Latest news with #KURA
Business Insider
03-06-2025
- Business
- Business Insider
Kura Oncology says ‘positive' results from KOMET-001 Phase 2 trial of ziftomenib
Kura Oncology (KURA) announced the presentation of positive pivotal results from the KOMET-001 Phase 2 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting being held in Chicago, IL from May 30 – June 3, 2025. 'We are delighted to announce positive pivotal data from the KOMET-001 trial in R/R NPM1-mutated AML patients treated with ziftomenib,' said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. 'NPM1 mutations are among the most common in AML, representing approximately 30% of cases, and there are no FDA-approved therapies specifically for this patient population. With these encouraging results and a PDUFA target action date of November 30, 2025, we and our partners at Kyowa Kirin look forward to supporting FDA with its review of the ziftomenib New Drug Application and are well-positioned to meaningfully impact relapsed or refractory patients with NPM1 mutations.' The KOMET-001 Phase 2 population included 92 adult patients with R/R NPM1-m AML. The median age was 69. Patients were heavily pretreated, with 33% having received three or more prior lines of therapy (median prior lines: 2) and 59% having been previously treated with venetoclax. A complete remission plus CR with partial hematological recovery rate of 23% was observed among patients with R/R NPM1-m AML in the Phase 2 portion of the KOMET-001 trial. Among those 21 patients who achieved CR/CRh, 13 had a CR and 8 had a CRh. The median duration of CR/CRh responses was 3.7 months and the restricted mean duration of response was 4.3 months at the time of the data cutoff. MRD status was assessed in 19 of 21 patients who achieved CR/CRh, and 63% of these patients were MRD-negative. Comparable CR/CRh rates were observed across pre-specified subgroups, regardless of prior HSCT, prior venetoclax or FLT3/IDH co-mutations. Additional patient benefit beyond CR/CRh was observed with a rate of transfusion conversion of 21% and a rate of maintenance of transfusion independence of 20%. A median OS of 16.4 months was observed for responders and a median overall survival of 3.5 months was observed among non-responders. The safety population included 112 adult patients with R/R NPM1-m AML from the pooled Phase 1b and Phase 2 portions of the KOMET-001 trial. The safety profile observed with ziftomenib in this population was consistent with previously reported data. Treatment-related adverse events led to treatment discontinuations in 3% of patients. TRAEs of Grade greater than or equal to3 which occurred in more than 10% of patients were limited to differentiation syndrome, which was well managed by protocol-specified mitigation strategies and no Grade 4/5 treatment-related DS was observed. Although QTc prolongation was reported in three patients per investigator assessment, all three patients were on concomitant medications associated with QTc prolongation, two had electrolyte abnormalities and one had a prior diagnosis of atrial fibrillation.
Metropolis Japan
29-05-2025
- Entertainment
- Metropolis Japan
"Shape Of Light" Art Exhibition
UltraSuperNew will present an exhibition titled 'Shape of Light | 光の姿' by contemporary abstract artist Lin Syouki, originally from China, at its alternative space KURA. This eighth installment at KURA will showcase Lin's works centered around the theme of a 'dialogue of light' between the viewer and the artwork, exploring the fragility of perception and existence. Influenced by the theory of spatialism, Lin Syouki has long focused on the interplay of perception, light, and space. Born in China and based in Tokyo since 2018, she merges geometric forms such as circles and squares with spontaneous abstract expression. Her latest works incorporate retroreflective materials, originally studied in 19th-century optical research and now commonly used in sportswear. These materials cause the artworks to shift in appearance based on the viewer's angle and lighting, creating a continuously evolving visual experience. Exhibition Schedule: Opening Reception: May 30, 6pm–9pm Exhibition Period: May 31 – June 14 Open Hours: 2pm – 7pm Saturdays: 11am – 7pm Closed: Sundays and Mondays UltraSuperNew KURA 2-6-18 Higashi, Shibuya-ku
Yahoo
02-05-2025
- Business
- Yahoo
Kura Oncology Inc (KURA) Q1 2025 Earnings Call Highlights: Strategic Advances Amid Rising Costs
