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 an investigator-sponsored Phase 2 trial of its lead drug
candidate, tipifarnib, in patients with relapsed or refractory
urothelial carcinomas that carry HRAS mutations.
The ongoing, single-agent, single-arm trial is designed to
enroll at least 18 patients, with a primary endpoint of
progression-free survival (PFS) rate at 6 months. Secondary
endpoints include objective response rate, duration of response and
safety. The trial is being conducted at the Samsung Medical Center
in Korea.
To date, more than 200 patients with relapsed or refractory
urothelial carcinoma have been screened for the presence of tumor
HRAS mutations. A total of 15 patients were identified to carry
tumors with HRAS mutations. Two patients withdrew from the trial
prior to their first response assessment. Of the 13 evaluable
patients, five experienced confirmed objective responses, according
to RECIST 1.1 criteria, for an overall response rate of 38%.
Notably, four patients have experienced PFS of greater than 6
months. According to the trial protocol, the primary endpoint is
met when at least four patients achieve PFS at 6 months.
“Although the treatment paradigm for advanced urothelial
carcinoma has evolved with the introduction of checkpoint
inhibitors, there remains a need for more precise and effective
treatment options for these patients,” said Se Hoon Park, M.D.,
Ph.D., Samsung Medical Center, principal investigator for the
trial. “These biomarker-driven data in patients with relapsed or
refractory urothelial carcinoma are promising and further
underscore the potential for tipifarnib in HRAS mutant solid
tumors.”
All patients joined the trial upon progression from at least one
prior systemic chemotherapy cycle, with a median of one prior
therapy. Tipifarnib has been generally well-tolerated in the trial;
adverse events observed are consistent with the known safety
profile of tipifarnib. Further analyses of the trial are ongoing,
and detailed data are expected to be presented at a future medical
meeting.
“We are very encouraged to see that this investigator-sponsored
trial in HRAS mutant urothelial carcinoma met its primary endpoint
prior to the completion of enrollment,” said Antonio Gualberto,
M.D., Ph.D., Head of Development and Chief Medical Officer of Kura
Oncology. “This study represents the fourth clinical
proof-of-concept for tipifarnib and the second proof-of-concept in
a HRAS mutant solid tumor indication. We believe that more than
five percent of urothelial carcinoma patients carry the HRAS
mutation, which represents a meaningful additional market
opportunity for tipifarnib. Based on these results, we are
currently evaluating next steps for tipifarnib in this indication
and look forward to the presentation of the full data set at an
upcoming medical meeting.”
About Urothelial Carcinoma
Urothelial carcinoma, also known as transitional cell carcinoma,
develops from urothelial cells that line the inside of the bladder.
Urothelial carcinoma accounts for 90 percent of all bladder
cancers, and can also arise in the renal pelvis and ureters. The
American Cancer Society estimates approximately 80,470 new cases of
bladder cancer in the United States for 2019. Despite the approval
of checkpoint inhibitors in recent years, the treatment of patients
with advanced urothelial carcinoma in the second-line setting
remains a significant unmet need.
About Tipifarnib
Kura Oncology’s lead drug candidate, tipifarnib, is a potent,
selective and orally bioavailable inhibitor of farnesyl transferase
in-licensed from Janssen in December 2014. Previously, tipifarnib
was studied in more than 5,000 cancer patients and showed
compelling and durable anti-cancer activity in certain patient
subsets; however, no molecular mechanism of action had been
determined that could explain its clinical activity across a range
of solid tumor and hematologic indications. Leveraging advances in
next-generation sequencing as well as emerging information about
cancer genetics and tumor biology, Kura is seeking to identify
those patients most likely to benefit from tipifarnib. In November
2018, following an end of Phase 2 meeting with the U.S. Food and
Drug Administration, Kura initiated its first registration-directed
trial of tipifarnib in patients with recurrent or metastatic HRAS
mutant head and neck squamous cell carcinoma (HNSCC). In addition
to HRAS mutant HNSCC and HRAS mutant urothelial carcinoma, the
Company has achieved clinical proof-of-concept with tipifarnib in
angioimmunoblastic T-cell lymphoma and CXCL12-expressing peripheral
T-cell lymphoma.
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, currently in a Phase 1 dose-escalation trial, and
KO-539, a menin-MLL inhibitor, which is entering a Phase 1 clinical
trial. 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 tipifarnib, the market
potential for tipifarnib, and progress and expected timing of
Kura’s drug development programs 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 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 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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