Kura Oncology Highlights Darlifarnib's Potential as a Foundational Combination Platform for KRAS-Mutant Cancers and Outlines Development Strategy

– Preliminary Phase 1a data from darlifarnib + adagrasib demonstrate confirmed, objective response rates of 67% in pancreatic cancer, 50% in non-small cell lung cancer, and 29% in KRAS inhibitor-naïve colorectal cancer patients –

– Clinical activity observed in both KRAS inhibitor-naïve and KRAS inhibitor-pretreated patients –

– Preclinical data support broad applicability across the evolving RAS inhibitor landscape, including mutant-selective, pan-KRAS and RAS(ON) multi-selective inhibitors –

– New platform study designed to accelerate evaluation of darlifarnib across multiple targeted therapies, combinations, and disease settings –

– First planned platform combination, darlifarnib + daraxonrasib in KRAS-mutant pancreatic cancer, expected to enter Phase 1a evaluation in early 2027 –

– Kura to host virtual investor event on June 3, 2026, at 12:15 p.m. PT / 3:15 p.m. ET to discuss darlifarnib data, platform strategy, and development plans –

SAN DIEGO, June 03, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, today highlighted new clinical and translational data supporting darlifarnib as a potential foundational combination platform for KRAS-mutant cancers and other targeted therapy settings. The data, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, support Kura's strategy to expand its next-generation farnesyl transferase inhibitor (FTI) through a new platform study designed to efficiently evaluate multiple combinations and identify opportunities to improve the depth and durability of responses to targeted therapies.

"Today's data release and strategic update reinforce our belief that darlifarnib represents much more than a single combination opportunity," said Troy E. Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With FTI clinical proof-of-concept now demonstrated in three distinct targeted therapy settings, and translational data supporting applicability across the evolving RAS inhibitor landscape, we believe darlifarnib has the potential to become a foundational combination backbone for molecularly defined cancers. Our planned platform study is designed to accelerate development across multiple combinations and disease settings, beginning with darlifarnib plus daraxonrasib in KRAS-mutant pancreatic cancer."

In preclinical models, translational data demonstrated that darlifarnib inhibits RHEB farnesylation and sustains suppression of mTORC1 signaling, a pathway implicated in adaptive resistance to KRAS inhibition. Preclinical studies further showed enhanced anti-tumor activity across multiple classes of RAS inhibitors, including mutant-selective and multi-selective RAS(ON) inhibitors, as well as pan-KRAS and pan-RAS approaches, and demonstrated tumor regressions in models previously exposed to KRAS inhibitor therapy.

FIT-001 ASCO Update

In the ongoing FIT-001 study, darlifarnib plus adagrasib demonstrated promising anti-tumor activity in heavily pretreated patients with KRAS G12C-mutated pancreatic ductal adenocarcinoma (PDAC), non-small cell lung (NSCLC), and colorectal (CRC) cancers. Among 26 response-evaluable patients, tumor shrinkage was observed in 77% of patients overall and in 94% of KRAS inhibitor-naïve patients. Confirmed objective response rates included 67% in PDAC, 50% in NSCLC, and 29% in KRAS inhibitor-naïve CRC. Clinical activity was also observed in patients previously treated with KRAS inhibitors.

Observed response rates compared favorably with historical adagrasib monotherapy benchmarks, supporting the hypothesis that darlifarnib may enhance the depth and durability of response when combined with KRAS-targeted therapies.

The ASCO findings represent the third clinical validation of Kura's FTI combination strategy, following previously reported activity in renal cell carcinoma and PIK3CA-mutated head and neck cancer.

Planned Platform Study

Kura believes the opportunity for darlifarnib extends beyond KRAS G12C. The Company plans to initiate a platform study designed to evaluate darlifarnib across multiple targeted therapy combinations and disease settings. The flexible design is intended to allow combinations with both approved and investigational targeted therapies, add new arms over time, and advance successful combinations into dedicated registrational studies.

Given the emerging clinical and translational data, Kura has seen growing interest in exploring darlifarnib across a variety of targeted therapy settings. The Company's planned platform study is designed to provide a flexible framework that could support evaluation of additional combination opportunities over time. The first planned combination in the new study will be darlifarnib plus daraxonrasib in 2L+ KRAS-mutant PDAC, which is expected to enter Phase 1a evaluation in early 2027.

"The KRAS treatment landscape is evolving rapidly, with multiple next-generation mutant-selective and pan-RAS approaches advancing through clinical development," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Our data suggest darlifarnib may have broad applicability across this expanding class of therapies, creating the opportunity to improve outcomes for patients while establishing a flexible platform for future development and collaboration."

Virtual Investor Event

Kura will host a webcast and conference call on June 3, 2026, at 12:15 p.m. PT / 3:15 p.m. ET featuring management and David S. Hong, M.D., Deputy Chair of the Department of Investigational Cancer Therapeutics, The University of Texas M.D. Anderson Cancer Center. 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.

About Kura Oncology

Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura's pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X 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, among other things, statements regarding darlifarnib's potential applicability across the RAS inhibitor landscape; darlifarnib's potential as a foundational combination platform for KRAS-mutant cancers and other targeted therapy settings; the conduct and timing of Kura's planned darlifarnib platform study and the potential of such study to accelerate darlifarnib's development across multiple combinations and disease settings; and the potential of darlifarnib to improve outcomes for patients. Factors that may cause actual results to differ materially include the risk that results observed in preclinical studies of darlifarnib or in the FIT-001 trial may not be predictive of results in later preclinical studies or clinical trials; the risk that Kura may not obtain access to daraxonrasib or to other compounds Kura seeks to evaluate in combination with darlifarnib; the risk that the FDA may not permit Kura's planned platform study to proceed on the anticipated timeline, or at all, and may require additional information, studies, analyses, or modifications to Kura's development plan, or may otherwise delay, restrict, or prevent the development, regulatory approval, or commercialization of darlifarnib; uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies; 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," "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 Kura faces, please refer to Kura'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. 

Kura Contact

Investors and Media:

Greg Mann

858-987-4046

gmann@kuraoncology.com