A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

Start Date30 Mar 2026

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT07255872

/ Not yet recruitingPhase 2/3

A Phase II/III Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M11D1 for Injection in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia

This study is an open, multicenter, dose-escalation and expansion, non-randomized phase II/III clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M11D1 in combination with cytarabine + daunorubicin or venetoclax + azacitidine in patients with newly diagnosed acute myeloid leukemia.

Start Date01 Dec 2025

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

NCT07052994

/ Not yet recruitingPhase 1IIT

A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients

The goal of Phase 1a of this clinical research study is to find the highest tolerable dose of revumenib that can be given in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin to patients who have acute leukemia.
The goal of Phase 1b of this clinical research study is to learn if the dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin found in Phase 1a can help to control the disease.

Start Date01 Dec 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

100 Clinical Results associated with Daunorubicin Hydrochloride

100 Translational Medicine associated with Daunorubicin Hydrochloride

100 Patents (Medical) associated with Daunorubicin Hydrochloride

11,143

Literatures (Medical) associated with Daunorubicin Hydrochloride

01 Jan 2026·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Dual-functional DNA nanoribbon-templated copper nanoclusters synergistically activate NRF2/HO-1 pathway for synergistic oxidative stress mitigation

Article

Author: Long, Qinghong ; Gao, Zhongfeng ; Mai, Xi ; Wang, Cheng ; Li, Xinyuan ; Liu, Shigang ; Li, Yingqi ; Li, Yanlei ; Xia, Fan ; Liu, Fanglan ; Sui, Xin ; Li, Na

Employing antioxidant nanozymes to eliminate reactive oxygen species (ROS) is a promising strategy for alleviating oxidative stress. However, most current nanozymes struggle to balance catalytic efficacy with biosafety, limiting their clinical applicability. In this study, we introduce a novel platform: DNA nanoribbon-templated copper nanoclusters (DNR/Cu NCs), which harness dual antioxidative mechanisms (direct ROS scavenging and activation of nuclear factor erythroid 2-related factor 2 (NRF2)/heme oxygenase-1 (HO-1) pathway) to synergistically mitigate oxidative stress. Unlike conventional nanozymes that rely on a single mechanism, DNR/Cu NCs exhibit combined superoxide dismutase (SOD)/catalase (CAT)/glutathione peroxidase (GPx), thereby enhancing overall ROS elimination. The biocompatible DNR scaffold facilitates the formation of ultrasmall Cu NCs with high catalytic activity and promotes NRF2 nuclear translocation to transcriptionally upregulate HO-1, amplifying endogenous antioxidant defenses. In both hepatocyte and zebrafish models of oxidative injury, the DNR/Cu NCs effectively suppressed ROS accumulation, suppressed apoptosis, and restored redox balance while mitigating tissue damage in vivo. This study highlights a paradigm-shifting approach in nanozyme design, offering a promising therapeutic avenue for oxidative stress-related diseases.

31 Dec 2025·DRUG DELIVERY

Biomaterial-based drug delivery: evaluating the safety profiles of liposomal Vyxeos

Article

Author: Liu, Zhicheng ; Fu, Zhuo ; Liu, Yahui ; Jiao, Yan

Vyxeos, a liposomal combination of cytarabine and daunorubicin, has improved survival outcomes for patients with high-risk acute myeloid leukemia (AML). However, its safety profile in real-world settings requires comprehensive evaluation. This study aims to assess the adverse event profiles associated with Vyxeos using data from the U.S. FDA's Adverse Event Reporting System (FAERS). A retrospective analysis of adverse event reports from the FAERS database was conducted for Vyxeos from January 2017 to June 2024. Reports were analyzed to assess patient demographics, system organ classes (SOCs), and preferred terms (PTs). Signal detection analysis was performed using disproportionality metrics, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). A total of 1,036 reports were analyzed. The most frequently reported adverse events were hematologic (37.73%), infectious (28.42%), and cardiac disorders (13.22%). Febrile neutropenia, neutropenic sepsis, and pneumonia fungal were the most commonly reported events, with febrile neutropenia showing a strong association (ROR = 92.18). Males had a higher frequency of infectious events, while females reported more cardiac events. Most adverse events occurred within 30 days of treatment initiation, and 16.92% of reports involved hospitalization, while 18.33% reported death. Vyxeos is associated with significant hematologic, infectious, and cardiac adverse events. Close monitoring, infection prophylaxis, and cardiac assessments are recommended for patients receiving Vyxeos. Further research is needed to validate these findings and explore the mechanisms underlying the observed toxicities.

