Kura Oncology Reports Preclinical Data Highlighting Synergistic Activity of Farnesyl Transferase Inhibitor in Combination with Targeted Therapies

– Preclinical data support the potential for FTIs in combination with KRAS^G12C inhibitors and TKIs to prevent or delay emergence of adaptive resistance –

– Company preparing to initiate Phase 1 dose-escalation trial (FIT-001) of KO-2806, a next-generation FTI –

SAN DIEGO, April 17, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported preclinical data supporting the potential use of farnesyl transferase inhibitors (FTIs) to treat various types of solid tumors in combination with targeted therapies, including KRAS^G12C inhibitors and anti-angiogenic tyrosine kinase inhibitors (TKIs). These data were featured in two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting on Sunday, April 16 in Orlando. Copies of the posters are available on Kura’s website at www.kuraoncology.com/pipeline/publications.

New preclinical data in the poster titled, ‘Tipifarnib synergizes with a TKI in clear cell renal cell carcinoma models,’ demonstrates the synergistic activity of tipifarnib and axitinib, a TKI approved to treat advanced renal cell carcinoma (RCC), in cell- and patient-derived RCC xenograft models. These data support the potential to administer an FTI in combination with a TKI for the treatment of RCC, and studies are ongoing to further evaluate the mechanistic basis of the synergy observed with the combination.

In addition, new findings were presented in the poster titled, ‘Combination of tipifarnib with KRAS^G12C inhibitors to prevent adaptive resistance,’ evaluating the effects of tipifarnib in combination with adagrasib and sotorasib in cell line and xenograft models of KRAS^G12C mutant non-small cell lung cancer (NSCLC). These data reveal that the addition of tipifarnib leads to significant tumor regression in xenograft models and suppresses mTOR signaling reactivation relative to treatment with the KRAS^G12C inhibitors alone. These results support further preclinical studies to determine the mechanism of action for the combination.

“Although targeted therapies have demonstrated meaningful clinical activity, including objective responses, across a range of solid tumors, over time adaptive resistance almost invariably emerges, limiting the ability of the targeted therapies to drive sustained clinical benefit. Yesterday, we presented encouraging preclinical data that highlight the potential for FTIs to prevent or delay emergence of resistance to certain classes of targeted therapies,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We believe these promising preclinical data strongly support our rationale to combine KO-2806 with KRAS^G12C mutant inhibitors and TKIs in NSCLC and RCC, respectively.”

In parallel to the clinical evaluation of tipifarnib, the Company is advancing KO-2806, a potent inhibitor of farnesyl transferase that was designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. The Company expects to initiate the Phase 1 first-in-human study (FIT-001) later this year to assess safety, tolerability and preliminary antitumor activity of KO-2806 as a monotherapy and in combination with other targeted therapies 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.

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 is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. The Company is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) of ziftomenib in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura’s website at www.kuraoncology.com.

Forward-Looking Statements

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 tipifarnib and KO-2806, and progress and expected timing of Kura’s drug development programs. 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 Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes 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 &
Corporate Communications
(858) 500-8833
pete@kuraoncology.com

Media:
Alexandra Weingarten
Senior Manager, Corporate Communications
(858) 500-8822
alexandra@kuraoncology.com