Our programs consist of small molecule drug candidates that target cancer signaling pathways, where each program builds on our expertise in precision medicines.

Program

Development Approach

Research

Dose Escalation

Dose Optimization

Registration-Enabling

Regulatory Submission

Clinical Trial

Menin Inhibitor

Ziftomenib**

Monotherapy

REGULATORY SUBMISSION

NPM1-mutant AML1

Monotherapy

DOSE ESCALATION

KMT2A-rearranged ALL

Monotherapy

DOSE OPTIMIZATION

Non-NPM1-mutant / Non-KMT2A-rearranged AML

Combinations with venetoclax/azacitidine, and cytarabine + daunorubicin (7+3)

DOSE OPTIMIZATION

NPM1-mutant AML

Combinations with venetoclax/azacitidine, and cytarabine + daunorubicin (7+3)

DOSE OPTIMIZATION

KMT2A-rearranged AML

Combinations with gilteritinib, FLAG-IDA, LDAC

DOSE ESCALATION

NPM1-mutant AML

Combinations with gilteritinib, FLAG-IDA, LDAC

DOSE ESCALATION

KMT2A-rearranged AML

Combination with imatinib

DOSE ESCALATION

Advanced gastrointestinal stromal tumors (GIST)

Combinations with venetoclax/azacitidine, cytarabine + daunorubicin (7+3)

REGISTRATION-ENABLING

NPM1-mutant AML2

Combinations with venetoclax/azacitidine, cytarabine + daunorubicin (7+3)

REGISTRATION-ENABLING

KMT2A-rearranged AML2

Ziftomenib

Ziftomenib is being investigated in up to 50% of AMLs, including NPM1-mutant AML and KMT2A-rearranged AML. It is also being investigated in combination with other cancer therapies.

**In Nov. 2024, Kura entered a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies.

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Farnesyl Transferase Inhibitors

Darlifarnib (KO-2806)

NEXT-GEN FTI

Monotherapy, combinations with cabozantinib and adagrasib

DOSE OPTIMIZATION

Solid tumors

Monotherapy, combinations with cabozantinib and adagrasib

DOSE ESCALATION

Renal cell carcinoma (RCC)

Monotherapy, combinations with cabozantinib and adagrasib

DOSE ESCALATION

KRASG12C-mutant non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Pancreatic ductal adenocarcinoma (PDAC)

Darlifarnib (KO-2806)

Darlifarnib (KO-2806) is an investigational potent next-generation FTI designed to potentially improve upon earlier FTI drug candidates. Darlifarnib is not FDA-approved and safety and efficacy have not been established.

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Farnesyl Transferase Inhibitors

Tipifarnib

Combination with alpelisib

REGISTRATION-ENABLING

PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC)3

Tipifarnib

Tipifarnib is an oral investigational FTI that is not FDA-approved. Safety and efficacy have not been established.

View publications and presentations

Next-Gen Menin Inhibitor

RESEARCH

Diabetes

The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.

FLAG-IDA: fludarabine, high-dose cytarabine (Ara-C), granulocyte-colony stimulating factor (G-CSF) and idarubicin; LDAC: Low-dose cytarabine

XOSPATA® (gilteritinib); PIQRAY® (alpelisib)

1 NDA accepted for filing with PDUFA date of November 30, 2025.
2 KOMET-017 program to advance directly to Registration-Enabling trials, leveraging data from Phase 1 combination trials.
3 Enrollment is complete.