Kura Oncology Announces FDA Clearance of IND Application for KO-2806, a Next-Generation Farnesyl Transferase Inhibitor
"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
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.
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.
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 efficacy, safety and therapeutic potential of KO-2806, potential benefits of combining KO-2806 with appropriate standards of care, and progress and expected timing of the KO-2806 program and clinical trials. 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 may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. 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
Senior Vice President, Investor Relations &
Senior Manager, Corporate Communications
Source: Kura Oncology, Inc.