Kura Oncology Reports Updated Clinical Activity Data in Ongoing Phase 2 Trial for Tipifarnib

LA JOLLA, Calif., March 06, 2017 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced updated results from the ongoing, Phase 2 trial of tipifarnib, a selective inhibitor of farnesyl transferase, and additional preclinical data in HRAS mutant squamous cell carcinomas of the head and neck (SCCHN). The data were presented today at the 15th International Congress on Targeted Anticancer Therapies (TAT 2017) in Paris, France.

This update on the patients in the first stage of the second cohort of the Phase 2 clinical trial in HRAS mutant tumors reported that, as of February 28, 2017, the two patients with HRAS mutant SCCHN with objective responses remain on study and are currently at treatment cycle 19 and cycle 12. Among the five patients with HRAS mutant salivary gland cancer, although no objective responses were observed, three patients experienced disease stabilization and were on study for 9, 10 and 14 cycles. In addition, tipifarnib was generally well tolerated with adverse events consistent with its known safety profile.

“The durability of the responses we have observed with tipifarnib is compelling considering the setting of relapsed and/or refractory SCCHN,” said Alan L. Ho, M.D., Ph.D., a medical oncologist at Memorial Sloan Kettering Cancer Center and a lead investigator on the study.  “These data reinforce the relevance of testing for HRAS mutations in these patients.”

“We are very encouraged by the durable responses we have observed in patients with relapsed and/or refractory HRAS mutant SCCHN who are treated with tipifarnib,” said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. “The two patients with partial responses have now been on treatment with tipifarnib for more than 16 months and 10 months, respectively. Recruitment of patients with SCCHN has become more challenging in the United States with the approval of immune therapy agents. To facilitate enrollment in the second stage of our trial we are adding additional clinical sites in Western Europe and Asia, and are working with third party laboratories to facilitate HRAS screening. We anticipate that additional results from this ongoing Phase 2 trial of tipifarnib in HRAS mutant SCCHN will be available during the second half of 2017.”

Dr. Ho’s slide presentation will be available at https://tatcongress.org.

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. The pipeline includes KO-947, an ERK inhibitor, and KO-539, an inhibitor of the menin-MLL protein-protein interactions. 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 potential utility of tipifarnib and the Company’s other product candidates, the conduct, results and timing of clinical trials, the timing of the release of clinical trial results, and plans regarding future research and development activities. 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 any difficulty enrolling patients in the Company’s Phase 2 clinical trials could delay or prevent further development and increase costs, the risk that Kura Oncology may not obtain approval to market its product candidates, uncertainties associated with regulatory filings and applications, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on third parties to successfully conduct clinical trials within and outside the United States and for development and commercialization of product candidates. 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.


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