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KURA CONCOLOGY Kura Oncology Reports First Quarter 2021 Financial Results May 6 , 2021 - Menin inhibitor KO - 539 continues to demonstrate compelling clinical activity , favorable safety / tolerability and a wide therapeutic window - - KOMET - 001 trial amended to include Phase 1b expansion cohorts enriched with NPM1 - mutant and KMT2A - rearranged relapsed / refractory AML patients - - Data from Phase 2 trial of tipifarnib in HRAS mutant head and neck squamous cell carcinoma highlighted in Journal of Clinical Oncology - - $ 603.9 million in cash , cash equivalents and investments provide runway into 2024 - - Management to host webcast and conference call today at 4:30 p.m. ET - SAN DIEGO , May 06 , 2021 ( GLOBE NEWSWIRE ) -- Kura Oncology , Inc. ( Nasdaq : KURA ) , a clinical - stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer , today reported first quarter 2021 financial results and provided a corporate update . " We believe KO - 539 is well - positioned as a potentially best - in - class and first - in - class menin inhibitor , " said Troy Wilson , Ph.D. , J.D. , President and Chief Executive Officer of Kura Oncology . " This confidence is supported by a growing body of clinical data , including compelling activity , a favorable safety and tolerability profile and a wide therapeutic window . As such , we intend to conduct a comprehensive clinical development strategy for KO - 539 , both as a monotherapy and in combination , aimed at providing the greatest benefit to patients with acute leukemia , and we are well funded to execute on this strategy . " " A critical component of our KO - 539 development plan is the determination of an optimal Phase 2 dose , " continued Dr Wilson . " Given the wide therapeutic window of KO - 539 , we have amended our KOMET - 001 trial to include two genetically enriched Phase 1b expansion cohorts . This should enable us to maximize the benefit - risk for KO - 539 in our target patient populations and better inform an optimal dose for Phase 2 and beyond . Enrollment in these Phase 1b expansion cohorts is expected to begin mid - year , and we look forward to sharing our progress as we work to bring this important therapeutic option to patients . " Recent Highlights • Enrollment in KOMET - 001 Phase 1b expansion cohorts to begin shortly - KO - 539 continues to demonstrate a wide therapeutic window and compelling single - agent activity in an all - comer population of patients with relapsed or refractory acute myeloid leukemia ( AML ) , including patients with NPM1 mutations and KMT2A rearrangements . In order to better inform an optimal Phase 2 dose , Kura has amended its KOMET - 001 trial of KO - 539 to include two Phase 1b expansion cohorts . Both cohorts will be enriched with NPM1 - mutant and KMT2A - rearranged relapsed / refractory AML patients . The Company expects to enroll at least 12 patients in each of the Phase 1b expansion cohorts and assess those patients for safety and tolerability , pharmacokinetics / pharmacodynamics and efficacy in order to determine the recommended Phase 2 dose . In addition , the amended Phase 1b protocol gives the Company flexibility to enroll up to 18 additional patients per cohort , as appropriate . Kura believes the patients enrolled in the cohort selected as the recommended Phase 2 dose have the potential to be included in the subsequent , registration - directed portion of the KOMET - 001 trial . Patient enrollment in the genetically enriched Phase 1b expansion cohorts is expected to begin at existing and new clinical sites in mid - 2021 . • Multiple expansion opportunities in acute leukemias - Pending determination of an optimal Phase 2 dose , kura is preparing to conduct a comprehensive clinical development plan for KO - 539 , both as a monotherapy and in combination , aimed at broadening the opportunity in acute leukemias . Additional opportunities include front line combination studies , additional genetic subtypes , a pediatric development strategy and other indications , such as acute lymphocytic leukemia and myelodysplastic syndrome . • Publication of tipifarnib Phase 2 data in Journal of Clinical Oncology - Data from Kura's Phase 2 clinical trial ( RUN - HN ) of tipifarnib were recently published in the Journal of Clinical Oncology . These data formed the basis of the Breakthrough Therapy Designation granted by the U.S. Food and Drug Administration ( FDA ) earlier this year for the treatment of patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma ( HNSCC ) . Tipifarnib is currently being evaluated in an ongoing registration - directed clinical trial ( AIM - HN ) in this indication of high unmet need . • Breakthrough Device Designation for HRAS companion diagnostic - The FDA has granted Breakthrough Device