31 Dec 2025·OncoImmunology

Potent immune-dependent anticancer effects of the non-cardiotoxic anthracycline aclarubicin

Review

Author: Sauvat, Allan ; Cerrato, Giulia ; Abdellatif, Mahmoud ; Kroemer, Guido

Aclarubicin (also called aclacinomycin A) is an antineoplastic from the anthracycline class that is used in China and Japan but not in Europe nor in the USA. Aclarubicin induces much less DNA damage than the classical anthracyclines doxorubicin, daunorubicin, epirubicin, idarubicin, and the anthracene mitoxantrone, but is equally effective in inhibiting DNA-to-RNA transcription and in eliciting immunogenic stress in malignant cells. Accordingly, aclarubicin lacks the DNA damage-associated cardiotoxicity that is dose-limiting for classical anthracyclines. Conversely, aclarubicin is at least as potent as other anthracyclines in inducing immunogenic cell death (ICD), which is key for the mode of action of efficient chemotherapeutics. This combination of reduced toxicity and equivalent ICD-stimulatory activity may explain why, as compared to other anthracyclines, aclarubicin is particularly efficient against acute myeloid leukemia. As a result, we advocate for clinical studies seeking to replace the anthracyclines used in Western medicine by aclarubicin-like compounds. Such clinical studies should not only embrace hematological malignancies but should also concern solid cancers, including those in which ICD-inducing chemotherapies are followed by immunotherapies targeting the PD-1/PD-L1 interaction.

