KURA
Published on 04/17/2026 at 12:00 pm EDT
Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer
April 17, 2026
PARTICIPANTS
Troy Wilson, Ph.D., J.D.
President & Chief Executive Officer
Kura Oncology
Adanma Ayanambakkam, M.D., M.S.
Assistant Professor, Hematology Oncology, and Medical Director, Genitourinary Medical Oncology Research, Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Mollie Leoni, M.D.
Chief Medical Officer Kura Oncology
3
KURA ONCOLOGY
Commercial-stage precision oncology company
KOMZIFTI (ziftomenib) approved for treatment of adult patients with relapsed/refractory NPM1-mutated acute myeloid leukemia (AML)
Developing ziftomenib as a treatment to address up to 50% of AML patients
Cancer is best treated via combinations1: our novel agents are designed to overcome treatment gaps and improve patient outcomes
Deep pipeline of potentially transformative therapies, positioning company for long-term, sustainable growth
NASDAQ: KURA
Gilad Y, Gellerman G, Lonard DM, O'Malley BW. Drug Combination in Cancer Treatment-From Cocktails to 4
Conjugated Combinations. Cancers (Basel). 2021 Feb 7;13(4):669.
PRECISION COMBINATIONS. BETTER PATIENT OUTCOMES.
5
OUR GOAL: DEVELOP PRECISION COMBINATIONS TO IMPROVE OUTCOMES FOR PEOPLE WITH CANCER
Ziftomenib combinations in AML
Intensive chemotherapy (cytarabine and daunorubicin)
Non-intensive chemotherapy (venetoclax and azacitidine)
FLT3 inhibitors (gilteritinib and quizartinib)
Ziftomenib combinations in gastrointestinal stromal tumors (GIST)
KIT inhibitors (imatinib)
Darlifarnib combinations in kidney cancer (renal cell carcinomas or RCC)
Anti-VEGFR inhibitors (cabozantinib)
Darlifarnib combinations in KRAS-mutated lung, colorectal and pancreatic cancers
KRAS G12C inhibitors (adagrasib)
OUR GOAL: DEVELOP PRECISION COMBINATIONS TO IMPROVE OUTCOMES FOR PEOPLE WITH CANCER
Ziftomenib combinations in AML
Intensive chemotherapy (cytarabine and daunorubicin)
Non-intensive chemotherapy (venetoclax and azacitidine)
FLT3 inhibitors (gilteritinib and quizartinib)
Ziftomenib combinations in gastrointestinal stromal tumors (GIST)
KIT inhibitors (imatinib)
Darlifarnib combinations in kidney cancer (renal cell carcinomas or RCC)
Anti-VEGFR inhibitors (cabozantinib)
Darlifarnib combinations in KRAS-mutated lung, colorectal and pancreatic cancers
KRAS G12C inhibitors (adagrasib)
3L+
Belzutifan
Lenvatinib
2L+
Sorafenib
Everolimus
Axitinib
Nivolumab
Lenvatinib + Everolimus
Cabozantinib
HIF-2α inhibitors + TKI Combo(s)
2023
1L
Ipilimumab
Nivolumab +
Temsirolimus
IL-2
Sunitinib
Pazopanib
Axitinib +
Pembrolizumab
Interferon-α
Bevacizumab
+Atezolizumab
2026+
2021
2019
2018
2016
2015
2012
2009
2007
2006
2005
1992
1989
Bevacizumab
+ Interferon-α
Cabozantinib + Nivolumab
envatinib + brolizumab
L
Pem
Axitinib + Avelumab
Next-generation farnesyl transferase inhibitor (FTI) optimized for precision combinations.
Cabozantinib, axitinib, lenvatinib, and other TKI therapies block VEGFR and other kinases that drive tumor growth.
The anti-VEGFR therapies act to prevent tumor growth and the formation of new blood vessels that support the tumor.
These anti-VEGFR therapies are an important component of every line of therapy for kidney cancer.
However, when a patient's disease progresses on anti-VEGFR therapy, subsequent therapies are less effective -highlighting the need for new approaches including new precision combinations.
ORR with subsequent treatment after prior cabozantinib or other TKI exposure ~17% - 22%1-3
VEGF, vascular endothelial growth factor receptor
Choueiri TK et al. Lancet Oncol. 2016;17:917-927; 2. Choueiri TK et al. N. Engl. J. Med. 2024;391:710-
Adapted from Choueiri et al. N. Engl. J. Med. 2017;376:354-366
Darlifarnib blocks farnesylation of RHEB, a protein essential to activation of mTORC1.
This provides a second, complementary block on the key pathways in kidney cancer tumor cells.
Preclinical studies show darlifarnib can block tumor growth and
inhibit angiogenesis.
Because darlifarnib only blocks mTORC1, one component of the TOR complex, it appears to have a superior safety and tolerability profile relative to first-generation mTOR inhibitors.
Together with cabozantinib, the precision combination with darlifarnib may improve activity and overcome resistance to prior cabozantinib.
