Kura肿瘤学报告支持Menin抑制剂治疗糖尿病潜力的临床前数据-动脉网

Kura Oncology Reports Preclinical Data Supporting Potential for Menin Inhibitor in Diabetes

BioSpace 等信源发布 2024-06-24 19:55

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– Ziftomenib induces insulin production, improves insulin sensitivity and reduces insulin resistance in preclinical model of type 2 diabetes –

–Ziftomenib在2型糖尿病的临床前模型中诱导胰岛素产生，改善胰岛素敏感性并降低胰岛素抵抗–

– Kura advancing multiple, next-generation menin inhibitor drug candidates targeting diabetes and other metabolic diseases –

–Kura推进针对糖尿病和其他代谢疾病的多种下一代menin抑制剂候选药物–

SAN DIEGO, June 24, 2024 (GLOBE NEWSWIRE) -- Kura Oncology Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported preclinical data supporting the potential therapeutic utility of menin inhibitors in the treatment of diabetes.

圣地亚哥，2024年6月24日（环球通讯社）--Kura Oncology Inc.（纳斯达克：Kura），一家致力于实现精准药物治疗癌症的承诺的临床阶段生物制药公司，今天报道了支持menin抑制剂在糖尿病治疗中潜在治疗效用的临床前数据。

The new findings were presented this weekend at the American Diabetes Association’s 84th Scientific Sessions in Orlando. Copies of the presentation are available in the Posters and Presentations section on Kura’s website..

这项新发现于本周末在奥兰多举行的美国糖尿病协会第84届科学会议上公布。。。

“Despite the introduction of multiple options for the treatment of type 2 diabetes, a significant unmet need exists as a large proportion of patients do not achieve glycemic control,” said Francis Burrows, Ph.D., Senior Vice President, Translational Research. “We are encouraged by these preclinical data for ziftomenib in diabetes, which demonstrate the potential for menin inhibitors to enhance pancreatic function and warrant further evaluation in diabetes.”.

转化研究高级副总裁FrancisBurrows博士说：“尽管引入了多种治疗2型糖尿病的方法，但由于大部分患者无法实现血糖控制，因此仍存在大量未满足的需求。”。“我们对ziftomenib在糖尿病中的这些临床前数据感到鼓舞，这些数据证明了menin抑制剂增强胰腺功能的潜力，并需要对糖尿病进行进一步评估。”。

Type 2 diabetes is marked by an inadequate number of functional pancreatic beta cells, which results in insufficient insulin production, leading to hyperglycemia. Ziftomenib demonstrated meaningful levels of glycemic control in preclinical in vivo models, including reduced fasting blood glucose levels and %HbA1C within 27 days as well as consistent improvement in both insulin sensitivity and insulin production.

2型糖尿病的特征是功能性胰腺β细胞数量不足，导致胰岛素产生不足，导致高血糖。Ziftomenib在临床前体内模型中表现出有意义的血糖控制水平，包括在27天内降低空腹血糖水平和糖化血红蛋白百分比，以及胰岛素敏感性和胰岛素产生的持续改善。

The data show that the effects of ziftomenib were fully maintained following dose discontinuation, suggesting restoration of beta-cell mass. A decline in pancreatic beta-cell function and/or mass has been defined as a key contributing factor to disease progression in type 2 diabetes. Notably, in human islet microtissues originating from two donor samples, ziftomenib induced beta-cell proliferation while non-beta-cell proliferation was not detectable, demonstrating menin is a viable therapeutic target for beta-cell mass specific expansion..

数据显示，停用剂量后，ziftomenib的作用得以完全维持，表明β细胞质量得以恢复。胰腺β细胞功能和/或质量的下降已被定义为2型糖尿病疾病进展的关键因素。值得注意的是，在源自两个供体样品的人胰岛微组织中，ziftomenib诱导β细胞增殖，而未检测到非β细胞增殖，表明menin是β细胞质量特异性扩增的可行治疗靶标。。

Kura’s first-generation menin inhibitor, ziftomenib, is currently in clinical development as both a monotherapy and in combination with standards of care for the treatment of acute leukemias, and it recently received Breakthrough Therapy Designation for the treatment of relapsed/refractory (R/R) NPM1-mutant AML.

Kura的第一代menin抑制剂ziftomenib目前正在临床开发中，既可以作为单一疗法，也可以与治疗急性白血病的护理标准相结合，最近它获得了治疗复发/难治性（R/R）NPM1突变AML的突破性治疗指定。

Meanwhile, the Company continues to make progress toward multiple next-generation menin inhibitor drug candidates, targeting diabetes and other metabolic diseases..