News (Medical) associated with Daunorubicin Hydrochloride

04 Nov 2025

·ir.kuraoncology.com

Kura Oncology Reports Third Quarter 2025 Financial Results

– New Drug Application for ziftomenib in adults with R/R NPM1-m AML remains under FDA Priority Review, with a PDUFA target action date of November 30, 2025 – – KOMET 017 Phase 3 trials to evaluate ziftomenib in combination with intensive and non-intensive chemotherapy in frontline AML are accelerating; ziftomenib being investigated in settings representing more than 50% of AML patients – – Two oral presentations at 2025 ASH Annual Meeting on ziftomenib in combination with venetoclax / azacitidine chemotherapy in frontline and R/R NPM1-m AML – – Clinical data at ESMO 2025 Congress highlight promise of second strategic program – FTIs darlifarnib and tipifarnib show promising safety profile and clinical activity with targeted therapies in solid tumors – – $609.7 million in pro forma cash, together with anticipated collaboration payments, expected to support ziftomenib AML program through topline results in KOMET-017 – – Management to host webcast and conference call today at 8:00 a.m. ET – SAN DIEGO , Nov. 04, 2025 (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 2025 financial results and provided a corporate update. “Our momentum is accelerating across the ziftomenib program and our broader precision oncology pipeline,” said Troy Wilson , Ph.D., J.D., President and Chief Executive Officer. “With the initiation of the pivotal KOMET-017 Phase 3 trials, we are executing a robust, focused development strategy to unlock ziftomenib’s best-in-class potential across the continuum of unmet need in AML. Bolstered by a strong balance sheet and our productive partnership with Kyowa Kirin, we are well positioned to advance ziftomenib toward commercialization, accelerate our frontline Phase 3 trials and create enduring value across our pipeline for patients and other key stakeholders.” Recent Highlights In September 2025 , we announced the first patient was dosed in the Phase 3 KOMET-017 trial of ziftomenib in frontline AML (NCT07007312). KOMET-017 comprises two global, randomized, double-blind, placebo-controlled trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-m or KMT2A-rearranged (KMT2A-r) AML. In October 2025 , we announced the first patient was dosed in the FLT3 inhibitor cohort of the KOMET-007 clinical trial (NCT05735184). The cohort evaluates ziftomenib combined with the FDA-approved FLT3 inhibitor, quizartinib, plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD / NPM1 co-mutations. In September 2025 , the Journal of Clinical Oncolog y published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib as a monotherapy in adult patients with R/R NPM1-m AML. (Reprint) Two abstracts featuring clinical data from ziftomenib in combination with venetoclax / azacitidine (ven/aza) chemotherapy in patients with newly diagnosed and R/R NPM1-m or KMT2A-r AML were accepted for oral presentation at the 67th Annual Meeting of the American Society of Hematology (ASH) to be held in December 2025 . (Abstract ID 764; Abstract ID 766) In October 2025 , preliminary clinical data were presented at ESMO 2025, highlighting the potential of Kura’s farnesyl transferase inhibitors, darlifarnib (KO-2806) and tipifarnib, to enhance the anti-tumor activity of PI3Ka inhibitors, KRAS inhibitors and antiangiogenic tyrosine kinase inhibitors across a range of diverse tumor types by addressing a common resistance pathway. Data from the FIT-001 Phase 1 trial evaluating darlifarnib and cabozantinib in patients with renal cell carcinoma (RCC) reflect a manageable safety profile across multiple dose levels of each agent, including at the full label dose of cabozantinib. Antitumor activity was observed across all dose combinations tested, including in patients with prior exposure to cabozantinib. The objective response rate (ORR) was 33-50% in ccRCC, and 17-50% in patients with prior cabozantinib exposure. (Poster) Data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in patients with PIK3CA-dependent HNSCC also reflect a manageable safety profile. An ORR of 47% was observed at a dose of tipifarnib 1200 mg/day and alpelisib 250 mg/day. Robust antitumor activity was observed in a heavily pretreated patient population where clinical benefit is not expected from either alpelisib or tipifarnib as monotherapy. (Poster) In October and November 2025 , Kura received two $30 million milestone payments under its agreement with Kyowa Kirin in connection with first patient dosing in the pivotal KOMET-017 clinical trial of ziftomenib with intensive and non-intensive chemotherapy in patients with frontline AML. Data from the FIT-001 Phase 1 trial evaluating darlifarnib and cabozantinib in patients with renal cell carcinoma (RCC) reflect a manageable safety profile across multiple dose levels of each agent, including at the full label dose of cabozantinib. Antitumor activity was observed across all dose combinations tested, including in patients with prior exposure to cabozantinib. The objective response rate (ORR) was 33-50% in ccRCC, and 17-50% in patients with prior cabozantinib exposure. (Poster) Data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in patients with PIK3CA-dependent HNSCC also reflect a manageable safety profile. An ORR of 47% was observed at a dose of