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Kura Oncology Announces Preclinical Data for KO-2806 Selected for Oral Presentation at the 2025 AACR Annual Meeting

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Kura Oncology (NASDAQ: KURA) announced that preclinical data for its next-generation farnesyl transferase inhibitor (FTI) KO-2806 has been selected for oral presentation at the 2025 AACR Annual Meeting in Chicago.

The presentation will focus on KO-2806's combination with cabozantinib, a tyrosine kinase inhibitor (TKI), in clear cell renal cell carcinoma (ccRCC). The oral presentation, titled 'Farnesyl transferase inhibitor KO-2806 enhances the antitumor activity of cabozantinib in ccRCC tumors that progress on anti-VEGFR agents,' is scheduled for April 28, 2025.

The company expects to present data from the Phase 1 FIT-001 trial evaluating KO-2806 both as monotherapy and in combination with cabozantinib for RCC treatment in the second half of 2025.

Kura Oncology (NASDAQ: KURA) ha annunciato che i dati preclinici per il suo inibitore della farnesil transferasi di nuova generazione (FTI) KO-2806 sono stati selezionati per una presentazione orale al Meeting Annuale AACR 2025 a Chicago.

La presentazione si concentrerà sulla combinazione di KO-2806 con cabozantinib, un inibitore della tirosina chinasi (TKI), nel carcinoma renale a cellule chiare (ccRCC). La presentazione orale, intitolata 'L'inibitore della farnesil transferasi KO-2806 potenzia l'attività antitumorale di cabozantinib nei tumori ccRCC che progrediscono con agenti anti-VEGFR,' è programmata per il 28 aprile 2025.

L'azienda prevede di presentare dati dal trial di Fase 1 FIT-001 che valuta KO-2806 sia come monoterapia che in combinazione con cabozantinib per il trattamento del RCC nella seconda metà del 2025.

Kura Oncology (NASDAQ: KURA) anunció que los datos preclínicos para su inhibidor de farnesil transferasa de nueva generación (FTI) KO-2806 han sido seleccionados para una presentación oral en la Reunión Anual AACR 2025 en Chicago.

La presentación se centrará en la combinación de KO-2806 con cabozantinib, un inhibidor de la tirosina quinasa (TKI), en el carcinoma de células renales de células claras (ccRCC). La presentación oral, titulada 'El inhibidor de farnesil transferasa KO-2806 potencia la actividad antitumoral de cabozantinib en tumores ccRCC que progresan con agentes anti-VEGFR,' está programada para el 28 de abril de 2025.

La empresa espera presentar datos del ensayo de Fase 1 FIT-001 que evalúa KO-2806 tanto como monoterapia como en combinación con cabozantinib para el tratamiento del RCC en la segunda mitad de 2025.

Kura Oncology (NASDAQ: KURA)는 차세대 파르네실 전이효소 억제제(FTI) KO-2806의 전임상 데이터가 2025년 AACR 연례 회의에서 구두 발표로 선정되었다고 발표했습니다.

이번 발표는 명확한 세포 신장 세포 암종(ccRCC)에서 KO-2806과 티로신 키나제 억제제(TKI)인 카보잔티닙의 조합에 초점을 맞출 것입니다. '파르네실 전이효소 억제제 KO-2806은 항-VEGFR 약물에 반응하지 않는 ccRCC 종양에서 카보잔티닙의 항종양 활성을 향상시킨다'는 제목의 구두 발표는 2025년 4월 28일로 예정되어 있습니다.

회사는 2025년 하반기에 RCC 치료를 위해 KO-2806을 단독 요법 및 카보잔티닙과의 조합으로 평가하는 1상 FIT-001 시험의 데이터를 발표할 계획입니다.

Kura Oncology (NASDAQ: KURA) a annoncé que des données précliniques pour son inhibiteur de la farnésyl transférase de nouvelle génération (FTI) KO-2806 ont été sélectionnées pour une présentation orale lors de la Réunion Annuelle AACR 2025 à Chicago.

La présentation se concentrera sur la combinaison de KO-2806 avec le cabozantinib, un inhibiteur de la tyrosine kinase (TKI), dans le carcinome rénal à cellules claires (ccRCC). La présentation orale, intitulée 'L'inhibiteur de la farnésyl transférase KO-2806 renforce l'activité antitumorale du cabozantinib dans les tumeurs ccRCC qui progressent sous les agents anti-VEGFR,' est prévue pour le 28 avril 2025.

L'entreprise prévoit de présenter des données de l'essai de Phase 1 FIT-001 évaluant KO-2806 à la fois en monothérapie et en combinaison avec le cabozantinib pour le traitement du RCC dans la seconde moitié de 2025.

