$KURA Doses First Patient in Phase 1 Trial of ERK Inhibitor KO-947

LA JOLLA, Calif., April 07, 2017  — Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced that the first patient has been dosed in its Phase 1 clinical trial of  KO-947, a potent and selective small molecule inhibitor of extracellular-signal-regulated kinases 1 and 2 (ERK1/2).

“We are committed to the discovery and development of product candidates that target oncogenes and oncogenic pathways for the treatment of cancer,” said Troy Wilson, Ph.D., J.D., President and CEO of Kura. “We believe KO-947 holds much promise as a potential therapeutic, and its advancement into the clinic underscores Kura’s productivity and commitment to building a diverse pipeline of precision medicines.”

“The RAS/RAF/MEK/ERK pathway is dysregulated in more than 30% of human cancers, including tumors arising from mutations in KRAS, NRAS and BRAF, encompassing a number of cancer indications with significant unmet medical need,” said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura. “We believe the unique and differentiated drug properties of KO-947, as well as a significant body of preclinical data including data just presented at the AACR meeting this week, make it a compelling therapeutic candidate, and we look forward to evaluating its tolerability and activity in the clinic.”

The Phase 1 trial of KO-947 is designed to determine the maximum tolerated dose of KO-947 in patients with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. The trial design includes a dose escalation, maximum–tolerated dose expansion and one or more tumor-specific extension cohorts. Currently, two tumor-specific cohorts, non-small cell lung cancer with mutations in RAS or BRAF and squamous cell carcinomas, have been identified as potential extension cohorts. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT03051035

About KO-947

KO-947 is a potent and selective small molecule inhibitor of ERK1/2 kinases. KO-947 exhibits potent anti-proliferative activity across a broad panel of tumor cell lines with mutations in BRAF, NRAS or KRAS and demonstrates prolonged pathway inhibition, both in vitro and in vivo. Durable tumor regression has been observed with KO-947 in preclinical cell line and patient derived xenograft models, including KRAS- and BRAF-mutant adenocarcinomas and squamous cell carcinomas lacking BRAF/RAS mutations.

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 utility of KO-947, the conduct, results and timing of preclinical studies and clinical trials and plans regarding future research and development. 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 collaborative partners for further research, clinical trials, 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.

 

CONTACT INFORMATION

INVESTOR CONTACT:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com

MEDIA CONTACT:
Mark Corbae
Vice President
Canale Communications
(619) 849-5375
mark@canalecomm.com