tipifarnib 1200 mg/day and alpelisib 250 mg/day. Robust antitumor activity was observed in a heavily pretreated patient population where clinical benefit is not expected from either alpelisib or tipifarnib as monotherapy. (Poster) Forecasted Milestones Continued regulatory interactions with the FDA ahead of the November 30, 2025 PDUFA target action date for ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1-m AML. Present preliminary clinical data in newly diagnosed NPM1-m AML and updated clinical data in R/R NPM1-m and KMT2A-r AML from KOMET-007 cohorts evaluating ziftomenib in combination with ven/aza at ASH Annual Meeting to be held in December 2025 . Present preliminary data from the KOMET-008 cohort evaluating ziftomenib in combination with the FLT3 inhibitor gilteritinib in patients with R/R NPM1-m AML in 2026. Initiate FIT-001 Phase 1b expansion cohorts of darlifarnib and cabozantinib in patients with advanced RCC in the first half of 2026. Present updated dose-escalation data from the combination of darlifarnib and cabozantinib in patients with advanced RCC in 2026. Present preliminary clinical data from the combination of darlifarnib and adagrasib in patients with KRASG12C-mutated solid tumor indications in 2026. Financial Results Collaboration revenue from our Kyowa Kirin partnership for the third quarter of 2025 was $20.8 million , compared to no revenue for the third quarter of 2024. Research and development expenses for the third quarter of 2025 were $67.9 million , compared to $41.7 million for the third quarter of 2024. General and administrative expenses for the third quarter of 2025 were $32.8 million , compared to $18.2 million for the third quarter of 2024. Net loss for the third quarter of 2025 was $74.1 million , compared to a net loss of $54.4 million for the third quarter of 2024. Net loss for the third quarter included non-cash share-based compensation expense of $11.0 million , compared to $8.3 million for the same period in 2024. As adjusted for the two $30 million clinical trial milestone payments earned under our collaboration agreement with Kyowa Kirin, Kura had, on a pro forma basis, cash, cash equivalents and short-term investments of $609.7 million as of September 30, 2025 . Based on our current plans, we believe that our cash, cash equivalents and short-term investments as of September 30, 2025 will be sufficient to enable us to fund our current operating expenses into 2027, and, combined with anticipated funding under our collaboration agreement with Kyowa Kirin, should support our ziftomenib AML program through topline results from KOMET-017. Conference Call and Webcast - Third Quarter 2025 Financial Results Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, November 4, 2025 , to discuss the financial results for the third quarter of 2025 and to provide a corporate update. A live webcast and archived replay of the event will be available here or online from the investor relations section of the Company’s website at www.kuraoncology.com. Conference Call and Webcast – ASH 2025 Annual Meeting Kura plans to host a virtual analyst and investor event at 12:30 p.m. ET / 9:30 a.m. PT on Monday, December 8, 2025 , to discuss the Company’s presentations from ziftomenib in combination with ven/aza chemotherapy in patients with newly diagnosed and R/R NPM1-m or KMT2A-r AML at the 67th Annual Meeting of the American Society of Hematology . A live webcast and archived replay of the event will be available online from the investor relations section of the Company’s website at www.kuraoncology.com. About Kura Oncology Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and it continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn. Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, ziftomenib’s best-in-class potential across the continuum of unmet need in AML; Kura’s ability to advance ziftomenib toward commercialization, accelerate our frontline Phase 3 trials and create enduring value for patients and other stakeholders; the potential duration of FDA’s review of the NDA; the potential FDA approval of product candidates; the success and impact of interactions with the FDA; continued regulatory interactions with the FDA; the efficacy, safety and therapeutic potential of Kura’s product candidates, ziftomenib, darlifarnib and tipifarnib; the expected timing of clinical trials; the expected timing and presentation of results and data from clinical trials; the strength of Kura’s balance sheet and the sufficiency of cash, cash equivalents and short-term investments to fund Kura’s current operating expenses into 2027 and, combined with anticipated funding under our collaboration agreement with Kyowa Kirin, to support Kura’s ziftomenib AML program through topline results from KOMET-017. Factors that may cause actual results to differ materially include risks associated with the commercialization of ziftomenib, the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risk that the collaboration with Kyowa Kirin is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. FLT3, Fms-like tyrosine kinase 3; HNSCC, head and neck squamous cell carcinoma; KMT2A, lysine methyltransferase 2A; NPM1, nucleophosmin 1; R/R, relapsed / refractory; ven/aza, venetoclax / azacitidine. Contacts Investors and media: Greg Mann 858-987-4046gmann@kuraoncology.com Source: Kura Oncology, Inc.