Kura Oncology (NASDAQ: KURA) gab bekannt, dass präklinische Daten für seinen Next-Generation Farnesyltransferase-Inhibitor (FTI) KO-2806 für eine mündliche Präsentation auf dem AACR-Jahrestreffen 2025 in Chicago ausgewählt wurden.

Die Präsentation wird sich auf die Kombination von KO-2806 mit Cabozantinib, einem Tyrosinkinase-Inhibitor (TKI), beim klarzelligen Nierenzellkarzinom (ccRCC) konzentrieren. Die mündliche Präsentation mit dem Titel 'Farnesyltransferase-Inhibitor KO-2806 verstärkt die antitumorale Aktivität von Cabozantinib in ccRCC-Tumoren, die auf anti-VEGFR-Agentien fortschreiten,' ist für den 28. April 2025 geplant.

Das Unternehmen plant, in der zweiten Hälfte des Jahres 2025 Daten aus der Phase-1-Studie FIT-001 zu präsentieren, die KO-2806 sowohl als Monotherapie als auch in Kombination mit Cabozantinib zur Behandlung von RCC bewertet.

Positive
  • Preclinical data shows KO-2806's potential to enhance antitumor activities when combined with existing treatments
  • Phase 1 trial FIT-001 is progressing well with data expected in H2 2025
  • Selection for oral presentation at major cancer research conference (AACR) indicates scientific significance
Negative
  • Drug is still in early development phase (preclinical/Phase 1)
  • Clinical efficacy in humans yet to be demonstrated

– Oral presentation to highlight preclinical data further supporting combination of KO-2806 with TKIs in ccRCC –

– Company expects to present data from the Phase 1 FIT-001 trial evaluating KO-2806 and cabozantinib in patients with RCC in 2H 2025 –

SAN DIEGO, March 26, 2025 (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 announced that an abstract containing preclinical data for KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI), in combination with cabozantinib, a tyrosine kinase inhibitor (TKI), in clear cell renal cell carcinoma (ccRCC), has been accepted for an oral presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL on April 29, 2025.

“The latest findings for our next-generation farnesyl transferase inhibitor, KO-2806, being presented at this year’s AACR Annual Meeting, add to the growing body of data demonstrating the potential of FTIs as companion therapeutic agents to augment the antitumor activities of various targeted therapies and to overcome resistance in combination,” said Francis Burrows, Ph.D., Chief Scientific Officer of Kura Oncology. “We continue to make good progress in our FIT-001 trial evaluating KO-2806 in solid tumor indications where there is unmet medical need, and we look forward to presenting the first clinical data for KO-2806 as monotherapy and in combination with cabozantinib for the treatment of RCC later this year.”

The title and session information for the oral presentation are listed below. Full abstract details including title and text are currently available to registrants via the AACR online itinerary planner. Details of the oral presentation, entitled “Farnesyl transferase inhibitor KO-2806 enhances the antitumor activity of cabozantinib in ccRCC tumors that progress on anti-VEGFR agents” (oral 6370), are as follows:

Session Date and Time: Monday, April 28, 2025; 2:30 PM - 4:45 PM CT
Session Title: Minisymposium Novel Antitumor Agents
Presentation Time: 4:25 PM - 4:40 PM CT       

A copy of the presentation will be available in the Posters and Presentations section on Kura’s website at the beginning of the presentation session.                

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 targeting cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and the companies anticipate submission of a New Drug Application (NDA) to the FDA in the second quarter of 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent HNSCC.  For additional information, please visit Kura’s website at www.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 statements regarding, among other things, the potential of FTIs to augment the antitumor activities of targeted therapies and to overcome resistance; the progress of Kura’s clinical trials; the efficacy, safety and therapeutic potential of Kura’s product candidates, ziftomenib, KO-2806 and tipifarnib; the expected timing and presentation of results and data from clinical trials; and the anticipated timing of submission of an NDA for ziftomenib. 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:
Patti Bank
Managing Director
(415) 513-1284
patti.bank@icrhealthcare.com

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


FAQ

What is the significance of KO-2806's AACR presentation for Kura Oncology (KURA)?

The presentation demonstrates KO-2806's potential as a companion therapeutic agent to enhance antitumor activities and overcome resistance when combined with targeted therapies like cabozantinib in ccRCC treatment.

When will Kura Oncology (KURA) present clinical trial data for KO-2806?

Kura Oncology will present data from the Phase 1 FIT-001 trial of KO-2806 in the second half of 2025.

What type of cancer is KURA's KO-2806 targeting in the presented study?

KO-2806 is targeting clear cell renal cell carcinoma (ccRCC) in combination with cabozantinib.

When and where will KURA present the KO-2806 preclinical data at AACR 2025?

The presentation will take place on April 28, 2025, from 4:25 PM to 4:40 PM CT at the AACR Annual Meeting in Chicago.
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