与此同时，该公司在针对糖尿病和其他代谢疾病的多种下一代menin抑制剂候选药物方面继续取得进展。。

About Type 2 Diabetes

关于2型糖尿病

Diabetes mellitus is characterized by a reduced ability of the body to produce insulin and/or by a dysregulated response to insulin. Diabetes is grouped into two clinical categories according to the American Diabetes Association (ADA) – type 1 diabetes and type 2 diabetes – the latter accounting for 25.3 million diagnosed patients in the U.S.

糖尿病的特征是身体产生胰岛素的能力降低和/或对胰岛素的反应失调。根据美国糖尿病协会（ADA），糖尿病分为两个临床类别-1型糖尿病和2型糖尿病-后者在美国占2530万确诊患者。

A decline in pancreatic beta-cell function and/or mass has been defined as a key contributing factor to disease progression in type 2 diabetes. Loss of functional beta-cell mass is a core component of the natural history in type 2 diabetes (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin.

胰腺β细胞功能和/或质量的下降已被定义为2型糖尿病疾病进展的关键因素。功能性β细胞质量的丧失是2型糖尿病（由代谢功能障碍介导）自然史的核心组成部分。β细胞存在于胰腺中，负责胰岛素的合成和分泌。

Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. Although glycemic control is a validated approach to delaying disease progression, many patients do not achieve glycemic control, which can lead to significant and potentially fatal renal, cardiac, neurological, and ophthalmic comorbidities..

胰岛素是一种帮助身体利用葡萄糖获取能量并帮助控制血糖水平的激素。尽管血糖控制是延缓疾病进展的有效方法，但许多患者无法实现血糖控制，这可能导致严重且可能致命的肾脏，心脏，神经和眼科合并症。。

About Kura Oncology

关于库拉肿瘤学

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML).

Kura Oncology是一家临床阶段的生物制药公司，致力于实现精准药物治疗癌症的承诺。该公司的管道由靶向癌症信号传导途径的小分子候选药物组成。Ziftomenib是一种每日一次的靶向menin-KMT2A蛋白-蛋白相互作用的口服候选药物，已被指定用于治疗R/R NPM1突变型急性髓细胞白血病（AML）。

Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML.

。该公司还正在进行一系列临床试验，以评估ziftomenib与新诊断和R/R NPM1突变和KMT2A重排AML的当前护理标准相结合。

Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001).

Tipifarnib是一种有效的选择性法尼基转移酶抑制剂（FTI），目前正在与alpelisib联合进行1/2期试验，用于PIK3CA依赖性头颈部鳞状细胞癌（KURRENT-HN）患者。Kura还在1期剂量递增试验中评估下一代FTI KO-2806作为单一疗法并与靶向疗法（FIT-001）联合使用。

For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn..

有关更多信息，请访问Kura的网站www.kuraoncology.com，并通过X和LinkedIn关注我们。。

Forward-Looking Statements

前瞻性声明

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 statements regarding, among other things, the efficacy, safety and therapeutic potential of ziftomenib, potential benefits of combining ziftomenib with appropriate standards of care, and progress and expected timing of the ziftomenib program and clinical trials.

本新闻稿包含某些涉及风险和不确定性的前瞻性陈述，这些风险和不确定性可能导致实际结果与历史结果或此类前瞻性陈述所表达或暗示的任何未来结果存在重大差异。这些前瞻性声明包括关于ziftomenib的疗效，安全性和治疗潜力，将ziftomenib与适当的护理标准相结合的潜在益处以及ziftomenib计划和临床试验的进展和预期时间的声明。

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, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, 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.

可能导致实际结果产生重大差异的因素包括：在早期研究或临床试验中看起来有希望的化合物在后来的临床前研究或临床试验中没有显示出安全性和/或有效性的风险，Kura可能无法获得批准以销售其候选产品的风险，与进行临床试验，监管备案，应用以及与监管机构的其他互动相关的不确定性，与依赖第三方成功进行临床试验相关的风险，与依赖外部融资以满足资本要求相关的风险，以及与发现，开发和商业化安全有效用作人类治疗药物的过程相关的其他风险，以及围绕这些药物建立业务的努力。

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.

强烈建议您考虑包含“可能”、“将”、“将”、“可能”、“应该”、“相信”、“估计”、“项目”、“承诺”、“潜力”、“期望”、“计划”、“预期”、“打算”、“继续”、“设计”、“目标”或这些词语或其他类似词语的否定词的陈述，以确定其不确定性和前瞻性。

For a further list and description of the r.

有关r的进一步列表和描述。

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