Phase 1Phase 3Financial StatementASHClinical Result

14 Oct 2025

·www.businesswire.com

Corventum Announces IND Clearance for CVT-130, a First-in-Class Small Molecule for the Prevention of Anthracycline Cardiotoxicity

BOSTON & SALT LAKE CITY--(BUSINESS WIRE)--Corventum, Inc., a new medicines company advancing novel therapies to make existing cancer treatments safer and more effective, today announced the clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for CVT-130 for the prevention of anthracycline-related cardiotoxicity. CVT-130 is a first-in-class metabolic modulator being developed to protect against chemotherapy-induced cardiac injury and to address additional diseases involving mitochondrial dysfunction. The company plans to initiate a first-in-human Phase 1 clinical trial in the second quarter of 2026. “Our preclinical data show that CVT-130 prevents cardiac injury while maintaining full anti-tumor potency, a balance that no therapy has achieved to date,” said Aarti Asnani, M.D., Corventum co-founder and Chair of the Cardio-Oncology Committee of the AHA. “Anthracyclines have saved countless lives, yet the use of these highly effective chemotherapies is limited by cumulative heart damage that can appear months or years after treatment,” said Randall Peterson, Ph.D., Corventum co-founder, CVT-130 co-inventor, and Dean of the University of Utah College of Pharmacy. “CVT-130 was designed to protect cardiac cells from damage caused by anthracyclines, potentially allowing more patients to benefit from these widely used cancer treatments and enabling retreatment in recurrent disease.” “Our preclinical data show that CVT-130 prevents cardiac injury while maintaining full anti-tumor potency, a balance that no therapy has achieved to date,” said Aarti Asnani, M.D., Corventum co-founder, CVT-130 co-inventor, and Chair of the Cardio-Oncology Committee of the American Heart Association. “With FDA clearance of the IND, we can now advance CVT-130 to the clinic and take the next step toward delivering a therapy that could benefit millions of patients worldwide who depend on anthracyclines for cancer treatment.” The planned randomized, placebo-controlled Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CVT-130 in healthy volunteers, along with cardiac and mitochondrial biomarkers. The study is designed to identify an optimal dose for a subsequent Phase 2 trial in cancer patients. Corventum worked closely with the FDA to align on the Phase 1 study design, which reflects the intended dosing strategy for the Phase 2 clinical trial. About Anthracycline Cardiotoxicity Anthracyclines, including doxorubicin, epirubicin, and daunorubicin, are among the most effective cancer drugs developed and are used in more than two million patients each year. Their clinical utility, however, is limited by cumulative, dose-dependent cardiac damage that can lead to heart failure and reduced long-term survival. Once patients reach their lifetime anthracycline dose limit, retreatment is often impossible, even if their cancer recurs, forcing reliance on less effective alternatives. About CVT-130 CVT-130 is a novel small molecule that has demonstrated robust preclinical cardioprotection with no loss of anthracycline efficacy. It is designed to modulate mitochondrial and metabolic pathways to prevent anthracycline-induced cardiac injury and preserve mitochondrial function. CVT-130’s room-temperature stable formulation allows rapid injection prior to anthracycline chemotherapy administration. About Corventum, Inc. Corventum is a new medicines company committed to developing novel therapies that make cancer treatments safer and more effective. The company's lead program, CVT-130, is designed to prevent anthracycline-induced cardiotoxicity and improve outcomes for patients receiving these cornerstone chemotherapies. For more information, visit www.corventum.com.

Phase 1Phase 2IND

01 Oct 2025

·ir.kuraoncology.com

Kura Oncology and Kyowa Kirin Launch Clinical Trial Evaluating Dual Inhibition of NPM1 and FLT3 Mutations in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

