On October 18, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported new preliminary data from its farnesyl transferase inhibitor (FTI) programs – darlifarnib (KO-2806) and tipifarnib – presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany, from October 17 – 21, 2025.

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"Kura Oncology is pioneering the use of FTIs in combination with tyrosine kinase inhibitors (TKIs), PI3Kα inhibitors and KRAS inhibitors to address mechanisms of innate and adaptive resistance, thereby enhancing and extending the clinical benefit of these single-agent targeted therapies," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "The clinical data reported here at ESMO (Free ESMO Whitepaper) 2025 build on our preclinical presentation from last month and underscore darlifarnib’s transformative potential as a versatile combination partner to major classes of precision medicines."

Darlifarnib as Monotherapy in Advanced Solid Tumors – FIT-001 Phase 1 Trial

HRAS-mutant (HRAS-m) tumors are sensitive to FTIs
Manageable safety and tolerability profile at doses from 3 to 10 mg per day
Encouraging antitumor activity in advanced HRAS-m solid tumors across multiple dose levels, demonstrating on-target activity and a broad therapeutic window
Data support further evaluation of KO-2806 in combinations across tumor types

Darlifarnib + Cabozantinib in Renal Cell Carcinoma – FIT-001 Phase 1 Trial

FTI mechanism blocks hyperactivated mTORC1 signaling in tumor endothelial cells
Manageable safety profile in RCC patients across multiple doses, including at the full label dose of cabozantinib
Antitumor activity observed across all doses in RCC, including in prior cabozantinib-exposed patients
ORR: 33%–50% in ccRCC (17-50% in patients with prior cabozantinib exposure)
DCR: 80%–100% in ccRCC
Dose-escalation study ongoing and Phase 1b dose-expansion planned to assess optimal biologically active dose for combination

Tipifarnib + Alpelisib in PIK3CA-altered Head and Neck Squamous Cell Carcinoma – KURRENT-HN Phase 1 Trial

FTI mechanism blocks hyperactivated mTORC1 signaling in squamous tumor cells
Manageable safety profile in HNSCC patients across multiple doses
Robust antitumor activity was observed in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations
ORR: 47% was observed at a daily dose of tipifarnib 1200 mg + alpelisib 250 mg
Alpelisib monotherapy provides modest clinical benefit (ORR: 0%; BOR: SD)1 and tipifarnib monotherapy not expected to provide clinical benefit in this population
Data generation options for darlifarnib + PI3Kα inhibitor combinations in solid tumors are being assessed

"These results highlight the potential of FTIs to meaningfully enhance the clinical activity of PI3Kα inhibitors in molecularly selected patients," said Glenn Hanna, M.D., Director, Center for Cancer Therapeutic Innovation, Medical Oncologist, Center for Head & Neck Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School – an investigator on both the FIT-001 and KURRENT-HN trials. "Darlifarnib demonstrates robust activity in HRAS-mutant solid tumors, which are typically very challenging to treat using existing therapies. In addition, the combination of tipifarnib and alpelisib demonstrated robust antitumor activity in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations — a population where monotherapy alpelisib provides only modest clinical benefit. These combination data are very exciting and set the stage for combining darlifarnib with PI3Kα inhibitors."

Juric et al. J Clin Oncol 2018;36(13):1291-9.

Presentations
The presentations are available on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Farnesyl Transferase Inhibition section, and in the ESMO (Free ESMO Whitepaper) Congress 2025 online program.

Virtual Investor Event
Kura will host a webcast and conference call today, October 18, 2025, at 10:30 a.m. PT / 1:30 p.m. ET / 7:30 p.m. CEST featuring management and Glenn A. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation Medical Oncologist, Center for Head & Neck Oncology, Dana-Farber Cancer Institute and Associate Professor of Medicine, Harvard Medical School.

The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

(Press release, Kura Oncology, OCT 18, 2025, View Source [SID1234656745])