Kura Oncology Announces Positive Phase 2 Study for Tipifarnib in HRAS Mutant Head and Neck Cancer
September 07 2017 - 4:05PM
Four of the first six HRAS mutant HNSCC
patients enrolled on study achieve confirmed RECIST partial
responses
Kura Oncology, Inc., (Nasdaq:KURA) a clinical stage
biopharmaceutical company focused on the development of precision
medicines for oncology, today announced positive topline results
from a Phase 2 trial for its lead product candidate, tipifarnib, in
patients with HRAS mutant relapsed or refractory squamous cell
carcinomas of the head and neck (HNSCC). The Phase 2 trial achieved
its primary endpoint prior to the completion of enrollment.
The trial protocol requires four confirmed, partial responses,
per RECIST 1.1 criteria, out of 18 patients to meet its primary
endpoint. Four confirmed, partial responses and two patients with
disease stabilization have been observed among the first six
evaluable HNSCC patients enrolled in the trial. In addition,
objective responses greater than one year in duration have already
been observed in two patients. All patients joined the study upon
progression on prior therapy, including chemotherapy, cetuximab or
immune therapy. Kura will continue to enroll HRAS mutant HNSCC
patients and plans to present data from the study at an upcoming
scientific or medical conference.
“We have observed rapid and, in some cases, dramatic responses
in patients with relapsed and/or refractory HNSCC who do not appear
to benefit from other therapies,” said Antonio Gualberto, M.D.,
Ph.D., Chief Medical Officer of Kura Oncology. “Based on these very
encouraging results, we are exploring available options to advance
the development of tipifarnib in this patient population as quickly
as possible.”
About HRAS Mutant HNSCC
Head and neck cancer is one of the leading causes of
cancer-related deaths worldwide, with squamous cell carcinomas
accounting for most head and neck cancers. Response rates for the
three agents approved for treatment of HNSCC in the second line,
including cetuximab and immune therapy agents, are in the range of
13-16%, and median overall survival is up to 7.5 months. HRAS is a
proto-oncogene that has been implicated in the development and
progression of HNSCC and has been established to be uniquely
farnesylated.
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. Kura’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 tipifarnib drug development program 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:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com
CORPORATE COMMUNICATIONS CONTACT:
Mark Corbae
Vice President
Canale Communications
(619) 849-5375
mark@canalecomm.com
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