Kura Oncology Doses First Patient in Phase 1 Clinical Trial of Menin-MLL Inhibitor KO-539 in Acute Myeloid Leukemia
September 16 2019 - 6:30AM
Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage
biopharmaceutical company focused on the development of precision
medicines for the treatment of cancer, today announced that the
first patient has been dosed in a Phase 1 clinical trial of KO-539,
the Company’s first-in-class inhibitor of the menin-mixed lineage
leukemia (menin-MLL) interaction, in patients with relapsed or
refractory acute myeloid leukemia (AML).
“We believe KO-539 represents a differentiated approach to the
treatment of patients with AML,” said Troy Wilson, Ph.D., J.D.,
President and Chief Executive Officer of Kura Oncology. “Our
preclinical data for KO-539 support the potential for potent,
anti-tumor activity in multiple, genetically defined subsets such
as tumors with MLL fusions and rearrangements and NPM1 mutations.
With the initiation of this trial, Kura now has three wholly-owned,
clinical-stage oncology assets, along with the financial resources
to advance each program through important inflection points.”
This Phase 1, open-label, dose-escalation study is designed to
determine the maximum tolerated dose (MTD) of KO-539 in patients
with relapsed or refractory AML. KO-539 will be administered as a
once daily oral dose in 28-continuous-day cycles. Upon completion
of the dose-escalation portion of the trial, expansion cohorts are
planned to further asses the safety and activity of KO-539 in
specific genetic subgroups, such as NPM1. Additional information
about the Phase 1 trial of KO-539 can be found at
ClinicalTrials.gov using the identifier NCT04067336.
In July 2019, the U.S. Food and Drug Administration granted
Orphan Drug Designation to KO-539 for the treatment of AML,
recognizing the potential for KO-539 to address a population of
patients with high unmet need.
About KO-539
KO-539 is a potent and selective small molecule inhibitor of the
menin-MLL protein-protein interaction. MLL-rearranged leukemias are
characterized by chromosomal translocations of the KMT2A gene that
are primarily found in patients with AML and acute lymphoblastic
leukemia (ALL). These translocations form oncogenes encoding MLL
fusion proteins, which play a causative role in the onset,
development and progression of MLL-rearranged leukemias. The target
genes of the MLL fusion proteins are also found to be overexpressed
in a broader subset of AMLs characterized by oncogenic driver
mutations in genes, such as NPM1. These mutations also appear to be
dependent on the interaction between menin and MLL, suggesting that
the menin-MLL complex is a central node in epigenetic dysregulation
driven by distinct oncogenic driver mutations known to be important
in AML and other hematologic malignancies.
In preclinical studies, KO-539 has demonstrated potent and
selective inhibition of the proliferation of MLL-rearranged
leukemia cell lines. Kura has also generated preclinical data
showing robust and durable anti-tumor activity in multiple in vivo
models of AML characterized by MLL-rearrangements or oncogenic
driver mutations in genes, such as NPM1.
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
where there is a strong scientific and clinical rationale to
improve outcomes by identifying those patients most likely to
benefit from treatment. Kura’s lead drug candidate is tipifarnib, a
farnesyl transferase inhibitor, for which the Company is conducting
a registration-directed trial in recurrent or metastatic patients
with HRAS mutant HNSCC. In addition, tipifarnib is being evaluated
in multiple other Phase 2 clinical trials in solid tumor and
hematologic indications. Kura’s pipeline also includes KO-947, an
ERK inhibitor, and KO-539, a menin-MLL inhibitor, both of which are
currently in Phase 1 dose-escalation trials. For additional
information about Kura, please visit the Company’s website at
www.kuraoncology.com.
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 Kura’s product candidate KO-539, the progress and
expected timing of Kura’s drug development programs and clinical
trials and the potential benefits of Orphan Drug Designation.
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 and applications, risks associated with reliance
on third parties to successfully conduct clinical trials, the risks
associated with reliance on outside financing to meet capital
requirements, risks that the actual benefits of Orphan Drug
Designation will not be as expected 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
Company:Pete De SpainVice President, Investor Relations
&Corporate Communications(858)
500-8803pete@kuraoncology.com
Investors:Robert H. UhlManaging DirectorWestwicke Partners,
LLC(858) 356-5932robert.uhl@westwicke.com
Media:Jason SparkManaging DirectorCanale Communications(619)
849-6005jason@canalecomm.com
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