Pipeline v3 | Kura Oncology

Our programs comprise of small molecule drug candidates that target cancer signaling pathways, where each program builds on our expertise in precision medicines and seeks to drive better outcomes for patients and broaden the eligible patient population through rational combinations.

Candidate

Development Approach

Planned

Study Startup

Phase 1

Registration Directed

Trial

Menin Inhibitor

Ziftomenib

Monotherapy

Phase 1

NPM1-mutant acute myeloid leukemia (AML)

Monotherapy

Study Startup

Non-NPM1-m / Non-KMT2A-r AML

Monotherapy

Study Startup

KMT2A-rearranged ALL

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

Study Startup

NPM1-mutant AML

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

Study Startup

KMT2A-rearranged AML

Combinations with gilteritinib, FLAG-IDA, LDAC

Study Startup

NPM1-mutant AML

Combinations with gilteritinib, FLAG-IDA, LDAC

Study Startup

KMT2A-rearranged AML

Post-Transplant Maintenance

Study Startup

NPM1-mutant AML

Investigator-sponsored studies

Post-Transplant Maintenance

Study Startup

KMT2A-rearranged AML

Investigator-sponsored studies

Combination with FLA

Study Startup

Pediatric AML & ALL

Investigator-sponsored studies

Combination with BV-DAM

Study Startup

Pediatric ALL

Investigator-sponsored studies

Ziftomenib

Ziftomenib is an investigational drug candidate and oral inhibitor of menin-KMT2A (MLL) for the treatment of Acute Myeloid Leukemia (AML), with the potential to combine with other targeted therapies. Ziftomenib is currently currently being evaluated in the KOMET-001 Trial.

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Farnesyl Transferase Inhibitors (FTI)

Tipifarnib

Combination with alpelisib

Phase 1

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

Tipifarnib

Tipifarnib is an oral, investigational drug candidate and highly selective inhibitor of farnesyltransferase. Farnesyl transferase inhibitors (FTI) – such as tipifarnib – have multiple potential therapeutic applications, including direct inhibition of oncogenic proteins; overcoming drug resistance; and preventing emergence of resistance. Tipifarnib is currently being evaluated in patients with PIK3CA-dependent HNSCC (enrollment ongoing in KURRENT-HN Trial).

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Farnesyl Transferase Inhibitors

KO-2806

Next-Generation FTI

Combinations with targeted therapies

Study Startup

Clear Cell Renal Cell Carcinoma

Combinations with targeted therapies

Study Startup

Non-Small Cell
Lung Cancer

Combinations with targeted therapies

Study Startup

Other Solid tumors

KO-2806

KO-2806 is a potent next-generation FTI designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates and address large oncology indications of high unmet need through rational combinations. Preclinical data is supportive of FTIs in combination with other targeted therapies to potentially overcome or prevent emergence of drug resistance to certain classes of drugs. The FDA has cleared the IND application for KO-2806 and Kura intends to evaluate KO-2806 for the treatment of advanced solid tumors (FIT-001 Trial).

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

FLA: fludarabine and high dose cytarabine; BV-DAM: bortezomib, vorinostat, dexamethasone, PEG-asparaginase and mitoxantrone

XOSPATA® (gilteritinib); PIQRAY® (alpelisib)