Kura Oncology Development Candidate KO-539 Shows Robust Preclinical Anti-Tumor Activity in NPM1- and DNMT3A-Mutant AML

  • NPM1 and DNMT3A-mutants comprise approximately 45% of AML patients
  • Menin-MLL complex appears to be central node in epigenetic dysregulation giving rise to AML

SAN DIEGO, Oct. 28, 2017 (GLOBE NEWSWIRE) -- Kura Oncology. (Nasdaq:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced new results for KO-539, the company’s potent and selective inhibitor of the menin-MLL protein-protein interaction, which is currently in preclinical development as a potential treatment for patients with genetically-defined subsets of acute leukemias. The results were featured in a late-breaking presentation today at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

Although KO-539 was originally designed as a potential therapy for the MLL-rearranged leukemias, the new results demonstrate significant activity in preclinical models of additional genetically-defined subsets of AML, including those with oncogenic driver mutations in NPM1, IDH1, IDH2 and DNMT3A. Preliminary pharmacodynamic data suggests that KO-539 exerts anti-leukemic activity by induction of myeloid differentiation in AML blasts, a mechanism that is distinct from and potentially complementary to existing cytotoxic and antiproliferative therapies. The menin-MLL complex appears to be a central node in epigenetic dysregulation driven by several distinct oncogenic driver mutations known to be important in diverse leukemias and myeloproliferative disorders.

“Although AML is a relatively common hematologic malignancy with a generally poor prognosis, the development of novel therapeutic approaches has been hampered by the many different genetic and clinical subgroups found in the disease and the relatively short durations of response,” said Yi Liu, Ph.D., Chief Scientific Officer, Kura Oncology. “We’re encouraged by the results presented today because they demonstrate that menin-MLL inhibitors have the potential to be active in subtypes representing approximately half of the patients with AML and drive robust and persistent responses in preclinical models.”

A copy of the poster, entitled “A novel small molecule menin-MLL inhibitor for potential treatment of MLL-rearranged leukemias and NPM1/DNMT3A-mutant AML,” is now available on the company’s website at www.kuraoncology.com.

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 where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple Phase 2 clinical trials. Kura’s pipeline also includes KO-947, an ERK inhibitor, currently in a Phase 1 trial, and KO-539, an inhibitor of the menin-MLL protein-protein interaction, currently in preclinical testing. For additional information about Kura Oncology, please visit the company’s website at www.kuraoncology.com.

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 KO-539, progress and expected timing of Kura Oncology’s drug development programs and clinical trials and plans regarding future clinical trials and development activities. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or preclinical studies do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura Oncology may not obtain approval to market its product candidates, uncertainties associated with performing preclinical studies, clinical trials, regulatory filings and applications, 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 www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.



Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932


Mark Corbae
Vice President
Canale Communications
(619) 849-5375

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