Kura Oncology (KURA) Announces FDA Clearance of IND Application for KO-2806


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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 U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) for KO-2806, the company’s next-generation farnesyl transferase inhibitor (FTI), for the treatment of advanced solid tumors. The company intends to evaluate the safety, tolerability and preliminary antitumor activity of KO-2806 in a first Phase 1 human study as a monotherapy and in combination with other targeted therapies.

“While we’ve seen significant advances in the development of targeted therapies to treat a variety of solid tumors, the reality is that most patients still eventually develop resistance and their cancer progresses with therapy,” said Troy Wilson, Ph.D., JD , President and CEO of Kura Oncology. “In recent years, we have pioneered the development of farnesyl transferase inhibitors as combination agents to prevent or delay the emergence of resistance to certain classes of targeted therapy. The release 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 first Phase 1 human study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 when administered as monotherapy and in combination therapy in adult patients with advanced solid tumors. Upon completion of dose escalation as monotherapy, Kura plans to evaluate KO-2806 in dose escalation combination cohorts in advanced solid tumors. The Company expects to begin the Phase 1 study in the third quarter of 2023.

About KO-2806

KO-2806 is a potent next-generation farnesyl transferase inhibitor designed to improve the 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) through farnesyl transferase inhibition with tipifarnib and is currently evaluating tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of patients with HNSCC. In addition, preclinical data support FTIs in combination with other targeted therapies to potentially overcome or prevent the emergence of 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 girl inhibitor, is currently in development for patients with acute myelogenous leukemia with NPM1 mutation and KMT2A rearrangement. Tipifarnib, a potent, selective, and orally bioavailable FTI, has received breakthrough therapy designation for the treatment of patients with HRAS mutant HNSCC. Kura is leading a Phase 1/2 study (KURRENT-HN) of tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of patients with HNSCC, including those whose tumors are dependent on the HRAS and/or PI3Kα pathways. The company also initiated a Phase 1 study (KURRENT-LUNG) of tipifarnib in combination with osimertinib in EGFR mutant non-small cell lung cancer. Kura intends to conduct initial clinical evaluation with tipifarnib while parallelly advancing KO-2806, the company’s next-generation FTI, through a Phase 1 human-first study. For additional information, visit Kura’s website at www.kuraoncology.com.

Forecast Statements

This press release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from historical results or 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 could cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials will not demonstrate safety and/or efficacy in preclinical studies or later clinical trials, the risk that Kura does not gain approval to market its product candidates, uncertainties associated with conducting clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, risks associated with reliance on external funding 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 therapies and in an effort to build a business around these drugs. You should consider statements that include the words “may”, “will”, “would”, “could”, “should”, “believes”, “estimates”, “projects”, “promises”, “potential” “expects” , “plans”, “anticipates”, “intends”, “continues”, “designed”, “objective” or the negative of these words or other comparable words to be uncertain and prospective. For a further listing and description of the risks and uncertainties facing the Company, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission (SEC), including the Company’s Form 10-Q for the quarter ended September 30 of 2022 filed with the SEC on November 3, 2022, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Investors: Pete De Spain Senior Vice President, Investor Relations and Corporate Communications(858) 500-8803[email protected]

Media: Alexandra Weingarten Senior Manager, Corporate Communications (858) 500-8822[email protected]

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Source: Kura Oncology, Inc.

Kura Oncology (KURA) Announces FDA Clearance of IND Application for KO-2806

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