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KURA ONCOLOGY Kura Oncology Reports Second Quarter 2021 Financial Results August 5 , 2021 - First patients dosed in Phase 1b expansion cohorts with menin inhibitor KO - 539- - Clinical collaboration with Novartis to evaluate tipifarnib in combination with the PI3Ka inhibitor alpelisib in HNSCC - -KO - 2806 nominated as lead development candidate in next - generation farnesyl transferase inhibitor program - - $ 567.5 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 , Aug. 05 , 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 second quarter 2021 financial results and provided a corporate update . " I am extremely proud of the progress our team has made over the past several months , underscoring our focus on operational execution , " said Troy Wilson , Ph.D. , J.D. , President and Chief Executive Officer of Kura Oncology . " We continue to have strong conviction in KO - 539 and its potential to be both a first - in - class and a best - in - class menin inhibitor . This confidence is supported by clinical data from KOMET - 001 , our Phase 1/2 trial of KO - 539 in patients with relapsed or refractory acute myeloid leukemia ( AML ) . Given the wide therapeutic window KO - 539 demonstrated in the Phase 1a dose escalation portion of the trial , we have now advanced into the Phase 1b expansion cohorts in patients with NPM1 - mutant and KMT2A - rearranged relapsed / refractory AML . The Phase 1b enables us to refine the selection of a recommended Phase 2 dose while maintaining an aggressive development timeline for the program . " " Although it is early and the results are still preliminary , " continued Dr. Wilson , " we are encouraged by observations of early signs of clinical activity in the Phase 1b expansion cohorts . We are also encouraged by the rate of patient screening and enrollment , an indication of the enthusiasm of the investigators as well as the strong execution of our clinical operations team . We intend to provide an update on both the Phase 1a and the Phase 1b at a future medical meeting , pending determination of the recommended Phase 2 dose . In the meantime , we look forward to providing qualitative updates on the progress of the Phase 1b in the months ahead . " Recent Highlights • First patients dosed in Phase 1b expansion cohorts with KO - 539 - In late June , Kura announced that the first patient was dosed in the Phase 1b portion of KOMET - 001 . Patients are now enrolled in each of the two expansion cohorts - a lower dose of 200 mg and a higher dose of 600 mg - each comprising NPM1 - mutant and KMT2A - rearranged relapsed / refractory AML patients . The Company expects to complete enrollment of 12 evaluable patients in each cohort by the first quarter of 2022 , then will assess those patients for safety and tolerability , pharmacokinetics and efficacy in order to determine the recommended Phase 2 dose . • Multiple expansion opportunities in acute leukemias - Pending determination of a recommended Phase 2 dose , Kura is preparing to conduct a comprehensive clinical development plan for KO - 539 , aimed at broadening the opportunity in acute leukemias . Additional development opportunities include combination studies , other genetic subtypes , a pediatric development strategy and other indications , such as acute lymphocytic leukemia and myelodysplastic syndrome . • Clinical collaboration to evaluate tipifarnib and alpelisib in HNSCC - In July , Kura announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and the PI3Ka inhibitor alpelisib in patients with head and neck squamous cell carcinoma ( HNSCC ) . The Company is now preparing for a Phase 1/2 clinical trial ( KURRENT ) of tipifarnib in combination with alpelisib in patients who have HRAS- and / or PIK3CA - dependent HNSCC . The initial cohort will include patients who have PIK3CA - dependent HNSCC and the trial is expected to initiate in the fourth quarter of 2021 . • Nomination of KO - 2806 as lead development candidate - Kura has nominated KO - 2806 as its lead development candidate in the Company's next - generation farnesyl transferase inhibitor program . KO - 2806 was nominated based on its improved potency , pharmacokinetic and physicochemical properties relative to tipifarnib , and is designed to target innovative biology and address large oncology indications of high unmet need through rational combinations . The Company is now conducting investigational new drug ( IND ) -enabling studies and expects to submit an IND application for KO - 2806 by the end of 2022 . • Addition of industry veterans to board of directors - Kura recently appointed Carol Schafer and Helen Collins , M.D. to