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
17 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2014
Active, not recruiting
17
48.6%
Available
2
5.7%
Completed
7
20.0%
Recruiting
5
14.3%
Terminated
3
8.6%
Withdrawn
1
2.9%
No approval data available
- Royalty Pharma has donated $7.5 million to Blood Cancer United's Therapy Acceleration Program, becoming the first and largest corporate donor under an updated funding model. - TAP deploys donations as venture capital investments in early-stage biotech companies, reinvesting financial returns to fund future blood cancer therapy development. - The program has supported six therapies that reached FDA approval or National Comprehensive Cancer Network guidelines, with more than 30 active clinical studies underway. - Blood Cancer UK contributed $1 million and Blood Cancer United committed $15 million as inaugural funders of TAP's next phase.
- Kura Oncology launched Caspian Therapeutics with $50 million in financing to develop small-molecule menin inhibitors for diabetes and other cardiometabolic diseases. - The lead candidate KO-7246 is expected to enter a Phase 1 clinical trial in diabetes by the end of next year, with data anticipated in 2028. - Menin inhibition may selectively expand pancreatic β islet cell mass and increase insulin production, an approach Kura CEO Troy Wilson calls a "unicorn" target. - Backers include BVF Partners, Eli Lilly, the T1D Fund, and prior Kura investors, with Kura retaining roughly 50% ownership of the new company.
- Kura Oncology's menin inhibitor ziftomenib (Komzifti) received FDA approval in November 2025 for AML patients with NPM1 mutations or KMT2A rearrangements. - The San Diego-based biotech, founded in 2014, is now pursuing broader AML indications for ziftomenib to address this notoriously difficult-to-treat cancer. - Kura is also advancing darlifarnib, a farnesyl transferase inhibitor, which the company believes could complement Revolution Medicines' breakthrough RAS inhibitor daraxonrasib. - CEO Troy Wilson previously co-founded three companies — Intellikine, Ambrx, and Avidity Biosciences — all of which were successfully acquired.
- Kura Oncology will present updated data from the FIT-001 clinical trial evaluating darlifarnib plus cabozantinib in advanced clear cell renal cell carcinoma patients at IKCS Europe 2026. - The combination demonstrated encouraging clinical activity and manageable safety profile in earlier findings presented at ESMO 2025 Congress. - Darlifarnib is designed to overcome resistance and resensitize tumors to VEGFR TKI therapy through its mechanism of inhibiting farnesylation of RHEB and suppressing mTORC1 signaling. - The presentation will focus on preliminary Phase 1 results in patients who previously received cabozantinib treatment, supporting the potential to enhance targeted therapy activity.
- DelveInsight's analysis reveals a robust acute myeloid leukemia pipeline with over 100 companies actively developing 150+ therapeutic candidates across various clinical stages. - Recent regulatory milestones include FDA approval of KOMZIFTI (ziftomenib) for relapsed/refractory NPM1-mutated AML and priority review acceptance for revumenib, both representing first-in-class menin inhibitors. - The pipeline features diverse therapeutic approaches including targeted therapies like isocitrate dehydrogenase inhibitors, immunotherapies, and novel mechanisms of action addressing unmet medical needs in this aggressive blood cancer.
- Kura Oncology completed the first U.S. commercial sale of KOMZIFTI (ziftomenib), triggering a $135 million milestone payment from partner Kyowa Kirin expected before year-end. - KOMZIFTI is an FDA-approved once-daily oral menin inhibitor for treating adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, approved on November 13, 2025. - The milestone payment represents a significant commercial achievement under Kura's collaboration and license agreement with Kyowa Kirin for the precision oncology treatment. - This commercial launch marks Kura's transition from development to commercialization of its lead precision medicine targeting cancer signaling pathways in hematologic malignancies.
- The FDA approved Kura Oncology's once-daily pill Komzifti (ziftomenib) for treating relapsed/refractory acute myeloid leukemia with NPM1 mutations, affecting about 30% of AML cases. - Komzifti gains a competitive safety edge over Syndax's recently approved Revuforj by avoiding a boxed warning for cardiac side effects, carrying only a regular warning for QTc prolongation. - The drug will be priced at $48,500 for a one-month supply and is expected to generate $1.32 billion in annual sales by 2031 according to analyst projections.
- The FDA is set to make five significant regulatory decisions in November 2025, including approvals for treatments targeting rare genetic disorders, multiple cancer types, and kidney disease. - Arrowhead Pharmaceuticals' plozasiran for familial chylomicronemia syndrome demonstrated an 80% median reduction in triglyceride levels and 83% lower risk of acute pancreatitis in Phase III trials. - Bayer's sevabertinib showed promising efficacy in HER2-mutant non-small cell lung cancer with overall response rates ranging from 38% to 71% depending on prior treatment history. - Multiple bispecific antibodies and targeted therapies are seeking expanded indications, potentially reshaping treatment landscapes in oncology and rare diseases.
- Kura Oncology presented preclinical data demonstrating KO-2806's potential to overcome drug resistance when combined with PI3Kα inhibitors, KRAS inhibitors, and antiangiogenic TKIs across multiple tumor types. - The company's next-generation farnesyl transferase inhibitor showed ability to re-sensitize tumors to KRAS inhibitors in preclinical NSCLC and colorectal cancer models of relapsed settings. - KO-2806 combinations could potentially address more than 200,000 incident patients annually in the U.S., with clinical data to be presented at ESMO Congress 2025 in October. - Three Phase 1 clinical trials are ongoing, including combination studies with cabozantinib in renal cell carcinoma and monotherapy evaluation in advanced solid tumors.
- UK-based Charm Therapeutics secured $80 million in Series B funding to advance its next-generation menin inhibitor for acute myeloid leukemia into Phase I clinical trials starting Q1 2026. - The company's AI-driven DragonFold platform designed a menin inhibitor that maintains potency against all known clinical resistance mutations, addressing key limitations of first-generation therapies. - The funding round was co-led by New Enterprise Associates and SR One, with participation from NVIDIA, OrbiMed, F-Prime, and Khosla Ventures. - Charm's candidate is designed to be efficacious at low doses while avoiding cardiac arrhythmia and drug-drug interactions associated with existing menin inhibitors.