Darlifarnib
Smith et al. Cancer Res. 2023;83(19):3252-63;
Patel, HV, Smith, AE et al. bioRxiv 2024;12(20):629824
Darlifarnib blocks farnesylation of RHEB, a protein essential to activation of mTORC1.
This provides a second, complementary block on the key pathways in kidney cancer tumor cells.
Preclinical studies show darlifarnib can block tumor growth and
inhibit angiogenesis.
Because darlifarnib only blocks mTORC1, one component of the TOR complex, it appears to have a superior safety and tolerability profile relative to first-generation mTOR inhibitors.
Together with cabozantinib, the precision combination with darlifarnib may improve activity and overcome resistance to prior cabozantinib.
Darlifarnib
Smith et al. Cancer Res. 2023;83(19):3252-63;
Patel, HV, Smith, AE et al. bioRxiv 2024;12(20):629824
Farnesyl transferase inhibitor (FTI) darlifarnib (KO-2806) combined with cabozantinib (cabo) in clear cell renal cell carcinoma (ccRCC) patients after prior exposure to cabo: Preliminary phase 1 results from FIT-001
Yousef Zakharia1, Adam E. Singer2, Benjamin Garmezy3, Jacob Thomas4, Douglas E. Laux5, Jason Henry6, Liza Villaruz7, Sanjay Goel8, Paria Mahboub Johnson9, Jenchun Kuan10, Binaifer Balsara9, Mollie Leoni9, Adanma Ayanambakkam11
1Mayo Clinic Comprehensive Cancer Center, Phoenix, AZ, USA; 2Division
of Hematology-Oncology, University of California Los Angeles Medical Center, Los Angeles, CA, USA; 3Sarah Cannon Research Institute, Nashville, TN, USA; 4Division of Medical Oncology, Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA; 5Division of Hematology, Oncology and Blood & Marrow Transplantation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA; 6Sarah Cannon Research Institute at Health One, Denver, CO, USA; 7UPMC Hillman Cancer Center, Pittsburgh, PA, USA;
8Rutgers Cancer Institute of New Jersey, Brunswick, NJ, USA; 9Clinical Development, Kura Oncology, Inc., San Diego, CA, USA; 10Biometrics, Kura Oncology, Inc., San Diego, CA, USA; 11Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA
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Dr. A
Dr. Ayanambakkam's disclosures include consulting or advisory roles with Regeneron, Pfizer Oncology, Astellas Pharma, Bristol Myer Squibb - WINN CDA, Pharmacosmos Therapeutics, Natera Oncology, Foundation Medicine, National Cancer Institute, Native American Center of Cancer Health Excellence, AVEO, Johnson & Johnson, Kura Oncology.
First-in-human, multicenter, open-label, phase 1a/b dose-escalation/-expansion study of
darlifarnib alone and in combination in patients with advanced solid tumors
Darlifarnib 3 mg
Darlifarnib 3 mg
Cabo 40 mg
+
Darlifarnib 5 mg
Darlifarnib 5 mg
Darlifarnib
Combination Phase 1b: Dose Expansiona
Darlifarnib 8 mg
Darlifarnib 8 mg
Darlifarnib 3 mg
Darlifarnib 10 mg
Cabo 60 mg
+
Darlifarnib 5 mg
Darlifarnib 15 mgb
Darlifarnib 8 mg
Darlifarnib + cabozantinib combination for patients with ccRCC or non-ccRCC
Darlifarnib 3, 5, or 8 mg was administered QD orally Days 1-7 and 15-21 plus continuous
cabozantinib 40 mg or 60 mg QD in 28-day cycles
Darlifarnib + Cabozantinib
(Phase 1a: Dose Escalation)a,c
Darlifarnib Monotherapy
(Phase 1a: Dose Escalation)a
a Each individual patient will receive one of the planned DLs of darlifarnib. b Non-tolerated DL. c n=12 patients per dose level. d Up to 2 potential darlifarnib RP2Ds may be further evaluated in phase 1b dose expansion in combination with cabo.
cc, clear cell; DL, dose level; IO, immune checkpoint inhibition; QD, once daily; RCC, renal cell carcinoma.
