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Kura Oncology Announces Issuance Of U.S. Patent For Lead Product Candidate Tipifarnib In Head And Neck Cancer



7/18/2017 10:48:29 AM

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- New Patent Provides Exclusivity to 2036

SAN DIEGO, July 18, 2017 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced that the United States Patent and Trademark Office has issued a patent protecting the company's lead product candidate, tipifarnib, which is currently being studied in multiple Phase 2 clinical trials. The patent includes multiple claims directed to the use of tipifarnib in patients with HRAS mutant squamous cell carcinoma of the head and neck (SCCHN) and has an expiration date of August 2036, excluding any possible patent term extension.

“Our goal is to identify genetically-defined patient populations in which tipifarnib will demonstrate enhanced therapeutic activity and to pursue patent protection in those indications,” said Troy Wilson, Ph.D., President and CEO of Kura Oncology. “The granting of this new patent is a major milestone for Kura, and it illustrates the potential of our broader strategy to generate intellectual property related to tipifarnib and its use in treating human diseases.”

U.S. Patent No. 9,707,221, entitled “Methods of Treating Cancer Patients with Farnesyltransferase Inhibitors” is directed to the use of tipifarnib for treating patients with relapsed and/or refractory HRAS SCCHN.

About HRAS Mutant SCCHN

Head and neck cancer is one of the leading causes of cancer-related deaths worldwide, with squamous cell carcinomas accounting for most head and neck cancers. The relapsed and/or refractory SCCHN patient population has an overall survival of approximately 6-8 months and few therapeutic options. New therapies for SCCHN, including immunotherapy, typically show a response rate in the range of 10-20%. HRAS is a proto-oncogene that has been implicated in the development and progression of SCCHN. HRAS mutant SCCHN has an estimated annual incidence of approximately 2,800 to 3,400 patients in the U.S. and represents a significant unmet medical need.

About Tipifarnib

Kura Oncology’s lead program, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura Oncology is seeking to identify patients most likely to benefit from tipifarnib.

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 potential activity, tolerability and utility of tipifarnib, the conduct, results and timing of pre-clinical studies and clinical trials, plans regarding future research and development activities and expectations regarding intellectual property and biomarkers related to tipifarnib. 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 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," "might," "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.

CONTACT INFORMATION INVESTOR CONTACT: Robert H. Uhl Managing Director Westwicke Partners, LLC (858) 356-5932 robert.uhl@westwicke.com CORPORATE COMMUNICATIONS CONTACT: Mark Corbae Vice President Canale Communications (619) 849-5375 mark@canalecomm.com


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