Earnings release
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KURA ONCOLOGY Kura Oncology Reports Third Quarter 2021 Financial Results November 4 , 2021 - Continued enrollment in Phase 1b study of menin inhibitor KO - 539 in NPM1 - mutant and KMT2A - rearranged relapsed / refractory AML - - ASH presentation to highlight molecular mechanisms of activity for KO - 539 and potential for synergistic activity in combination with venetoclax - - First clinical site activated in Phase 1/2 trial of tipifarnib plus alpelisib in HNSCC - - $ 543.4 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 , Nov. 04 , 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 third quarter 2021 financial results and provided a corporate update . " I am pleased by the progress our team has made over the past quarter , highlighted by accelerated enrollment in the Phase 1b expansion cohorts for KO - 539 , " said Troy Wilson , Ph.D. , J.D. , President and Chief Executive Officer of Kura Oncology . " We continue to be encouraged by preliminary results from the Phase 1b study , with evidence of activity at both doses and a favorable safety and tolerability profile . Pending determination of a recommended Phase 2 dose , we are designing a development strategy that builds on the potential to register KO - 539 as a monotherapy , while giving us the flexibility to get to larger opportunities in combination more quickly , including in earlier lines of therapy . We look forward to providing a more comprehensive update , including results from the Phase 1a and Phase 1b studies , at a future medical meeting . " Recent Highlights • Continued enrollment in Phase 1b expansion cohorts for KO - 539 - Kura is currently enrolling two expansion cohorts in the Phase 1b portion of its KOMET - 001 trial - a lower dose of 200 mg and a higher dose of 600 mg . Each cohort is comprised of patients with NPM1 - mutant or KMT2A - rearranged relapsed or refractory acute myeloid leukemia ( AML ) . Approximately half of an estimated 40 global sites are now actively screening patients for enrollment in the study . The Company maintains its enrollment guidance of 12 evaluable patients in each cohort by the first quarter of 2022. Once enrolled , patients in each cohort will be assessed for safety and tolerability , pharmacokinetics and efficacy to determine the recommended Phase 2 dose for KO - 539 . • Comprehensive clinical development strategy for KO - 539 – Pending determination of a recommended Phase 2 dose , Kura intends to conduct a comprehensive clinical development plan for KO - 539 , both as a monotherapy and in combination . This development strategy builds on the potential to register KO - 539 as a monotherapy while giving the Company the flexibility to address larger opportunities in combination more efficiently , including earlier lines of therapy . • ASH presentation to highlight potential for synergistic activity of KO - 539 with venetoclax - Encouraging pre - clinical data has been generated through a research collaboration with Dr. Kapil Bhalla at the MD Anderson Cancer Center highlighting the molecular mechanisms of anti - leukemic activity for KO - 539 and its potential for synergistic activity in combination with venetoclax in KMT2A - rearranged and NPM1 - mutant AML models . These data have been accepted for presentation at the upcoming American Society of Hematology ( ASH ) Annual Meeting in December 2021. The abstract was published earlier today and is now available on the ASH website . • Final results from Phase 2 study of tipifarnib in T - cell lymphoma at ASH – Final results from a Phase 2 study of tipifarnib in patients with relapsed or refractory peripheral T - cell lymphoma ( PTCL ) have been accepted for oral presentation by Dr. Thomas Witzig , Hematologist at Mayo Clinic and the study's lead investigator , at the upcoming ASH Annual Meeting . The abstract is now available on the ASH website . The clinical benefit demonstrated in patients with certain subtypes of T - cell lymphoma , including an overall response rate of 56.3 % ( 18/32 ) and a median overall survival of 32.8 months in patients with angioimmunoblastic T - cell lymphoma ( AITL ) , underscores the potential to target farnesyl transferase to drive clinical benefit in patients with cancer . • First clinical site activated in Phase 1/2 trial of tipifarnib plus 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 believes this combination has the potential to increase the