Ziftomenib

– 87% ORR and 70% CRc in venetoclax-naïve and 48% ORR and 24% CRc in venetoclax-experienced patients at the recommended 600 mg once-daily dose – – Central MRD negativity in 75% of CRc responders with no prior venetoclax exposure; median CRc duration was 9.2 months – – Median OS not reached after median follow up of 10.7 months in patients with no prior venetoclax exposure – – Combination was well tolerated, with low rates of differentiation syndrome and QTc prolongation observed – SAN DIEGO and TOKYO, June 02, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the publication in Blood of updated results from the relapsed/refractory (R/R) NPM1 -mutated acute myeloid leukemia ( NPM1 -m AML) cohort of KOMET-007, a Phase 1a/b trial evaluating ziftomenib in combination with venetoclax and azacitidine (ven/aza). The publication reports nearly two-thirds of patients experienced clinically meaningful, deep and durable responses with a well-tolerated safety pro adults with R/R NPM1 -m AML. KOMZIFTI™ (ziftomenib) is approved by the U.S. Food and Drug Administration as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM 1 mutation who have no satisfactory alternative treatment options. Ziftomenib in combination with ven/aza is investigational and has not been approved by the FDA. “This analysis provides a more mature evaluation of ziftomenib in combination with venetoclax and azacitidine in patients with NPM1 -mutated AML,” said Eunice S. Wang, M.D., Chief of Leukemia, Roswell Park Comprehensive Cancer Center, and co-first senior author of the publication. “In the relapsed/refractory setting, outcomes with venetoclax-based regimens in patients with NPM1 -mutant AML remain suboptimal, highlighting the substantial need for more effective therapies. These KOMET-007 results are notable for the depth and durability of response observed with the investigational three-drug combination. The favorable safety pro supports the continued evaluation of this combination in a setting where better treatment options are urgently needed.” “As combination approaches become increasingly important in this setting, the data highlighted in this publication strengthen the case for ziftomenib as a backbone in NPM1 -mutant AML,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “Ziftomenib combined with ven/aza demonstrated deep molecular responses, durable remissions, and a generally manageable safety pro R/R NPM1 -m AML. These findings support our ongoing efforts to evaluate ziftomenib-based combinations across the treatment continuum, including in randomized studies designed to define the potential of ziftomenib in newly diagnosed disease.” KOMET-007 Results in R/R NPM1 -m AML The data include 64 response-evaluable patients with R/R NPM1 -m AML from the ongoing KOMET-007 Phase 1a/b trial ( NCT05735184 ), 27 of whom were treated in phase 1a dose escalation and 37 of whom were treated in phase 1b expansion, as of the January 16, 2026 data cutoff date. Patients had received 1 to 8 prior lines of therapy (median of 1), and 37 patients (55%) had prior venetoclax exposure. Robust clinical activity was observed in patients with R/R NPM1 -m AML across all ziftomenib dose levels, with nearly two-thirds of all patients experiencing clinically meaningful, deep, and durable responses. In addition, rapid responses were observed, with a median time to composite complete remission (CRc) of 3.9 weeks. Venetoclax-Naïve Population (600 mg ziftomenib) 70% CRc rate (16/23) with 75% (9/12) central measurable residual disease (MRD) negativity ( 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death. Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose. ADVERSE REACTIONS Fatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI, including 2 with differentiation syndrome, 1 with infection, and 1 with sudden death. Serious adverse reactions were reported in 79% of patients who received KOMZIFTI. Serious adverse reactions occurring in ≥ 5% of patients included infection without an identified pathogen (29%), febrile neutropenia (18%), bacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%). Dosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of patients. Adverse reactions that required dose interruption in ≥ 2% of patients included infection without an identified pathogen (15%), differentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%), electrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection (3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%), and thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction occurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an adverse reaction occurred in 21% of patients. Adverse reactions that required permanent discontinuation of KOMZIFTI in ≥ 2% of patients were infection without an identified pathogen (8%), bacterial infection (4%), cardiac