CRs with Maintained Count Recovery
Ziftomenib Drives Durable CRs with Maintained Count Recovery as a Monotherapy in Late-Line NPM1-mutant AML Patients 1 NPM1-m CRc Responders Mean Change in Platelets and ANC up to C7D1 Maintained count recovery after durable CRs suggests no drug-induced myelosuppression Excellent safety profile and
Slide 12: Ziftomenib Monotherapy Drives Durable Responses
Ziftomenib Monotherapy Drives Durable Responses 2 Fathi et al. EHA 2023 #LB2713 (preliminary data as of April 12, 2023) 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 t
Slide 13: Meaningful Durability and Favorable Tolerability at 600 mg Dose
Meaningful Durability and Favorable Tolerability at 600 mg Dose 22 yo male with NPM1-m AML 1 Prior Tx (refractory to 7+3) Baseline bone marrow blasts: 90% ziftomenib at 600 mg Response CRmrd- after Cycle 1 HSCT CRmrd- maintained on Cycle 2 post-HSCT 44 yo female with NPM1-m, DNMT3A and IKZF1 AML 7 P
Slide 14: Rationale to Sequence Ziftomenib Ahead of Other Targeted Therapies
Rationale to Sequence Ziftomenib Ahead of Other Targeted Therapies * Mutations detected in MyMRD NGS (Invivoscribe, San Diego, CA) Ziftomenib drives CR and brings co-mutations down to near undetectable levels following failure with midostaurin and sequenced ahead of IDH1 inhibitor Ziftomenib drives
Slide 15: Targeting the Menin-KMT2A Pathway Has Potential to Benefit a Broader Subset of AML Patients
SETD2/RUNX1 patient achieved a CR at 100mg dose in Phase 1a Notable evidence of blast reduction in range of off-target patients KOMET-001 study will continue to evaluate additional AML populations Potential to be incorporated into KOMET-007/008 combination studies Targeting the Menin-KMT2A Pathway h
Slide 16: Ziftomenib Active Against Known Menin Gatekeeper Mutations
Ziftomenib Active Against Known Menin Gatekeeper Mutations 1Perner et al. Abstract #3457 presented at AACR April 14-19, 2023, Orlando, FL. No major conformational changes observed in MeninT349M vs. wild-type (WT) protein M327 and Y324 side chains adopt new conformations in MeninT349M but do not aff
Slide 17: Ziftomenib Appears Less Susceptible to Mutations Associated With Resistance
Ziftomenib Appears Less Susceptible to Observed Mutations Associated With Resistance to Menin Inhibition 1 Perner et al. Nature 2023; 615(7954):913-19. 2MEN1 mutant transcripts detected from serial analysis of bone marrow aspirate (BMA) of patients treated with at least 1 cycle of ziftomenib using R
Slide 18: Summary: KOMET-001 Phase 1b Clinical Trial of Ziftomenib
Summary: KOMET-001 Phase 1 Clinical Trial of Ziftomenib Fathi et al. EHA 2023 #LB2713 (preliminary data as of April 12, 2023) Ziftomenib demonstrates significant clinical activity with 45% ORR (35% CR rate) and non-myelosuppressive with maintained count recovery in heavily pretreated R/R NPM1-m AML
Slide 19: Ziftomenib Clinical Development Path
DEVELOPMENT APPROACH STUDY STARTUP PHASE 1 REGISTRATION DIRECTED TRIAL MONOTHERAPY (Relapsed/refractory) COMBINATIONS WITH VENETOCLAX + AZACITIDINE, CYTARABINE + DAUNORUBICIN (7+3) (Relapsed/refractory, frontline) COMBINATIONS WITH GILTERITINIB, FLAG-IDA, LDAC (Relapsed/refractory) POST-TRANSPLANT M
Slide 20: Ziftomenib Represents 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, ideal for chronic therapy Strong mechanistic synergy with current standards of
Slide 21: Q & A
Q & A
Slide 22: EHA Investor Event – June 12, 2023
EHA Investor Event – June 12, 2023 DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER