Kura Oncology Doses First Patient in KOMET-008 Trial of Ziftomenib in Combination with Standards of Care, Including FLT3 Inhibitor, in Acute Myeloid Leukemia
26 February 2024 - 11:30PM
Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage
biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer, today announced
that the first patient has been dosed in KOMET-008, the Company’s
Phase 1 trial of its menin inhibitor ziftomenib, in combination
with gilteritinib, FLAG-IDA or LDAC for the treatment of
NPM1-mutant or KMT2A-rearranged acute myeloid leukemia (AML).
“Roughly half of patients with relapsed or
refractory NPM1-mutant AML have co-occurring FLT3 mutations, and
the prognosis for these patients is particularly poor,” said
Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. “Given
the potential best-in-class safety and tolerability profile as well
as the robust monotherapy activity observed in our Phase 1 study of
ziftomenib, we believe an all-oral combination of ziftomenib and
gilteritinib may provide an attractive treatment option for these
patients.”
KOMET-008 is a Phase 1 study designed to assess
safety and tolerability, pharmacokinetics and evidence of clinical
activity of ziftomenib in combination with gilteritinib, FLAG-IDA
or LDAC for two genetically defined cohorts, NPM1-mutant AML and
KMT2A-rearranged AML, in the relapsed/refractory setting. Trial
participants will be enrolled in one of five dose escalation
cohorts, including a cohort of NPM1-mutant AML patients with a
documented FLT3 co-mutation, who will be treated in combination
with the FLT3 inhibitor gilteritinib. For more information
regarding KOMET-008, please visit www.clinicaltrials.gov
(identifier: NCT06001788).
Kura is conducting a series of studies to
evaluate ziftomenib in combination with current standards of care
in earlier lines of therapy and across multiple patient
populations. In July, the Company began dosing patients in the
first of these studies, KOMET-007, in combination with venetoclax
and azacitidine in patients with relapsed/refractory NPM1-mutant
and KMT2A-rearranged AML or in combination with standard induction
cytarabine/daunorubicin chemotherapy (7+3) in patients with
previously untreated NPM1-mutant and KMT2A-rearranged AML. Kura
reported positive preliminary data from 20 patients in KOMET-007 on
January 30, 2024.
Preclinical data for menin inhibitors in
combination with multiple FLT3 inhibitors demonstrate strong
synergistic effects compared to either single agent alone.
Currently there are no other actively recruiting clinical trials
evaluating the combination of a menin inhibitor with a FLT3
inhibitor for the treatment of AML.
About Acute Myeloid
Leukemia
AML is the most common acute leukemia in adults
and begins when the bone marrow makes abnormal myeloblasts (white
blood cells), red blood cells or platelets. Despite the many
available treatments for AML, prognosis for patients remains poor
and a high unmet need remains. The menin pathway is considered a
driver for multiple genetic alterations of the disease, of which
NPM1 mutations are among the most common, representing
approximately 30% of AML cases and KMT2A rearrangements represent
approximately 5-10% of AML cases. While patients with NPM1-m AML
have high response rates to frontline therapy, relapse rates are
high and survival outcomes are poor, with only 30% overall survival
at 12 months in the R/R setting. Additionally, NPM1 mutations
frequently occur with co-mutations in other disease-associated
genes, including FLT3, DNMT3A and IDH1/2, with prognosis heavily
influenced by the presence of co-occurring mutations. Adult
patients with NPM1-m AML and select co-mutations and/or R/R disease
have a poor prognosis, with median overall survival of only
approximately 7.8 months in 2nd line, 5.3 months in 3rd line and
3.5 months following the 4th line1. Adult patients with KMT2A-r AML
have a poor prognosis with high rates of resistance and relapse
following standard of care, with median overall survival for this
patient population of only 6 months following 2nd line and 2.4
months following 3rd line2. No FDA-approved therapies targeting
NPM1-m and KMT2A-r AML currently exist.
