Company Overview - Kura Oncology is preparing for the FDA approval of ziftomenib, with a PDUFA date set for November 30, indicating confidence in obtaining a competitive label for relapsed/refractory NPM1-mutant AML [3]. Product Development - The company has received positive feedback from key opinion leaders (KOLs) regarding the efficacy, simplicity, compatibility, and safety of ziftomenib compared to competitors [3]. - Kura's commercial team is fully established and ready for market access and preapproval information exchanges [3]. Future Prospects - Kura Oncology is also advancing ziftomenib in combination with standard treatments for frontline indications, indicating a strategic focus on expanding its therapeutic applications [4].

Core Insights - Ziftomenib is being evaluated in combination with approved FLT3 inhibitors for frontline treatment of acute myeloid leukemia (AML) [1][2] - FLT3 mutations are prevalent in approximately 30% of newly diagnosed adult AML patients and up to 50% in those with NPM1-mutated AML, highlighting the significance of FLT3 as a target [1] - The KOMET-007 clinical trial has commenced, focusing on ziftomenib's efficacy alongside cytarabine, daunorubicin, and quizartinib for newly diagnosed AML patients [1][2] Company Overview: Kura Oncology - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors [4] - Ziftomenib, a menin inhibitor, is under development to address specific genetic drivers of acute myeloid leukemias [4] Company Overview: Kyowa Kirin - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [5] - The company is committed to developing novel medicines and treatments for high unmet medical needs, including hematological diseases and rare diseases [5]

– Expanding clinical experience and safety profile of ziftomenib support its evaluation in combination with approved FLT3 inhibitors in frontline AML – – FLT3 mutations occur in approximately 30% of newly diagnosed adult patients with AML and up to 50% of adult patients with NPM1-m AML, making FLT3 one of the most common genetic alterations in AML – – Ziftomenib clinical trials are now active in multiple frontline settings that include up to 50% of incident patients with AML in the U.S. – SAN DIEGO and TOK ...

– KOMET-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated and full approval – – KOMET-017-NIC trial of venetoclax / azacitidine combination will assess CR and OS as dual-primary endpoints to support potential U.S. accelerated and full approval – SAN DIEGO and TOKYO, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that ...

Core Insights - Ziftomenib monotherapy demonstrated significant clinical benefit in treating relapsed/refractory NPM1-mutated acute myeloid leukemia (AML) with a complete remission rate of 22% [4][5] - The drug showed consistent activity across various patient subgroups, regardless of previous treatments or genetic mutations [4][5] - Ziftomenib has a favorable safety profile, with manageable adverse events and no significant drug-drug interactions [6][8] Company Overview - Kura Oncology is focused on developing precision medicines for cancer treatment, with ziftomenib being a key investigational drug targeting menin inhibition [10] - Kyowa Kirin is a global specialty pharmaceutical company committed to drug discovery and biotechnology innovation, collaborating with Kura Oncology on ziftomenib [11] Clinical Trial Results - The KOMET-001 trial included 92 adult patients, achieving an overall response rate of 33% and a median duration of response of 4.6 months [3][4] - Median overall survival for all patients was reported at 6.6 months, with responders showing a median survival of 18.4 months [5] - The trial's findings support the New Drug Application for ziftomenib, with a target FDA action date set for November 30, 2025 [7]

Core Insights - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [2] - The company is scheduled to participate in the UBS Virtual Oncology Day on October 1, 2025, at 2:30 p.m. ET [1] - A live audio webcast of the event will be available on Kura's website, with an archived replay following the event [1] Company Overview - Kura Oncology develops small molecule drug candidates targeting cancer signaling pathways, addressing high-need hematologic malignancies and solid tumors [2] - The company is advancing ziftomenib, a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemias [2] - Kura is also pioneering advancements in menin inhibition and farnesyl transferase inhibition to combat resistance mechanisms in solid tumors [2]

Core Insights - Kura Oncology is showcasing the potential of KO-2806 (darlifarnib) in combination with various targeted therapies to enhance anti-tumor activity and address resistance mechanisms in cancer treatment [1][2][4] Group 1: KO-2806 Development and Clinical Data - KO-2806 is a next-generation farnesyl transferase inhibitor (FTI) designed for superior potency and pharmacokinetics compared to first-generation candidates [4] - Preliminary clinical data for KO-2806 will be presented at the ESMO Congress 2025 in October [1][5] - The company is conducting ongoing Phase 1 trials for KO-2806, with a focus on its combination with standard-of-care agents [4] Group 2: Mechanisms of Action and Preclinical Findings - KO-2806 has shown robust preclinical activity by suppressing mTOR signaling, enhancing the efficacy of antiangiogenic TKIs, PI3Kα inhibitors, and KRAS inhibitors [4] - The preclinical studies indicate that KO-2806 can re-sensitize tumors in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) models to KRAS inhibitors [4] - The findings suggest broad applicability across multiple cancer types, potentially impacting over 200,000 new patients annually in the U.S. [4] Group 3: Future Events and Presentations - Kura plans a second analyst/investor event on October 18, 2025, to review clinical data from the ESMO Congress presentations [5] - The company emphasizes the importance of innovative combination therapies to overcome resistance in cancer treatment [2][4]

