Kura Oncology Inc - KURA STOCK NEWS

Kura Oncology and Kyowa Kirin announced positive results from their KOMET-001 Phase 2 trial of ziftomenib, an oral menin inhibitor for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). The trial achieved its primary endpoint with statistical significance, showing promising benefit-risk profile.

The companies plan to submit a New Drug Application (NDA) to the FDA in Q2 2025. Additionally, they received positive FDA feedback for two Phase 3 trials (KOMET-017) evaluating ziftomenib in combination therapies for newly diagnosed AML patients:

• KOMET-017-IC trial: combining with intensive chemotherapy
• KOMET-017-NIC trial: combining with venetoclax/azacitidine

Both Phase 3 trials are expected to begin in H2 2025, with dual-primary endpoints supporting potential accelerated and full FDA approval.

Kura Oncology (NASDAQ: KURA) announced key leadership changes with Mollie Leoni, M.D. promoted to Chief Medical Officer and Francis Burrows, Ph.D. elevated to Chief Scientific Officer. Stephen Dale, M.D., stepped down as CMO on January 2, 2025, to address personal health issues.

Dr. Leoni, who joined Kura in 2020, has been instrumental in developing ziftomenib, a potential therapy for acute myeloid leukemia (AML). Dr. Burrows, with the company since 2014, has led pipeline innovation targeting various conditions including gastrointestinal stromal tumors, diabetes, clear cell renal cell carcinoma, and KRAS-mutated non-small cell lung cancer.

Under Dr. Dale's leadership, the company successfully managed Project Optimus, advanced ziftomenib through its first registration-enabling study, and established foundations for KO-2806 as a combination treatment for multiple solid tumor indications.

Kura Oncology and Kyowa Kirin announced positive interim data from the Phase 1a portion of KOMET-007 trial, evaluating ziftomenib in combination with standard treatments for acute myeloid leukemia (AML). The study showed impressive results with a 100% complete remission rate in NPM1-m and 83% in KMT2A-r first-line adverse risk AML patients when combined with 7+3 therapy.

Key highlights include 100% survival rate in first-line NPM1-m and 96% in KMT2A-r AML patients, with median follow-up of 31 and 19 weeks respectively. The drug demonstrated promising activity in relapsed/refractory cases with venetoclax/azacitidine combination. Ziftomenib was well-tolerated across all dose levels, with manageable side effects.

Based on these positive results, the companies plan to initiate KOMET-017, a global Phase 3 study, in mid-2025.

Kura Oncology (NASDAQ: KURA) has announced a virtual investor event scheduled for December 9, 2024, at 8:00 a.m. ET / 5:00 a.m. PT. The event will discuss updated clinical data from the KOMET-007 combination trial of ziftomenib, their oral and selective menin inhibitor, following its presentation at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego.

The event will feature management team members and KOMET-007 trial investigators. Participants can join via phone (domestic: 800-715-9871, international: 646-307-1963, conference ID: 4326549) or through a live webcast available on Kura's website.

Kura Oncology (NASDAQ: KURA) announced its upcoming participation in the JMP Securities Hematology and Oncology Summit. Troy Wilson, President and Chief Executive Officer, will participate in a virtual fireside chat on December 2, 2024, at 2:00 p.m. ET / 11:00 a.m. PT. The event will be accessible via live audio webcast through the Investors section of Kura's website, with a replay available after the event.

Kura Oncology and Kyowa Kirin have announced a global strategic collaboration for developing and commercializing ziftomenib, a selective oral menin inhibitor for acute leukemias. The deal includes a $330 million upfront payment to Kura and potential milestone payments totaling $1.2 billion. The companies will share 50/50 profits in the U.S., with Kura leading U.S. operations and Kyowa Kirin having exclusive rights outside the U.S. The collaboration aims to advance ziftomenib through various development stages, including frontline indications and combinations. Kura expects to submit a New Drug Application in 2025 and initiate Phase 3 frontline studies in AML patients.

Kura Oncology and Kyowa Kirin have announced a global strategic collaboration for developing and commercializing ziftomenib, a selective oral menin inhibitor for acute myeloid leukemia (AML) treatment. Kura will receive a $330 million upfront payment and up to $1.2 billion in milestone payments. The companies will share 50/50 profits in the U.S., with Kura leading U.S. operations and Kyowa Kirin having exclusive rights outside the U.S. The collaboration includes development for frontline indications and combination therapies. Kura expects to submit a New Drug Application in 2025 and estimates a U.S. market opportunity of up to $3 billion annually in the frontline setting.

Kura Oncology has released its Q3 2024 financial results and corporate updates. Key highlights include the expected topline results from the registration-directed trial of ziftomenib in R/R NPM1-mutant AML in early 2025. Additionally, data from 100 patients in the Phase 1a study of ziftomenib will be presented at the ASH Annual Meeting. The Phase 1b expansion study of ziftomenib is now enrolling at 600 mg across all cohorts. Preclinical data supports the potential of ziftomenib in GIST, with a proof-of-concept study expected in 1H 2025. The first patient has been dosed in the study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC. Financially, Kura reported a net loss of $54.4 million for Q3 2024, compared to $38.6 million in Q3 2023. R&D expenses rose to $41.7 million from $29.3 million, and G&A expenses increased to $18.2 million from $13.1 million. The company holds $455.3 million in cash, cash equivalents, and investments, expected to fund operations into 2027.

Kura Oncology (KURA) announced two abstracts from the KOMET-007 combination trial of ziftomenib will be presented at the ASH Annual Meeting in San Diego (December 7-10, 2024). The trial combines ziftomenib with standard treatments in NPM1-mutant and KMT2A-rearranged acute myeloid leukemia (AML) patients.

Key highlights include: All four Phase 1a dose-escalation cohorts advanced to Phase 1b expansion at 600 mg; 100% of NPM1-m AML patients and 84% of KMT2A-r patients remained on study; No DLTs or ziftomenib-induced QTc prolongation reported. The data suggests promising safety profile and robust activity in combination with standard treatments.