About Ziftomenib
Ziftomenib is a novel, once-daily, oral
investigational drug candidate targeting the menin-KMT2A/MLL
protein-protein interaction for treatment of genetically defined
AML patients with high unmet need. Ziftomenib inhibits the
KMT2A/MLL protein complex and exhibits downstream effects on
HOXA9/MEIS1 expression and potent anti-leukemic activity in
genetically defined preclinical models of AML. Ziftomenib has
received Orphan Drug Designation from the U.S. Food and Drug
Administration for the treatment of AML. Additional
information about clinical trials for ziftomenib can be found
at kuraoncology.com/clinical-trials/#ziftomenib.
About Kura Oncology
Kura Oncology is a clinical-stage
biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer. The Company’s
pipeline consists of small molecule drug candidates that target
cancer signaling pathways. Ziftomenib is a once-daily, oral drug
candidate targeting the menin-KMT2A protein-protein interaction for
the treatment of genetically defined AML patients with high unmet
need. Kura is currently enrolling patients in a Phase 2
registration-directed trial of ziftomenib in NPM1-mutant relapsed
or refractory AML (KOMET-001). The Company is also conducting a
series of studies to evaluate ziftomenib in combination with
current standards of care, beginning with venetoclax and
azacitidine and 7+3 in NPM1-mutant and KMT2A-rearranged newly
diagnosed and relapsed/refractory AML (KOMET-007). Tipifarnib, a
potent and selective farnesyl transferase inhibitor (FTI), is
currently in a Phase 1/2 trial in combination with alpelisib for
patients with PIK3CA-dependent head and neck squamous cell
carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a
next-generation FTI, in a Phase 1 dose-escalation trial as a
monotherapy and in combination with adagrasib in KRASG12C-mutated
non-small cell lung cancer and cabozantinib in clear cell renal
cell carcinoma (FIT-001). For additional information, please visit
Kura’s website at www.kuraoncology.com and follow us
on X and LinkedIn.
Forward-Looking Statements
This news release contains certain
forward-looking statements that involve risks and uncertainties
that could cause actual results to be materially different from
historical results or from any future results expressed or implied
by such forward-looking statements. Such forward-looking statements
include statements regarding, among other things, the efficacy,
safety and therapeutic potential of ziftomenib, potential benefits
of combining ziftomenib with appropriate standards of care, and
progress and expected timing of the ziftomenib program and clinical
trials. Factors that may cause actual results to differ materially
include the risk that compounds that appeared promising in early
research or clinical trials do not demonstrate safety and/or
efficacy in later preclinical studies or clinical trials, the risk
that Kura may not obtain approval to market its product candidates,
uncertainties associated with performing clinical trials,
regulatory filings, applications and other interactions with
regulatory bodies, risks associated with reliance on third parties
to successfully conduct clinical trials, risks associated with
reliance on outside financing to meet capital requirements, and
other risks associated with the process of discovering, developing
and commercializing drugs that are safe and effective for use as
human therapeutics, and in the endeavor of building a business
around such drugs. You are urged to consider statements that
include the words “may,” “will,” “would,” “could,” “should,”
“believes,” “estimates,” “projects,” “promise,” “potential,”
“expects,” “plans,” “anticipates,” “intends,” “continues,”
“designed,” “goal,” or the negative of those words or other
comparable words to be uncertain and forward-looking. For a further
list and description of the risks and uncertainties the Company
faces, please refer to the Company's periodic and other filings
with the Securities and Exchange Commission, which are
available at www.sec.gov. Such forward-looking statements are
current only as of the date they are made, and Kura assumes no
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Contacts
Investors:Pete De SpainExecutive Vice President, Investor
Relations &Corporate Communications(858)
500-8833pete@kuraoncology.com
Media:Alexandra WeingartenAssociate Director, Corporate
Communications & Investor Relations(858)
500-8822alexandra@kuraoncology.com
1 Issa GC, et al. Blood Adv. 2023;7(6):933-42.2
Issa GC, et al. Blood Cancer J. 2021;11(9):162.
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