Ziftomenib

– Ziftomenib induces insulin production, improves insulin sensitivity and reduces insulin resistance in preclinical model of type 2 diabetes – – Kura advancing multiple, next-generation menin inhibitor drug candidates targeting diabetes and other metabolic diseases – 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. 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. “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.” 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. 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. 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. Meanwhile, the Company continues to make progress toward multiple next-generation menin inhibitor drug candidates, targeting diabetes and other metabolic diseases. About Type 2 Diabetes 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. 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. 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. About Kura Oncology 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 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. 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). For additional information, please visit Kura’s website at and follow us on X and LinkedIn. Forward-Looking Statements 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. 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. 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. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at . Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Investors: Pete De Spain Executive Vice President, Investor Relations & Corporate Communications (858) 500-8833 pete@kuraoncology.com Media: Alexandra Weingarten Associate Director, Corporate Communications & Investor Relations (858) 500-8822 alexandra@kuraoncology.com