Kura Oncology Reports Preclinical Data Showing Ability of KO-2806 to Enhance Antitumor Activity of KRASᴳ¹²ᶜ Inhibitors in Non-Small Cell Lung Cancer

Rhea-AI Summary

Kura Oncology presents preclinical data supporting the development of its next-generation FTI KO-2806 in combination with KRASG12C inhibitors for the treatment of KRASG12C-mutant NSCLC. The data show deepened signaling inhibition and decreased cell proliferation, leading to tumor regressions in preclinical models. The combination therapy also demonstrated enhanced duration and depth of antitumor response compared to adagrasib alone. Kura plans to dose the first patient in its Phase 1 trial of KO-2806 in the second half of 2023.

Positive

• Preclinical data supports development of KO-2806 in combination with KRASG12C inhibitors for NSCLC treatment
• Tumor regressions observed in preclinical models
• Enhanced antitumor response compared to adagrasib alone

Negative

• None.

– Oral presentation at RAS Summit supports development of next-generation FTI in combination with KRAS^G12C inhibitors –

– Company to include KRAS^G12C-mutant NSCLC in combination portion of Phase 1 clinical trial of KO-2806 (FIT-001) –

SAN DIEGO, Sept. 28, 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 development of its next-generation farnesyl transferase inhibitor (FTI) KO-2806 in combination with KRAS^G12C inhibitors to drive tumor regressions and durable responses in KRAS^G12C-mutant non-small cell lung cancer (NSCLC).

The new findings are being presented in an oral session today at the 5^th RAS-Targeted Drug Development Summit in Boston. A copy of the presentation, entitled “Farnesyl Transferase Inhibitors – Evolution from Targeting HRAS to Overcoming Adaptive Resistance to Targeted Therapies,” is available in the Posters and Presentations section on Kura’s website.

KRAS^G12C inhibitors have previously been shown to activate RTK signaling, leading to ERK-RSK and/or mTOR-S6 pathway reactivation. The Company’s new preclinical data show that co-treatment of preclinical models of KRAS^G12C-mutant NSCLC with KO-2806 and adagrasib deepens signaling inhibition at multiple nodes, including the MAPK and mTOR pathways, while decreasing cell proliferation. In both cell-derived (CDX) and patient-derived (PDX) xenograft models originating from NSCLC tumors, the combination of KO-2806 with adagrasib induced tumor regressions. In addition, the CDX and PDX models demonstrated enhanced duration and depth of antitumor response compared to adagrasib as a single-agent therapy.

“Despite advances with KRAS-targeted therapies, a significant unmet need remains for patients with KRAS^G12C-mutant NSCLC as acquired resistance occurs early and often,” said Francis Burrows, Ph.D., Senior Vice President, Translational Research. “We are highly encouraged by these first preclinical data for KO-2806, which demonstrate the potential for FTIs as a mechanism-based combination agent to enhance antitumor activity of targeted therapies, such as KRAS^G12C inhibitors.”

Kura is on track to dose the first patient in its Phase 1 dose-escalation trial of KO-2806 (FIT-001) in the second half of 2023. Concurrent with the monotherapy dose escalation, the Company plans to evaluate KO-2806 in dose-escalation combination cohorts with other targeted therapies in advanced solid tumors, including clear cell renal cell carcinoma (ccRCC) and KRAS^G12C NSCLC.

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 acute myeloid leukemia (AML) patients with high unmet need. Kura is currently enrolling patients in a Phase 2 registration-directed trial of ziftomenib in NPM1-mutant relapsed or refractory AML (KOMET-001). The Company is also conducting a series of studies to evaluate ziftomenib in combination with current standards of care, beginning with venetoclax/azacitidine and standard induction cytarabine/daunorubicin chemotherapy in NPM1-mutant and KMT2A-rearranged newly diagnosed and relapsed/refractory AML (KOMET-007). Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also preparing to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with other targeted therapies, beginning with ccRCC and KRAS^G12C-mutant NSCLC (FIT-001). For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on Twitter and LinkedIn.

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 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 Securities and Exchange Commission (SEC), including the Company’s Form 10-Q for the quarter ended June 30, 2023 filed with the SEC on August 9, 2023, 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
Executive 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