– 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 TOKYO , Oct. 01, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced dosing of the first patient in a cohort of the KOMET-007 clinical trial (NCT05735184). This cohort evaluates ziftomenib, a once-daily, investigational oral menin inhibitor, combined with cytarabine and daunorubicin (7+3) as well as quizartinib, for patients with newly diagnosed acute myeloid leukemia (AML). Despite recent advances, including regulatory approvals of FLT3 inhibitors such as quizartinib, patients with FLT3/NPM1 co-mutations face a high risk of relapse and limited durable treatment options. Ziftomenib is the only menin inhibitor to have received Breakthrough Therapy Designation by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory NPM1-mutated AML. “Patients with FLT3/NPM1 co-mutated AML, a significant subset of newly diagnosed cases, face high relapse rates and limited durable treatment options,” said Mollie Leoni , M.D., Chief Medical Officer of Kura Oncology . “Preclinical data demonstrate that ziftomenib synergizes with FLT3 inhibitors such as quizartinib, potentially enhancing activity without increasing toxicity. The KOMET-007 trial, alongside our recently launched KOMET-017 registrational trial combining ziftomenib with intensive and non-intensive chemotherapy, reflects our commitment to integrating menin inhibition across AML treatment regimens to improve patient outcomes.” “Initiation of the FLT3 inhibitor cohort in the KOMET-007 trial marks a pivotal advancement in addressing the urgent needs of patients with FLT3/NPM1 co-mutated AML,” said Takeyoshi Yamashita , Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. “FLT3 mutations play a critical role in AML, driving aggressive leukemia cell proliferation, leading to poor prognosis, higher relapse rates, and shorter overall survival. Kyowa Kirin is proud to collaborate with Kura Oncology to advance this innovative menin inhibitor combination, aiming to improve outcomes for AML patients throughout the continuum of care.” The trial arm will evaluate safety, tolerability and activity of intensive chemotherapy and quizartinib in combination with ziftomenib in adult patients with newly diagnosed FLT3-ITD / NPM1 co-mutated AML. Primary and secondary endpoints include complete remission (CR) and composite complete remission (CRc). More information regarding this trial arm and the KOMET-007 trial is available at www.clinicaltrials.gov (identifier: NCT05735184). Ziftomenib is currently under clinical development, and its safety and efficacy have not been established by any regulatory authority. About Kura Oncology Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and continues to pioneer advancements in both menin inhibition and farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn. About Kyowa KirinKyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan -based Global Specialty Pharmaceutical Company , Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology and rare diseases. A shared commitment to Kyowa Kirin’s values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com. Kura Forward-Looking StatementsThis news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the safety, tolerability, and therapeutic potential of ziftomenib, and expectations regarding trial enrollment. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, the risk that the collaboration with Kyowa Kirin is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Kura Contact Investors and Media: Greg Mann 858-987-4046gmann@kuraoncology.com Kyowa Kirin Contacts Investors: Ryohei Kawai ir@kyowakirin.com Media, Global: Nobuyuki Manita media@kyowakirin.com Source: Kura Oncology, Inc.

Clinical StudyBreakthrough Therapy

100 Deals associated with Daunorubicin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01264	Daunorubicin Hydrochloride	L01DB02	DBSALT000665

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
acute leukemia	South Korea	KOREA PHARMA Co., Ltd.	10 Feb 1998
Infectious Diseases	China	Shenzhen Main Luck Pharmaceuticals, Inc.	01 Jan 1994
Acute Lymphoblastic Leukemia	United States	Wyeth-Ayerst Research	19 Dec 1979
Acute Myeloid Leukemia	United States	Wyeth-Ayerst Research	19 Dec 1979
Leukemia	United States	Wyeth-Ayerst Research	19 Dec 1979

