DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER
Corporate Presentation - November 2021
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-539 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.
Investment Highlights
Targeted Advancing targeted oncology drug candidates using a precision medicine Oncology approach; fast-to-market strategy; global commercial rights
KO-539
- Novel menin inhibitor with potential to target 35% or more of AML
- Encouraging safety, tolerability and clinical activity in multiple genetically defined subgroups of AML
Proprietary Pipeline
- Continued enrollment in Phase 1b expansion cohorts
Tipifarnib
- Breakthrough Therapy* and Fast Track Designations from FDA
- Registration-directedtrial in HRAS mutant HNSCC ongoing
- First clinical site activated in Phase 1/2 study with alpelisib in HNSCC
KO-2806
- Next-generationFTI program focused on delaying onset of drug resistance in large solid tumor indications
Strong | $543.4 million in cash** provides runway into 2024 | |
Financials | ||
* For the treatment of patients with recurrent or metastatic HRAS mutant HNSCC with | 3 | |
variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy |
** Cash, cash equivalents and short-term investments as of September 30, 2021
Kura Leadership Team and Board of Directors
Proven oncology drug development and commercialization expertise
Leadership Team
Troy Wilson, Ph.D., J.D.
President & Chief Executive Officer
Teresa Bair, J.D.
Chief Legal Officer
Stephen Dale, M.D.
Chief Medical Officer
Kirsten Flowers
Chief Commercial Officer
Kathleen Ford
Chief Operating Officer
Marc Grasso, M.D.
Chief Financial Officer & Chief Business Officer
Board of Directors
Troy Wilson, Ph.D., J.D. (Chairman)
President and CEO, Kura Oncology
Faheem Hasnain (Lead Director)
Chairman and Chief Executive Officer, Gossamer Bio
Helen Collins, M.D.
Former Chief Medical Officer, Five Prime Therapeutics
Thomas Malley
President, Mossrock Capital
Diane Parks
Former Head of U.S. Commercial, Kite Pharma
Carol Schafer
Former Vice Chair, Equity Capital Markets, Wells Fargo
Steven Stein, M.D.
Chief Medical Officer, Incyte
Mary Szela
President and CEO, TriSalus Life Sciences
4
KOMET-001: Phase 1/2 Clinical Trial of KO-539 in Patients with Relapsed or Refractory AML
Phase 1a | Phase 1b | Phase 2 | |||
Dose Escalation | Expansion Cohorts | Registration-Enabling | |||
Lower Dose: 200 mg | |||||
800 mg | Evaluate genetically | ||||
defined cohorts at RP2D | |||||
100 mg | Higher Dose: 600 mg | ||||
50 mg
OBJECTIVES
Dose escalation in all comer patients to establish MTD and/or recommended Phase 2 dose (RP2D)
- Safety and tolerability
- Pharmacokinetics
- Early evidence of anti- tumor activity
Enroll two genetically | Enroll genetically enriched | ||
enriched cohorts to enable | cohorts at RP2D for | ||
refinement of RP2D | registration | ||
• | Safety and tolerability | • | Primary endpoint: CR/CRh |
• | Pharmacokinetics | • | Safety and tolerability |
• | Anti-tumor efficacy | • | Other secondary and |
exploratory endpoints |
KOMET: Kura Oncology Menin-MLLTrial | 5 |
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Kura Oncology Inc. published this content on 04 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 November 2021 20:29:50 UTC.