SAN DIEGO - Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ziftomenib. This clearance sets the stage for a first-in-human study of ziftomenib in combination with imatinib for the treatment of advanced gastrointestinal stromal tumors (GIST), slated to begin in early 2025.
This marks the first IND approval for a menin inhibitor in the treatment of GIST, a type of sarcoma where treatment options are currently limited for patients with advanced disease. Imatinib, the standard care for GIST patients, often leads to resistance over time. Preclinical studies suggest that ziftomenib could potentially resensitize patients to imatinib and induce durable responses in cases where imatinib has failed.
Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology, expressed optimism about the upcoming clinical study and the potential benefits of the drug combination. The company anticipates presenting the preclinical data at a future scientific meeting.
GIST is the most common sarcoma, with KIT inhibitors like imatinib being associated with favorable outcomes. However, patients who progress on imatinib have few subsequent treatment options, which are often limited by moderate efficacy and challenging tolerability. The menin-MLL complex is known to regulate KIT expression in GIST cells, and menin inhibitors have shown additive therapeutic activity with imatinib in sensitive GIST models.
Kura Oncology's pipeline also includes other small molecule drug candidates targeting cancer signaling pathways. Ziftomenib has received Breakthrough Therapy Designation for the treatment of relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), and the company is conducting clinical trials to evaluate this drug in various AML contexts. Additionally, Kura is working on other clinical trials, including a combination treatment for head and neck squamous cell carcinoma.
In other recent news, H.C. Wainwright and Stifel have both maintained a positive stance on Kura Oncology, reiterating a Buy rating with a price target of $32 and $28 respectively. These endorsements reflect confidence in the potential market performance of Kura Oncology's stock and the therapeutic prospects of ziftomenib.
In other developments, Kura Oncology reported a net loss of $49.5 million for the first quarter of 2024 but maintains a robust financial position with $527 million in cash reserves.
InvestingPro Insights
As Kura Oncology, Inc. (NASDAQ:KURA) forges ahead with its groundbreaking IND for ziftomenib, financial metrics and analyst insights from InvestingPro provide a deeper understanding of the company's current market position. Kura Oncology holds a market capitalization of approximately $1.41 billion, reflecting investor confidence in its potential despite the absence of profitability in the last twelve months. The company's commitment to innovation in cancer treatment is mirrored in its InvestingPro Tip that it holds more cash than debt on its balance sheet, indicating a solid financial foundation to support its clinical trials and research endeavors.
InvestingPro Data further reveals a Price to Book ratio of 2.8 as of Q1 2024, suggesting that investors are valuing the company at nearly three times its book value, possibly due to the promising developments in its drug pipeline. However, the company's P/E ratio stands at -8.54, underscoring the current lack of earnings. Despite this, Kura's stock has experienced a significant return of 78.56% over the past year, showcasing strong investor optimism for its future prospects.
InvestingPro Tips highlight the cautionary sentiment among analysts, with nine analysts having revised their earnings downwards for the upcoming period, indicating potential headwinds or recalibrated expectations for Kura's financial performance. For those interested in a comprehensive analysis, InvestingPro offers additional tips, with a total of 10 tips available on Kura Oncology, which can be accessed to gain further insights into the company's financial health and market potential.
Overall, while Kura Oncology navigates through the clinical and regulatory landscape, these financial metrics and analyst insights can help investors keep a pulse on the company's market standing and future outlook.
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