On April 7, 2017 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported 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) (Press release, Kura Oncology, APR 7, 2017, View Source [SID1234518509]).

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"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 (Free AACR Whitepaper) 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.