– Primary objective met with three
objective responses in nine patients with RAS wild-type tumor
status (33%), two additional RAS wild-type patients pending best
response evaluation –
Kura Oncology, Inc., (Nasdaq:KURA) a clinical-stage
biopharmaceutical company focused on the development of precision
medicines for oncology, today reported positive, preliminary
results from a Phase 2 clinical study of its lead candidate
tipifarnib in patients with chronic myelomonocytic leukemia (CMML).
The data were presented today at the American Society of Hematology
(ASH) Annual Meeting and Exposition in Atlanta. A copy of the
poster is now available on the company’s website at
www.kuraoncology.com.
The CMML study is one of four ongoing company-sponsored Phase 2
studies of tipifarnib. The open-label study is evaluating the
anti-tumor activity of tipifarnib as a single agent in patients
with CMML, retrospectively stratified based on RAS mutational
status. In addition, patient samples are analyzed for the presence
or absence of various biomarkers potentially relevant to the
activity of tipifarnib.
As of the data cutoff date of November 7, 2017, all nine
evaluable patients in the study with RAS wild-type CMML had
achieved stable disease or better, including three objective
responses as assessed using the MDS/MPN International Working Group
criteria. The primary objective of the study was met with an
overall response rate of 33% in patients with RAS wild-type CMML.
The study has enrolled 24 patients of whom 16 were evaluable for
response as of the data cutoff date. Nine patients had tumors with
RAS wild-type status and seven were RAS mutant.
“CMML is an aggressive malignancy with few therapeutic options,
particularly for those patients who have been treated with
hypomethylating agents,” said Eric Padron, M.D., of the Department
of Hematologic Malignancies at H. Lee Moffitt Cancer Center and
Research Institute in Tampa, Florida, a clinical investigator on
this study. “These encouraging preliminary data indicate that
tipifarnib has anti-tumor activity in a post-hypomethylating agent
setting and support further study of tipifarnib for the treatment
of CMML.”
“Although the signal observed in RAS wild-type patients is
encouraging, these data are still immature and time to event
endpoints cannot be yet fully evaluated. We continue to follow
these patients and evaluate biomarkers of activity, and look
forward to reporting additional data from this study in the year
ahead,” said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer
of Kura Oncology.
Patients receive tipifarnib administered at a starting dose of
900 mg, orally, twice a day for 7 days in alternating weeks in
28-day cycles. Tipifarnib was generally well-tolerated in the
study, with adverse events consistent with its known safety
profile.
In addition to the CMML study, Kura Oncology is also conducting
Phase 2 clinical trials in HRAS mutant head and neck squamous cell
carcinomas (HNSCC), peripheral T-cell lymphoma (PTCL) and
myelodysplastic syndrome (MDS). In September 2017, Kura Oncology
reported that its Phase 2 trial of tipifarnib in patients with HRAS
mutant 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 Chronic Myelomonocytic Leukemia
CMML is a clonal disorder of bone marrow stem cells that shares
characteristics of both myeloproliferative and myelodysplastic
diseases. CMML is characterized by increased monocytes and blasts
in the peripheral blood and bone marrow, as well as dysplasia in at
least one type of blood cell. The prognosis of CMML is poor, with a
median survival of 2 to 3 years, due in part to limited therapeutic
options. Hypomethylating agents are the most commonly used
therapeutic intervention in CMML.
About Tipifarnib
Kura Oncology’s lead candidate, tipifarnib, is a potent and
selective inhibitor of farnesyl transferase, a key cell signaling
process implicated in cancer initiation and development. In
extensive clinical trials, tipifarnib has shown a well-established
safety profile and 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, the company is seeking to identify patients most
likely to benefit from tipifarnib.
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 Kura Oncology’s product candidate, tipifarnib,
progress and expected timing of Kura Oncology’s drug development
programs and clinical trials, and plans regarding regulatory
filings and future research 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 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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