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San Diego, CA, USA | January 24, 2023 | Kura Oncology, Inc. (Nasdaq: KURA), a clinical-phase biopharmaceutical enterprise dedicated to harnessing the potential of precision medicines for treating cancer, today reported the U.S. Food and Drug Administration (FDA)'s approval of the Investigational New Drug (IND) application for KO-2806. This is the company's futuristic farnesyl transferase inhibitor (FTI) aimed at treating advanced solid tumors. The company plans to assess the safety, tolerability, and initial antitumor efficacy of KO-2806 in a Phase 1 first-in-human trial as a standalone therapy and in conjunction with other precision therapies.
A Leap Forward in Cancer Treatment
"In spite of significant progress in the creation of targeted therapies for treating various solid tumors, the harsh reality is that most patients eventually develop resistance, and their cancer advances on therapy," said Troy Wilson, Ph.D., J.D., President & Chief Executive Officer of Kura Oncology.
Over the past few years, Kura Oncology has been at the forefront of developing farnesyl transferase inhibitors as combination agents to delay or prevent the emergence of resistance to certain classes of targeted therapy. The approval of the IND for KO-2806 represents a significant milestone for this program, and the company looks forward to commencing the Phase 1 trial later this year.
The Phase 1 First-In-Human Study
The Phase 1 first-in-human study is planned to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of KO-2806 as a standalone therapy and in combination therapy in adult patients with advanced solid tumors. Post the completion of the dose escalation as a standalone therapy, Kura intends to assess KO-2806 in dose escalation combination cohorts in advanced solid tumors. The initiation of the Phase 1 trial is expected in the third quarter of 2023.
KO-2806: A Potent Next-Generation Inhibitor
KO-2806 is a potent next-generation inhibitor of farnesyl transferase formulated to enhance potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. Kura has shown promising clinical activity in HRAS-mutant head and neck squamous cell carcinoma (HNSCC) via farnesyl transferase inhibition with tipifarnib and is currently assessing tipifarnib in combination with the PI3Kα inhibitor alpelisib to cater to larger genetic subsets of HNSCC patients. Additionally, preclinical data backs the use of FTIs in combination with other targeted therapies to potentially overcome or prevent the emergence of drug resistance to certain classes of drugs.
About Kura Oncology
Kura Oncology is a clinical-phase biopharmaceutical company committed to harnessing the potential of precision medicines for treating cancer. The company's pipeline includes small molecule drug candidates that target cancer signaling pathways. Ziftomenib, a potent and selective menin inhibitor, is presently 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 cater to larger genetic subsets of HNSCC patients, encompassing 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 plans to perform the initial clinical evaluation with tipifarnib while simultaneously advancing KO-2806, the company's next-generation FTI, through a Phase 1 first-in-human study.
Indications
Acute Myeloid Leukemia
Solid Tumors
Squamous Cell Carcinoma of Head and Neck
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