Kura Oncology Announces FDA Clearance of IND Application for KO-2806, a Next-Generation Farnesyl Transferase Inhibitor

SAN DIEGO, CA, USA I January 24, 2023 I Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced the clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for KO-2806, the Company's next-generation farnesyl transferase inhibitor (FTI), for the treatment of advanced solid tumors. The Company intends to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 first-in-human study as a monotherapy and in combination with other targeted therapies.

"Although we have seen significant advances in the development of targeted therapies for the treatment of various solid tumors, the reality is that most patients still eventually develop resistance and their cancer progresses on therapy," said Troy Wilson, Ph.D., J.D., President & Chief Executive Officer of Kura Oncology. "Over the past several years, we have pioneered the development of farnesyl transferase inhibitors as combination agents to prevent or delay emergence of resistance to certain classes of targeted therapy. Clearance of the IND for KO-2806 marks an important next step for this program, and we look forward to starting the Phase 1 study later this year.”

The Phase 1 first-in-human study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 when administered as a monotherapy and in combination therapy in adult patients with advanced solid tumors. Following completion of the dose escalation as a monotherapy, Kura plans to evaluate KO-2806 in dose escalation combination cohorts in advanced solid tumors. The Company expects to initiate the Phase 1 study in the third quarter of 2023.

About KO-2806

KO-2806 is a potent next-generation inhibitor of farnesyl transferase designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. Kura has demonstrated encouraging clinical activity in HRAS-mutant head and neck squamous cell carcinoma (HNSCC) via farnesyl transferase inhibition with tipifarnib and is currently evaluating tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of HNSCC patients. In addition, preclinical data is supportive of FTIs in combination with other targeted therapies to potentially overcome or prevent emergence of drug resistance to certain classes of drugs.

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. Ziftomenib, a potent and selective menin inhibitor, is currently in development for patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia. Tipifarnib, a potent, selective and orally bioavailable FTI, has received Breakthrough Therapy Designation for the treatment of patients with HRAS-mutant HNSCC. Kura is conducting a Phase 1/2 trial (KURRENT-HN) of tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of HNSCC patients, including those whose tumors are dependent on HRAS and/or PI3Kα pathways. The Company has also initiated a Phase 1 trial (KURRENT-LUNG) of tipifarnib in combination with osimertinib in EGFR-mutant non-small cell lung cancer. Kura intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, the Company’s next-generation FTI, through a Phase 1 first-in-human study. For additional information, please visit Kura’s website at www.kuraoncology.com.

SOURCE: Kura Oncology

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