Core Insights - Kura Oncology, Inc. is hosting two virtual investor and analyst events to showcase its farnesyl transferase inhibitor (FTI) program, emphasizing its leadership in targeting cancer signaling pathways for solid tumors and hematologic malignancies [1][5] Event Summaries - The first event on September 16, 2025, will focus on the preclinical program of FTIs, discussing their synergistic combinations with targeted therapies such as tyrosine kinase inhibitors, RAS inhibitors, and PI3K alpha inhibitors, highlighting their potential to transform treatment for solid tumors [2] - The second event on October 18, 2025, will present clinical data from the 2025 ESMO Congress, including the first clinical insights from KO-2806, Kura's next-generation FTI, which aims to address resistance mechanisms in cancer [3] ESMO Congress Presentations - Kura will present preliminary results from the FIT-001 phase 1 trial of KO-2806 in combination with cabozantinib for renal cell carcinoma on October 18, 2025 [4] - A phase 1 study of KO-2806 as monotherapy in advanced solid tumors will be presented on October 19, 2025 [4] - Results from the KURRENT-HN trial involving tipifarnib and alpelisib in recurrent/metastatic head and neck squamous cell carcinoma will be shared on October 20, 2025 [4] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer, with a pipeline targeting cancer signaling pathways and addressing high-need hematologic malignancies and solid tumors [5] - The company is developing ziftomenib, a menin inhibitor for acute myeloid leukemias, and is advancing both menin and farnesyl transferase inhibition strategies to tackle resistance mechanisms in solid tumors [5][6]

Ziftomenib Development and Clinical Trials - Ziftomenib is a targeted menin inhibitor being developed for relapsed/refractory and newly diagnosed acute myeloid leukemia (AML)[7] - An NDA for ziftomenib has been granted Priority Review, with a PDUFA target action date of November 30, 2025[7] - Kura Oncology and Kyowa Kirin are collaborating to investigate ziftomenib across the AML continuum, targeting up to 50% of patients for whom the Menin-KMT2A pathway is a disease driver[59] - KOMET-017 are Phase 3 clinical trials evaluating ziftomenib in combination with intensive chemotherapy (7+3) or non-intensive therapy (Venetoclax + Azacitidine) in newly diagnosed AML patients[62] KOMET-007 Clinical Trial Results - In the KOMET-007 study, the combination of ziftomenib 600 mg QD with 7+3 chemotherapy showed a safety profile consistent with previous reports for newly diagnosed AML patients treated with 7+3 alone[56] - The KOMET-007 study demonstrated robust clinical activity in newly diagnosed NPM1-m and KMT2A-r AML patients, with a composite complete remission (CRc) rate of 93% for NPM1-m and 89% for KMT2A-r patients[56] - Composite complete remission with measurable residual disease (CRc MRD) negativity was achieved in 68% of NPM1-m patients at a median of 4.7 weeks and 83% of KMT2A-r patients at a median of 4.1 weeks[56] - 96% (47/49) of NPM1-m and 88% (29/33) of KMT2A-r patients remained alive and continued on-study, with median follow-up times of 25 and 16 weeks, respectively[56] AML Market and Opportunity - An estimated 22,000 new cases of AML are diagnosed each year in the United States[16] - Up to 50% of AML cases may be menin-dependent, including those driven by NPM1m and KMT2Ar mutations[19] - The potential peak sales for menin inhibitors in first-line AML is estimated to be greater than $7 billion per year in the U.S[73]

Core Insights - The KOMET-007 trial demonstrated encouraging clinical activity for ziftomenib in combination with 7+3 for newly diagnosed NPM1-m and KMT2A-r AML patients, showing high rates of complete remission and minimal residual disease negativity [1][2][4] Group 1: Clinical Data - In the KOMET-007 trial, 93% (41/44) of NPM1-m patients and 89% (24/27) of KMT2A-r patients achieved complete remission composite (CRc) [1] - Among responding patients, 71% (24/34) of NPM1-m and 88% (14/16) of KMT2A-r patients achieved measurable residual disease (MRD) negativity [1] - The median follow-up times were 24.9 weeks for NPM1-m patients and 15.7 weeks for KMT2A-r patients, with 96% (47/49) of NPM1-m and 88% (29/33) of KMT2A-r patients remaining alive [3] Group 2: Safety and Tolerability - The safety profile of ziftomenib was consistent with previous data, with Grade 3 adverse events occurring in over 10% of patients, including febrile neutropenia (15%) and decreased platelet count (15%) [4] - No dose-limiting toxicities or additive myelosuppression were observed, indicating a favorable safety profile for ziftomenib [4] Group 3: Future Developments - Kura Oncology plans to initiate the KOMET-017-IC and NIC Phase 3 studies in the second half of 2025 to further evaluate ziftomenib's efficacy in AML treatment [1][5] - A virtual investor event is scheduled for June 18, 2025, to discuss the results and broader development plans for ziftomenib [6] Group 4: Company Background - Kura Oncology is focused on developing precision medicines for cancer, with ziftomenib being the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for R/R NPM1-m AML [7] - Kyowa Kirin, a partner in the development of ziftomenib, has a long history in drug discovery and biotechnology innovation, aiming to address high unmet medical needs [9]