SAN DIEGO - Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company, announced its participation in the upcoming American Society of Hematology (ASH) Annual Meeting, scheduled from December 7-10, 2024, in San Diego. The company will present clinical data from the KOMET-007 trial, focusing on ziftomenib, its menin inhibitor, in acute myeloid leukemia (AML) patients.
The KOMET-007 trial, a multicenter Phase 1 study, evaluates ziftomenib in combination with standard care therapies in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) AML. The presentations at ASH will cover the Phase 1a dose-escalation segment of the trial, involving newly diagnosed patients with adverse risk AML in combination with 7+3 (cytarabine plus daunorubicin) and relapsed/refractory (R/R) patients with venetoclax/azacitidine (ven/aza).
All four cohorts in the Phase 1a dose-escalation study have progressed to the Phase 1b expansion study at a 600 mg dose. The company reports that ziftomenib has shown a potential best-in-class safety and tolerability profile, as well as durable activity in combination with standard care.
Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology, stated that the combination of ziftomenib with ven/aza is well tolerated and shows encouraging activity in R/R patients, including those previously exposed to venetoclax. He also noted the high rates of complete response and MRD negativity in the frontline AML population.
As of the June 21st data cutoff, 100% (15/15) of the NPM1-m AML patients and 84% (16/19) of the KMT2A-r patients remained on study, indicating the potential for ziftomenib to transform the standard of care in these high-risk patients. More mature data from over 100 patients, including those from the 600 mg cohorts, will be shared at the ASH Annual Meeting.
The presentations at the ASH meeting will include an oral session on Saturday, December 7, and a poster presentation on Sunday, December 8. The data will be available on Kura's website following the meeting.
Kura Oncology is focused on developing precision medicines for cancer treatment. Its pipeline includes small molecule drug candidates targeting cancer signaling pathways. Ziftomenib has received Breakthrough Therapy Designation for the treatment of R/R NPM1-m AML.
The information reported is based on a press release statement from Kura Oncology.
In other recent news, Kura Oncology has been the subject of several major developments. The company has reported promising preclinical data for its menin inhibitor, ziftomenib, in treating advanced gastrointestinal stromal tumors, with a Phase 1 clinical trial set to commence in 2025. Kura Oncology also reported a net loss of $50.8 million for the quarter due to increased research and development expenses, but its strong cash position of $491.5 million is expected to fund operations into 2027.
Analyst firms have had differing views on Kura Oncology's prospects. H.C. Wainwright maintained a Buy rating on the company's shares, citing confidence in ziftomenib's therapeutic potential. UBS also initiated coverage with a Buy rating, expressing optimism about ziftomenib's potential in the acute myeloid leukemia market. However, Stifel downgraded the company's stock from Buy to Hold due to anticipated challenges for ziftomenib in gaining market share against competitors.
Kura Oncology has also seen changes in its leadership, with the addition of Michael J. Vasconcelles, M.D., to its board, who brings over 25 years of oncology drug development experience. These recent developments underscore Kura Oncology's commitment to advancing its oncology pipeline.
InvestingPro Insights
As Kura Oncology (NASDAQ:KURA) prepares to present clinical data at the upcoming ASH Annual Meeting, investors may find additional context from InvestingPro's financial metrics and tips particularly relevant.
According to InvestingPro data, Kura Oncology has a market capitalization of $1.36 billion, reflecting investor interest in its potential cancer treatments. The company's focus on developing precision medicines like ziftomenib aligns with its current financial position. An InvestingPro Tip notes that Kura "holds more cash than debt on its balance sheet," which is crucial for a clinical-stage biopharmaceutical company funding ongoing research and development.
Despite the promising clinical data mentioned in the article, it's important to note that Kura is not yet profitable. An InvestingPro Tip indicates that analysts do not anticipate the company will be profitable this year. This is typical for biotech companies in the development stage, as they invest heavily in clinical trials before generating significant revenue.
Interestingly, Kura has seen a high return over the last year, with InvestingPro data showing a one-year price total return of 97.67%. This suggests that investors are optimistic about the company's pipeline and potential, particularly with ziftomenib's Breakthrough Therapy Designation for R/R NPM1-m AML.
For those interested in a deeper analysis, InvestingPro offers 7 additional tips for Kura Oncology, providing a more comprehensive view of the company's financial health and market position.
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