n (%)
Cabozantinib 40 mg
Cabozantinib 60 mga
Total N=18
Darlifarnib 3 mg
n=6
Darlifarnib 5 mg
n=6
Darlifarnib 8 mg
n=3
Darlifarnib 3 mg
n=3
Median age, years (range)
63 (54-82)
66 (54-79)
56 (48-80)
70 (66-79)
67 (48-82)
Male
3 (50)
4 (67)
3 (100)
2 (67)
12 (67)
Race
White
4 (67)
3 (50)
2 (67)
3 (100)
12 (67)
Karnofsky PS
50-70
0
0
0
0
0
80-100
6 (100)
6 (100)
3 (100)
3 (100)
18 (100)
Distant metastasis
6 (100)
6 (100)
3 (100)
2 (67)
17 (94)
Prior lines
1
1 (17)
1 (17)
1 (33)
0
3 (17)
2
2 (33)
2 (33)
0
2 (67)
6 (33)
≥3
3 (50)
3 (50)
2 (67)
1 (33)
9 (50)
Prior therapy type(s)
Cabo (immediate prior line)
3 (50)
3 (50)
2 (67)
2 (67)
10 (56)
Other TKI (any prior line)
3 (50)
4 (67)
2 (67)
3 (100)
12 (67)
All patients received prior I/O-based treatment as well as prior cabozantinib
More than half of patients (56%) received prior cabozantinib as immediate prior line
Most patients (67%) had exposure to other TKIs, including axitinib, lenvatinib, sunitinib, tivozanib,
n (%)
Cabozantinib 40 mg
Cabozantinib 60 mg
Darlifarnib 3 mg n=11
Darlifarnib 5 mg n=12
Darlifarnib 8 mg n=12
Darlifarnib 3 mg n=11
Darlifarnib 5 mg n=12
Darlifarnib 8 mg n=12
Any-grade darlifarnib TRAEs
9 (82)
11 (92)
10 (83)
7 (64)
10 (83)
11 (92)
Neutropenia
1 (9)
5 (42)
8 (67)
2 (18)
6 (50)
7 (58)
Fatigue
4 (36)
2 (17)
6 (50)
3 (27)
2 (17)
4 (33)
Diarrhea
4 (36)
3 (25)
2 (17)
3 (27)
4 (33)
2 (17)
Nausea
4 (36)
4 (33)
1 (8)
1 (9)
4 (33)
4 (33)
Thrombocytopenia
1 (9)
3 (25)
3 (25)
2 (18)
3 (25)
3 (25)
Grade ≥3 darlifarnib TRAEs
4 (36)
7 (58)
8 (67)
2 (18)
7 (58)
7 (58)
Neutropenia
1 (9)
5 (42)
7 (58)
1 (9)
4 (33)
3 (25)
Anemia
1 (9)
1 (8)
2 (17)
0
0
1 (8)
Fatigue
0
1 (8)
1 (8)
0
0
2 (17)
Thrombocytopenia
1 (9)
1 (8)
1 (8)
0
0
0
Leukopenia
0
1 (8)
1 (8)
0
0
0
Diarrhea
0
0
0
0
2 (17)
0
a Includes all safety-evaluable RCC patients (cabo-exposed and cabo-naïve patients).
n (%)
Cabozantinib 40 mg
Cabozantinib 60 mg
Total N=70
Darlifarnib 3 mg n=11
Darlifarnib 5 mg n=12
Darlifarnib 8 mg n=12
Darlifarnib 3 mg
n= 11
Darlifarnib 5 mg n=12
Darlifarnib 8 mg n=12
Darli dose reduction
0
2 (17)
2 (17)
0
2 (17)
3 (25)
9 (13)
Darli interruption
5 (46)
7 (58)
7 (58)
3 (27)
9 (75)
11 (92)
42 (60)
Darli discontinuation
1 (9)
1 (8)
2 (17)
0
0
0
4 (6)
Cabo dose reduction
2 (18)
1 (8)
2 (17)
2 (18)
6 (50)
5 (42)
18 (26)
Cabo interruption
5 (46)
9 (75)
8 (67)
4 (36)
12 (100)
12 (100)
50 (71)
Very few patients required darlifarnib discontinuation or dose reduction, including in the darlifarnib + cabo 60 mg cohort, allowing patients to remain on therapy
Rates of cabozantinib dose interruptions for the 60mg dose appear consistent
with previous cabozantinib studies
aIncludes all safety-evaluable RCC patients (cabo exposed and cabo naive patients).
Data cutoff: Dec 8, 2025. 1
8
Cabozantinib 40 mg
Cabozantinib 60 mg
Total
N=16
Darlifarnib 3 mg
n=5
Darlifarnib 5 mg
n=6
Darlifarnib 8 mg
n=2b
Darlifarnib 3 mg
n=3
ORR (uPR + PR), n (%)
2 (40)
2 (33)c
1 (50)
2 (67)
7 (44)
95% CI
5.3-85.3
4.3-77.7
1.3-98.7
9.4-99.2
19.8-70.1
DCRd, n (%)
5 (100)
6 (100)
1 (50)
3 (100)
15 (94)
95% CI
47.8-100
54.1-100
1.3-98.7
29.2-100
69.8-99.8
ORR with subsequent treatment after prior cabo or other TKI exposure ~17% - 22%
All responders had progression on prior cabozantinib
4/7 responders had cabozantinib as immediate prior line of treatment
a Response-evaluable patients had ≥1 post-baseline scan. b One patient had only one disease assessment (PD as best response). c One patient had uPR. d DCR includes patients with SD and PR of any duration.
Best overall response in all response-evaluablea patients across dose levels
* Received darlifarnib 3 mg + cabo 60 mg; the remaining patients received cabo 40 mg in combination with darlifarnib 3, 5, or 8 mg. # Immediate prior cabo exposure.
& BOR of SD on prior cabo. % uPR. a Response-evaluable patients had ≥1 post-baseline scan.
Disclaimer
Kura Oncology Inc. published this content on April 17, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 17, 2026 at 15:59 UTC.