DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER
ASH Investor Event - December 10, 2022
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 expectations regarding the relative benefits of our product candidates versus competitive therapies, and our expectations regarding the therapeutic and commercial potential of our
product candidates. The words "believe," "may," "should," "will," "estimate," "promise," "plan", "continue," "anticipate," "intend," "expect," "potential" and similar
expressions (including the negative thereof), are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: our preclinical studies and clinical trials may not be successful; the U.S. Food and Drug Administration (FDA) may not agree with our interpretation of the data from clinical trials of our product candidates; we may decide, or the FDA may require us, to conduct additional clinical trials or to modify our ongoing clinical trials; we may experience delays in the commencement, enrollment, completion or analysis of clinical testing for our product candidates, or significant issues regarding the adequacy of our clinical trial designs or the execution of our clinical trials may arise, which could result in increased costs and delays, or limit our ability to obtain regulatory approval; the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; our product candidates may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of our product candidates could delay or prevent regulatory approval or commercialization; and we may not be able to obtain additional financing. Additional risks and uncertainties may emerge from time to time, and it is not possible for Kura's management to predict all risk factors and uncertainties.
All forward-looking statements contained in this presentation speak only as of the date on which they were made. Other risks and uncertainties affecting us are described more fully in our filings with the Securities and Exchange Commission. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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 |
Unmet need in AML / Summary of Phase 1a | Eunice Wang, M.D., Roswell Park Comprehensive Cancer Center |
Presentation of KOMET-001 Phase 1b Data | Harry Erba, M.D., Ph.D., Duke University School of Medicine |
Regulatory Feedback / Next Steps | Stephen Dale, M.D., Chief Medical Officer |
Ziftomenib Clinical Development Path | Mollie Leoni, M.D., Senior Vice President, Clinical Development |
Q & A session | All |
Upcoming Milestones / Closing Remarks | Troy Wilson, Ph.D., J.D., President and Chief Executive Officer |
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KOMET-001 Investigators
Eunice Wang, M.D.
-
Chief of the Leukemia Service at Roswell Park
Comprehensive Cancer Center - Associate Professor, Department of Medicine, State University of New York at Buffalo
Harry Erba, M.D., Ph.D.
- Clinical Investigator in the Division of Hematologic Malignancies and Cellular Therapy, Duke University School of Medicine
- Director of the Leukemia Program and Director of Phase I Development in Hematologic Malignancies
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NPM1-mutant and KMT2A-rearranged AML Represent
Areas of Significant Unmet Need
No FDA-Approved Targeted Therapies Exist Today
NPM1-mutant AML | KMT2A-rearranged AML | ||
~ 6,000 new cases annually in the U.S.1 | ~ 1,000-2,000 new cases annually in U.S.1 |
30% | 5-10% |
AML | AML |
Adult patients with NPM1-mutant AML and select | Adult patients with KMT2A-rearranged AML have | |||
co-mutations and/or relapsed/refractory disease are | poor prognosis with high rates of resistance and | |||
associated with poor prognosis2 | relapse following current standard of care 5, 6 | |||
5-year Overall Survival ~50%3 | ||||
5-year Overall Survival <20%5 | ||||
Median Overall Survival in patients with R/R | Median Overall Survival in patients with R/R | |||
NPM1 AML is ~6.1 mo.4 | KMT2A-r AML is 6 mo. following 2L treatment | |||
and 2.4 mo. following 3L treatment5 | ||||
1 SEER statistics for AML in the US, accessed April 2020. | 4. Venugopal S, et al. ASH Abstract 2287, 2021. | 5 | ||
2 Döhner et al. Blood. 2017 Jan 26;129(4):424-447. | 5 Issa GC, et al. Blood Cancer J. 2021;11(9):162. | |||
3 Angenendt L, et al. J Clin Oncol. 2019;37(29):2632-2642. | 6 Vetro C, et al. Cancer Genet. 2020;240:15-22. .. | |||
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Kura Oncology Inc. published this content on 10 December 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 December 2022 17:22:02 UTC.