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Kura Oncology

Kura Oncology logo
🇺🇸United States
Ownership
Public
Established
2014-01-01
Employees
142
Market Cap
$1.5B
Website
http://www.kuraoncology.com
Introduction

Kura Oncology, Inc. operates as a clinical-stage biopharmaceutical company, which engages in the research and development of medicines for the treatment of cancer. Its pipeline includes Tipifarnib, which is a Farnesyl transferase inhibitor for HRAS Mutant Solid Tumors, Chronic Myelomonocytic Leukemia, KO-947, which is an ERK inhibitor for MAPK Pathway Tumors, and KO-539, which is a Menin MLL inhibitor for acute leukemias. The company was founded by Troy E. Wilson, Yi Liu, Pingda Ren and Antonio Gualberto on August 22, 2014 and is headquartered in San Diego, CA.

Clinical Trials

35

Active:17
Completed:6

Trial Phases

3 Phases

Phase 1:25
Phase 2:7
Phase 3:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (33 trials with phase data)• Click on a phase to view related trials

Phase 1
25 (75.8%)
Phase 2
7 (21.2%)
Phase 3
1 (3.0%)

Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

Phase 3
Not yet recruiting
Conditions
Acute Myeloid Leukemia (AML)
Interventions
First Posted Date
2025-06-05
Last Posted Date
2025-06-05
Lead Sponsor
Kura Oncology, Inc.
Target Recruit Count
1300
Registration Number
NCT07007312

A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Phase 1
Recruiting
Conditions
Gastrointestinal Stromal Tumor (GIST)
Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract
Gastrointestinal Stromal Cancer
Gastrointestinal Stromal Neoplasm
Gastrointestinal Stromal Tumor, Malignant
Gastrointestinal Stromal Cell Tumors
Interventions
First Posted Date
2024-10-23
Last Posted Date
2025-07-28
Lead Sponsor
Kura Oncology, Inc.
Target Recruit Count
157
Registration Number
NCT06655246
Locations
🇺🇸

University of Southern California, Los Angeles, California, United States

🇺🇸

Yale University School of Medicine, New Haven, Connecticut, United States

🇺🇸

University of Iowa, Iowa City, Iowa, United States

and more 7 locations

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Phase 1
Recruiting
Conditions
Solid Tumors With HRAS Alterations
Non Small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Pancreatic Ductal Adenocarcinoma (PDAC)
Clear Cell Renal Cell Carcinoma (ccRCC)
Renal Cell Carcinoma (Kidney Cancer)
Interventions
First Posted Date
2023-09-07
Last Posted Date
2025-06-13
Lead Sponsor
Kura Oncology, Inc.
Target Recruit Count
270
Registration Number
NCT06026410
Locations
🇺🇸

Henry Ford Health System, Detroit, Michigan, United States

🇺🇸

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

🇺🇸

UT Southwestern Simmons Cancer Center, Dallas, Texas, United States

and more 23 locations

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase 1
Recruiting
Conditions
AML
AML With Mutated NPM1
Hematologic Malignancy
KMT2Ar
NPM1 Mutation
MLL Rearrangement
Leukemia
Acute Myeloid Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Interventions
First Posted Date
2023-08-21
Last Posted Date
2025-07-16
Lead Sponsor
Kura Oncology Inc.
Target Recruit Count
30
Registration Number
2023-510288-37-00
Locations
🇺🇸

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

🇺🇸

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

UCLA Health - Bowyer Oncology Center, Los Angeles, California, United States

and more 38 locations

Expanded Access to Ziftomenib

Conditions
Acute Lymphoblastic Leukemia, With Appropriate Mutations
Acute Myeloid Leukemia, With NPM1 Mutations
First Posted Date
2023-02-22
Last Posted Date
2025-06-04
Lead Sponsor
Kura Oncology, Inc.
Registration Number
NCT05738538
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News

Kura Oncology's Ziftomenib Receives FDA Priority Review for NPM1-Mutant AML, PDUFA Date Set for November 2025

Kura Oncology's lead asset ziftomenib has advanced to FDA Priority Review for relapsed/refractory NPM1-mutant acute myeloid leukemia, with a PDUFA date of November 30, 2025.

Day One Biopharmaceuticals Appoints Michael Vasconcelles as Head of R&D to Drive Pipeline Expansion

Day One Biopharmaceuticals has appointed Michael Vasconcelles, M.D., as Head of Research and Development, bringing over 25 years of oncology research and development expertise to the company.

FDA Accepts Kura Oncology's NDA for Ziftomenib in NPM1-Mutant AML with Priority Review

The FDA has accepted Kura Oncology's new drug application for ziftomenib, an oral menin inhibitor for treating relapsed or refractory acute myeloid leukemia with NPM1 mutations.

Pharmaceutical Industry Sees Wave of Board Appointments as Companies Strengthen Leadership

Pharmaceutical and biotech companies across Europe and North America have made significant board appointments, bringing industry veterans and scientific experts to strengthen their leadership teams.

Kura Oncology Initiates Phase 1 Trial Combining Ziftomenib with Imatinib for Advanced GIST Treatment

Kura Oncology has dosed first patients in KOMET-015, a Phase 1 trial evaluating ziftomenib in combination with imatinib for advanced gastrointestinal stromal tumors (GIST) after imatinib failure.

Kura Oncology's KO-2806 Shows Promise in Combination Therapy for Renal Cell Carcinoma

Preclinical data for Kura Oncology's next-generation farnesyl transferase inhibitor KO-2806 in combination with cabozantinib has been selected for oral presentation at the 2025 AACR Annual Meeting.

Over 120 Pipeline Therapies Target Acute Myeloid Leukemia as Research Intensifies

• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.

Kura Oncology and Kyowa Kirin's Ziftomenib Achieves Primary Endpoints in Phase II AML Trial

Ziftomenib, a selective oral menin inhibitor developed by Kura Oncology and Kyowa Kirin, has successfully met primary endpoints in the Phase II Komet-001 registrational trial for acute myeloid leukemia.

Kura Oncology's Menin Inhibitor Ziftomenib Shows Promise in Mid-Stage Cancer Trial

Kura Oncology and Kyowa Kirin report positive results from their Phase 2 clinical trial evaluating ziftomenib, a novel menin inhibitor for cancer treatment.

Ziftomenib Achieves Primary Endpoint in Pivotal AML Trial, Kura and Kyowa Kirin Prepare FDA Filing

Kura Oncology and Kyowa Kirin's oral menin inhibitor ziftomenib met its primary endpoint in the KOMET-001 trial for NPM1-mutated relapsed/refractory acute myeloid leukemia patients.

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