Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage
biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer, today reported
preliminary clinical data from the first 20 patients in KOMET-007,
a Phase 1 dose-escalation trial of the Company’s potent and
selective menin inhibitor, ziftomenib, in combination with
standards of care, including cytarabine/daunorubicin (7+3) and
venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant
(NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia
(AML).
The first 20 patients were enrolled in KOMET-007 between July
2023 and November 2023, including five newly diagnosed patients
with adverse risk1 NPM1-m or KMT2A-r AML and 15 patients with
refractory/relapsed (R/R) NPM1-m or KMT2A-r AML.
Continuous daily dosing of ziftomenib at 200 mg QD has been well
tolerated and the safety profile consistent with features of
underlying disease and backbone therapies. No differentiation
syndrome events of any grade were reported, and no dose-limiting
toxicities, evidence of QTc prolongation, drug-drug interactions or
additive myelosuppression were observed.
As of the data cutoff on January 11, 2024, all newly diagnosed
patients treated with ziftomenib and 7+3 achieved a complete
remission (CR) with full count recovery, for a CR rate of 100%
(5/5), including four patients with NPM1-m AML and one patient with
KMT2A-r AML.
The overall response rate (ORR) among R/R patients treated with
ziftomenib and ven/aza was 53% (8/15). Among all patients treated
with ziftomenib and ven/aza, 40% (6/15) received prior treatment
with a menin inhibitor. The CR/CRh2 rate in patients who were menin
inhibitor naïve was 56% (5/9), including 60% (3/5) in patients with
NPM1-m AML and 50% (2/4) in patients with KMT2A-r AML. The ORR in
patients who received prior venetoclax was 40% (4/10), including
60% (3/5) in patients with NPM1-m AML.
As of the data cutoff, 80% (16/20) of patients remain on trial,
including 100% (11/11) of all NPM1-m patients.
“Ziftomenib is one of the most exciting investigational agents
being studied in AML, and I am thrilled to see the rapid pace of
accrual into this first-in-human combinational study,” said Amer
Zeidan, MBBS, MHS, interim chief of the Division of Hematologic
Malignancies, Director of Hematology Early Therapeutics Research at
Yale Cancer Center and lead investigator of the KOMET-007 trial.
“In this first public release of early data from the KOMET-007
trial, ziftomenib demonstrates an encouraging safety and
tolerability profile in combination with 7+3 and ven/aza, enabling
continuous administration while mitigating the risk of
differentiation syndrome. The combinations demonstrate encouraging
preliminary evidence of clinical activity in patients with
refractory/relapsed disease after failure of other agents,
including venetoclax, a setting with very limited effective
treatment options. Further, the fact that most patients remain on
study as of the data cutoff is notable in such difficult-to-treat
patient populations.”
The 200 mg dose of ziftomenib has been cleared in the R/R
ven/aza cohorts and enrollment at the 400 mg dose is ongoing. Upon
determination of a recommended Phase 2 dose, Kura plans to initiate
a Phase 1b dose validation/expansion in combination with ven/aza in
newly diagnosed patients with NPM1-m (without adverse risk) or
KMT2A-r AML.
“We are highly encouraged by these preliminary combination data
for ziftomenib and believe they support advancement into the
frontline AML population,” said Troy Wilson, Ph.D., J.D., President
and Chief Executive Officer of Kura Oncology. “Given that
ziftomenib targets foundational mutations at the core of up to 50%
of AML cases, we are encouraged by its potential to transform
treatment outcomes across the continuum of care. We continue to see
strong investigator enthusiasm as evidenced by rapid enrollment
across studies, and we expect to complete enrollment of all 85
patients in KOMET-001, our Phase 2 registration-directed trial of
ziftomenib in patients with R/R NPM1-m AML, by the middle of this
year. With the recently announced financing, we remain in a strong
financial position with cash runway expected into 2027, which
enables us to invest aggressively in research, development and
pre-commercial activities to maximize value of ziftomenib and other
pipeline assets.”
Virtual Investor Event
Kura will host a virtual investor event featuring company
management and investigators from the KOMET-007 trial of ziftomenib
today at 8:00 a.m. ET. The live call may be accessed by dialing
(800) 715-9871 for domestic callers and (646) 307-1963 for
international callers and entering the conference ID: 7854712. A
live webcast will be available here and in the Investors section of
Kura’s website, with an archived replay available shortly after the
event.
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
occurrence 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 months in 3rd line and 3.5 months following
the 4th line3. 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 line4. 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. In preclinical models, 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-m R/R AML (KOMET-001). The Company is
also conducting a series of studies to evaluate ziftomenib in
combination with current standards of care, beginning with ven/aza
and 7+3 in NPM1-m and KMT2A-r newly diagnosed and R/R 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
cabozantinib in clear cell renal cell carcinoma and adagrasib in
KRASG12C-mutated non-small cell lung cancer (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, plans regarding future clinical
trials in the ziftomenib program, plans and expected timing for
enrollment in the Phase 2 registration-directed trial of
ziftomenib, and the Company’s cash runway. 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 Kura’s cash needs, the 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 (SEC), including the
Company’s Form 10-Q for the quarter ended September 30, 2023 filed
with the SEC on November 2, 2023, 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.
Amer Zeidan has consulted and received honoraria from Kura.
Opinions expressed are his own and do not necessarily represent
those of his employer.
Contacts
Investors: Pete De Spain Executive Vice President,
Investor Relations & Corporate Communications (858)
500-8833 pete@kuraoncology.com
Media: Alexandra Weingarten Associate
Director, Investor Relations &Corporate
Communications (858)
500-8822 alexandra@kuraoncology.com
1 Age > 60 years and/or treatment-related AML and/or adverse
risk cytogenetics per European LeukemiaNet (ELN)2 CR with partial
hematologic recovery3 Issa G, et al. Blood Adv 2023;7(6):933-42.4
Issa GC, et al. Blood Cancer J. 2021;11(9):162.
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