Collaboration Revenue: $14.1 million for Q1 2025, compared to no revenue in Q1 2024. Research and Development Expenses: $56 million for Q1 2025, up from $36.3 million in Q1 2024. General and Administrative Expenses: $22.8 million for Q1 2025, compared to $18.2 million in Q1 2024. Net Loss: $57.4 million for Q1 2025, compared to $49.5 million in Q1 2024. Cash, Cash Equivalents, and Short-term Investments: $658.2 million as of March 31, 2025, compared to $727.4 million as of December 31, 2024. Pro Forma Cash Position: $703.2 million as of March 31, 2025, adjusted for a $45 million milestone payment. Warning! GuruFocus has detected 3 Warning Signs with KURA. Release Date: May 01, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Kura Oncology Inc (NASDAQ:KURA) has submitted a New Drug Application (NDA) for ziftomenib, a menin inhibitor, for the treatment of relapsed or refractory NPM1-mutant acute myeloid leukemia (AML), marking a significant regulatory milestone. The company has achieved a $45 million milestone payment from its collaboration with Kyowa Kirin, enhancing its financial position. Kura Oncology Inc (NASDAQ:KURA) has a strong cash position with $703.2 million in cash, cash equivalents, and short-term investments, providing sufficient capital to fund its ziftomenib AML program through commercialization. The company is advancing its FTI program, with plans to share preliminary clinical data from multiple Phase 1 cohorts later this year, indicating potential for FTIs as combination therapies. Kura Oncology Inc (NASDAQ:KURA) has announced the appointment of Samir Vattompadam as Senior Vice President, Global Program Leadership, bringing over 20 years of experience in the biotech and pharmaceutical industry to the team. Research and development expenses increased to $56 million in Q1 2025 from $36.3 million in Q1 2024, indicating rising costs. The company reported a net loss of $57.4 million for Q1 2025, compared to a net loss of $49.5 million in Q1 2024, reflecting ongoing financial challenges. General and administrative expenses rose to $22.8 million in Q1 2025 from $18.2 million in the same period in 2024, suggesting increased operational costs. Despite progress, the competitive landscape for menin inhibitors in the relapsed/refractory AML setting remains challenging, with other companies also advancing in this space. The company faces potential uncertainties in the regulatory approval process, although it has not experienced any disruptions or delays so far. Q: Can you set expectations for the combo data coming later this year, especially the aza/ven cohort? What do you need to show to be competitive? A: We are primarily focused on safety in these preliminary data presentations. We want to establish the ability to safely combine ziftomenib with venetoclax in the frontline. We aim to demonstrate the combinability of ziftomenib without added toxicity or adverse events. We remain on track to start the study in the second half of 2025. - Mollie Leoni, Chief Medical Officer Q: How have changes at the regulatory agency impacted the potential approval process and timelines for ziftomenib? A: We have not seen any impact from changes at the FDA. The agency has been responsive and collaborative. We requested priority review and expect to receive notification on the application acceptance and PDUFA date in the second quarter. - Troy Wilson, CEO Q: What is your strategy for capturing market share in the NPM1 setting, given the competitive landscape? A: We emphasize safety, tolerability, and clinical activity. We believe ziftomenib will be competitive in the relapsed/refractory setting. We are working with Kyowa Kirin to bring resources and focus to compete for every patient, aiming for use in earlier lines of therapy and in combination. - Troy Wilson, CEO and Brian Powl, Chief Commercial Officer Q: How do you envision the long-term development of KO-2806 in combination with VEGF TKIs in RCC? A: KO-2806 is seen as highly synergistic with current treatments, potentially offering deeper, longer, and higher response rates. We aim to augment current treatment paradigms, providing additional therapeutic options in RCC. - Mollie Leoni, Chief Medical Officer Q: What are the gating steps before initiating the Phase 3 KOMET-017 trial, and how is the reception from trial investigators? A: We are in study startup, focusing on contracting, budgeting, and site initiation. Investigators are positive about ziftomenib, noting that patients feel the same or better on the therapy. We anticipate excitement to build as more data is shared. - Troy Wilson, CEO and Mollie Leoni, Chief Medical Officer For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Washington Post
26-02-2025
- Business
- Washington Post
Kura Oncology: Q4 Earnings Snapshot
SAN DIEGO — SAN DIEGO — Kura Oncology Inc. (KURA) on Wednesday reported a loss of $19.2 million in its fourth quarter. On a per-share basis, the San Diego-based company said it had a loss of 22 cents. The results topped Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 63 cents per share.