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	IND Approval	China	Qingyuan Pharmaceutical Peaks CR Ltd.	14 Mar 2025
NRAS Mutant Melanoma	Preclinical	Luxembourg	University of Luxembourg	01 Oct 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCRI AML18 (ASH2024)	Phase 2	Acute Myeloid Leukemia MDS-related gene mutations	506	CPX-351	yxedbzmunl(xituaigzuw) = efnrrdascd buweoyiewj (sqiwvqosnx, 0.57 - 0.93) View more	Negative	07 Dec 2024
				DAGO2	yxedbzmunl(xituaigzuw) = ugohausydg buweoyiewj (sqiwvqosnx, 0.73) View more
NCT03724084 (CTgov)	Phase 1/2	Acute Myeloid Leukemia \| Treatment related acute myeloid leukaemia \| Acute Promyelocytic Leukemia	6	Pinometostat+Cytarabine+Daunorubicin Hydrochloride (Cohort II (Higher Dose Pinometostat))	sgklkicrbx = sgnahdtjhc yhrwbjqmuk (hisxxdmtir, akbztiwddd - gbkqwvgbwn) View more	-	11 Jun 2024
				Pinometostat+Cytarabine+Daunorubicin Hydrochloride (Cohort I (Higher and Lowers Dose Pinometostat))	tgyxqtklie(cydtkwgive) = nqmyhyhtho volyoupkdm (zmvobypnqm, rcxjodtpqq - cfkorwctcv) View more
NCRI AML18 (ASH2023)	Not Applicable	Acute Myeloid Leukemia	523	DA	qehqnuxomf(aalqrjaquv): HR = 0.9 (95% CI, 0.7 - 1.16), P-Value = 0.407	-	11 Dec 2023
				FLAG-Ida
NOPHO-DBH AML2012 (ASH2023)	Phase 3	Acute Myeloid Leukemia	306	AD(x)E	scbzukcpsw(yjwkeaijyy) = csulkoaqww exsyxaykli (pmjwoauyml ) View more	-	11 Dec 2023
				FLAD(x)	scbzukcpsw(yjwkeaijyy) = uqkrewjrna exsyxaykli (pmjwoauyml ) View more
ASH2023	Not Applicable	FLT3 positive Acute Myeloid Leukemia	20	CPX-351	gegzwswjyy(pnltrmwihv) = One patient died from sepsis after hematopoietic stem cell transplant hobqkxtlty (xyfeannrhk )	-	10 Dec 2023
				CPX-351 + Gemtuzumab Ozogamicin
ASH2023	Not Applicable	Acute Myeloid Leukemia	24	Venetoclax plus '2 + 5' modified intensive chemotherapy with daunorubicin and cytarabine	vdgnqrkhba(lznzzexpmr) = 100% najaxerukm (vkujemrzpa ) View more	-	10 Dec 2023
ASH2023	Not Applicable	Adult Acute Myeloblastic Leukemia	25	Venetoclax	dzodrhyngt(jltvzpvmkv) = The most frequent hematological adverse events were Grade 3 to 4 anemia, thrombocytopenia, and neutropenia during the induction treatment and occurred in all patients (25/25 100%) nemgvfuvow (eymgqknhly ) View more	-	10 Dec 2023
NCT04562792 (CTgov)	Phase 2	Refractory acute myeloid leukemia \| Refractory Adult Acute Lymphoblastic Leukemia \| Recurrent Childhood Acute Lymphoblastic Leukemia	1	Daunorubicin	uianoyhdlg = omrqaasmhb ryqpjlbimv (bmlxzpobkm, dmriobjyzf - gwmjxkizmy) View more	-	06 May 2023
NCT01371981 (AAML1031, CTgov)	Phase 3	Acute Myeloid Leukemia \| Myeloid Tumor \| Cutaneous lymphoma ... View more	1,645	Quality-of-Life Assessment+Etoposide+Mitoxantrone Hydrochloride+Asparaginase+Cytarabine+Daunorubicin Hydrochloride (Arm A)	ihlcjmnijd = kywvuzxvvo wsoscxudqf (bquqagtwli, xolzbecmyd - ngguublkud) View more	-	07 Jul 2020
				Quality-of-Life Assessment+Etoposide+Mitoxantrone Hydrochloride+Asparaginase+Bortezomib+Cytarabine+Daunorubicin Hydrochloride (Arm B)	ihlcjmnijd = nfqqkcvofh wsoscxudqf (bquqagtwli, agzgnjqzae - nxgkfmbnrl) View more
DaunoDouble (EHA2020)	Not Applicable	Acute Myeloid Leukemia	-	Dauno90	ivqqabnsvy(aowbkwscze) = jdslmojeji fsdatoapzx (afuylxkjdy ) View more	Positive	14 May 2020
				Dauno60	ivqqabnsvy(aowbkwscze) = jlbcexceyc fsdatoapzx (afuylxkjdy ) View more

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