CXCR4/CXCR2 expression ratio and bone
marrow homing of myeloid cells identified as potential markers for
tipifarnib in MDS, AML and CMML
Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage
biopharmaceutical company focused on the development of precision
medicines for oncology, today reported new findings supporting the
development of lead candidate tipifarnib, a potent and selective
inhibitor of farnesyl transferase, in the treatment of certain bone
marrow cancers. These results were featured in presentations at the
American Society of Hematology (ASH) Annual Meeting and Exposition
in Atlanta. Copies of the posters are now available on the
company’s website at www.kuraoncology.com.
Among the findings presented at ASH were the identification of
CXCR4/CXCR2 expression ratio and bone marrow homing of myeloid
cells as potential biomarkers of tipifarnib activity across the
bone marrow cancers, myelodysplastic syndromes (MDS), acute myeloid
leukemia (AML) and chronic myelomonocytic leukemia (CMML), further
showing that the CXCL12/CXCR4 pathway is a potential therapeutic
target of farnesyl transferase inhibitors.
“Although tipifarnib has previously demonstrated clinical
responses in certain patients with AML and MDS, no molecular
mechanism of action was identified that could explain the activity
of the drug candidate in those patient populations,” said Troy
Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura
Oncology. “These new findings are exciting because they may define
potential biomarkers for tipifarnib in bone marrow tumors and
characterize a subgroup of patients that are most likely to derive
clinical benefit from a targeted therapy such as tipifarnib.”
Previously, Kura Oncology reported preliminary results from an
ongoing Phase 2 clinical trial of tipifarnib in patients with
peripheral T-cell lymphoma (PTCL) identifying the CXCL12/CXCR4
pathway as a potential target of tipifarnib. Specifically, high
levels of CXCL12 gene expression and absence of single nucleotide
gene variations in the 3'-untranslated region of the CXCL12 gene
were associated with observed clinical activity of tipifarnib in
these PTCL patients.
In the ASH presentation entitled, “The CXCL12/CXCR4 Pathway As a
Potential Target of Tipifarnib: Preliminary Results from an
Open-Label, Phase II Study in Relapsed or Refractory Peripheral
T-Cell Lymphoma,” Kura Oncology extends these observations and
provides data supporting the observed tipifarnib-derived clinical
benefit for the CXCL12-positive population.
CXCL12 is a chemokine that is secreted in large amounts by lymph
nodes, bone marrow stroma, liver, and lung, and plays key roles in
tumor invasion, bone marrow homing and site of metastasis. Among
its multiple functions, CXCL12 is essential for homing of myeloid
cells to the bone marrow and lymphoid cells to lymph nodes and
other organs.
Based on its initial observations in PTCL, the company
investigated a role for the CXCL12/CXCR4 pathway and bone marrow
homing of myeloid cells as biomarkers of tipifarnib activity in AML
and MDS studies.
In the ASH presentation entitled, “The CXCL12/CXCR4 Pathway As a
Potential Target of Tipifarnib in Acute Myeloid Leukemia and
Myelodysplastic Syndromes,” Kura Oncology presented results that
identify the ratio of CXCR4/CXCR2 gene expression and bone marrow
homing of myeloid cells as potential biomarkers of the activity of
tipifarnib in certain bone marrow tumors. The results were obtained
by analyzing data from previous studies of tipifarnib in AML and
MDS, as well as data from the ongoing Phase 2 clinical trial of
tipifarnib in CMML.
“We were very encouraged to identify CXCR4/CXCR2 expression
ratio and bone marrow homing as markers of tipifarnib’s activity in
MDS, AML and CMML,” said Antonio Gualberto, M.D., Ph.D., Chief
Medical Officer at Kura Oncology. “Although our analysis is
retrospective, the fact that we observe a consistent clinical
benefit across different endpoints, treatment settings and
indications gives us increased confidence in the potential for
these biomarkers. Based on our preliminary data, we believe
CXCL12/CXCR4 may have the potential to unlock the therapeutic value
of farnesyl transferase inhibition across multiple bone marrow
neoplasias.”
About Tipifarnib
Kura Oncology’s lead candidate, tipifarnib, is a potent and
selective inhibitor of the enzyme farnesyl transferase, a key cell
signaling process implicated in cancer initiation and development.
Tipifarnib has previously been studied in more than 5,000 patients
in more than 70 clinical trials has a well-established safety
profile and has demonstrated compelling and durable anti-cancer
activity in certain patient subsets.
Leveraging advances in next-generation sequencing as well as
emerging information about cancer genetics and tumor biology, Kura
Oncology is seeking to identify patients most likely to benefit
from tipifarnib. The company is conducting clinical and preclinical
studies in multiple disease indications where tipifarnib has
previously shown signs of activity with the goal of identifying and
validating biomarkers associated with the observed clinical
activity of tipifarnib.
In September 2017, Kura Oncology reported that its Phase 2 trial
of tipifarnib in patients with HRAS mutant head and neck squamous
cell carcinomas (HNSCC) achieved its primary efficacy endpoint
prior to the completion of patient enrollment. The company is now
planning to initiate a registration-enabling study of tipifarnib in
HRAS mutant HNSCC in 2018.
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 Oncology’s lead drug candidate is
tipifarnib, a farnesyl transferase inhibitor, which is currently
being studied in multiple Phase 2 clinical trials. The company’s
pipeline also includes KO-947, an ERK inhibitor, currently in a
Phase 1 trial, and KO-539, an inhibitor of the menin-MLL
protein-protein interaction, currently in preclinical testing. For
additional information about Kura Oncology, 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 tipifarnib, progress and expected timing of Kura
Oncology’s drug development programs and clinical trials and plans
regarding future clinical trials and development activities.
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
Oncology 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, 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 Oncology
assumes no obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
CONTACT INFORMATION
INVESTOR CONTACT:Pete De SpainVice President, Investor Relations
&Corporate CommunicationsKura Oncology, Inc.(858)
500-8803pete@kuraoncology.com
MEDIA CONTACT:Mark CorbaeVice PresidentCanale
Communications(619) 849-5375mark@canalecomm.com
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