arrest (2%), and differentiation syndrome (2%). Most common (≥ 20%) adverse reactions, including laboratory abnormalities , were aspartate aminotransferase increased (53%), infection without an identified pathogen (52%), potassium decreased (52%), albumin decreased (51%), alanine aminotransferase increased (50%), sodium decreased (49%), creatinine increased (45%), alkaline phosphatase increased (41%), hemorrhage (38%), diarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection (28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium increased (26%), differentiation syndrome (26%), pruritus (23%), febrile neutropenia (22%), and transaminases increased (21%). DRUG INTERACTIONS Drug interactions may occur when KOMZIFTI is concomitantly used with: Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for KOMZIFTI-associated adverse reactions. Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI. Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting antacids. If concomitant use with H2RAs or locally acting antacids cannot be avoided, modify KOMZIFTI administration time. Take KOMZIFTI 2 hours before or 10 hours after administration of an H2 receptor antagonist. Take KOMZIFTI 2 hours before or 2 hours after administration of a locally acting antacid. Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms. USE IN SPECIFIC POPULATIONS Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI. Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose. Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential. Please see full Prescribing Information , including Boxed WARNING . 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, among other things, statements regarding the potential of ziftomenib to serve as a combination backbone in NPM1 -mutant AML. 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 . 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 Contacts Investors and Media: Greg Mann 858-987-4046 gmann@kuraoncology.com Kyowa Kirin Contacts Investors: Ryohei Kawai ir@kyowakirin.com Media, Global: Sachiko Kido media@kyowakirin.com

iStock, Deagreez Nearly 80% of patients saw tumor shrinkage after being treated with Kura Oncology’s darlifarnib plus Bristol Myers Squibb’s Krazati, findings Mizuho analysts say could open up a $2 billion opportunity for the biotech. An experimental regimen combining Kura Oncology’s darlifarnib with Bristol Myers Squibb’s Krazati shrunk tumors in patients with KRAS-mutated tumors, unlocking what Mizuho Securities anticipates to be a $2-billion market opportunity. In the first-in-human FIT-001 trial, the investigational combo showed an objective response rate of 67% in patients with pancreatic cancer, 50% in non-small cell lung cancer and 29% in colorectal cancer, according to a Tuesday news release . Overall, 77% of the 26 patients saw tumor shrinkage after receiving darlifarnib plus Krazati, including 94% of the 16 patients who had not been treated with a KRAS inhibitor before. Mizuho called these findings “encouraging” while emphasizing that “the data are early yet.” Still, the analysts noted that, at least on a historical basis, darlifarnib plus Krazati either matches or outperforms Krazati monotherapy in a clutch of indications, including colorectal, lung and pancreatic cancer—particularly in heavily pretreated patients. “We currently model unadjusted ~$2Bn peak sales for darlifarnib,” the firm continued, “across multiple combinations and tumor types.” For Kura, darlifarnib presents a “significant potential opportunity” outside of its main product Komzifti, a menin inhibitor approved for relapsed or refractory acute myeloid leukemia. Darlifarnib is a next-generation blocker of the farnesyltransferase enzyme, a mechanism of action that, according to the biotech’s website , could “unlock multiple targeted treatment paths for a range of difficult cancers.” Farnesyltransferase is involved in cellular cascades that could drive resistance to cancer therapies, Kura explained, and darlifarnib’s activity could counteract drug resistance and boost the efficacy of existing cancer therapies. FIT-001’s study population is reflective of this mechanism: 43% of patients had already undergone at least three previous lines of systemic treatment, while 40% had been exposed to KRAS inhibition before. Darlifarnib’s efficacy in this particular study sample suggests “activity in patients that had previously failed” prior KRAS inhibitor treatments, Mizuho said. “With compelling clinical activity across multiple tumor types and a manageable safety profile, darlifarnib is well-positioned as a preferred combination partner for KRAS inhibitors and other precision therapies,” Kura CEO Troy Wilson said in a prepared statement on Tuesday. The biotech has yet to provide a specific timeline for when it plans to push darlifarnib into more advanced development.