Kura Oncology Announces New Patent for Tipifarnib in Angioimmunoblastic T-Cell Lymphoma
November 28 2018 - 07:30AM
– AITL patent expands protection for tipifarnib,
provides exclusivity in U.S. to 2037 –
Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage
biopharmaceutical company focused on the development of precision
medicines for oncology, today announced that the U.S. Patent and
Trademark Office (USPTO) has issued a new patent protecting the
Company's lead drug candidate, tipifarnib, a potent and selective
farnesyl transferase that is currently being studied in multiple
solid tumor and hematologic indications, including a
registration-directed trial in HRAS mutant head and neck squamous
cell carcinoma (HNSCC) and a Phase 2 trial in peripheral T-cell
lymphoma (PTCL).
U.S. Patent No. 10,137,121, “Methods of Treating Cancer with
Farnesyltransferase Inhibitors,” includes multiple claims directed
to the use of tipifarnib as a method of treating patients with
angioimmunoblastic T-cell lymphoma (AITL), an aggressive form of
T-cell lymphoma. The newly issued patent has an expiration date of
November 2037, excluding any possible patent term extension. Kura
continues to pursue U.S. and foreign patent protection in this and
other indications.
“The issuance of this new patent is an important achievement for
Kura and reflects our ability to expand the breadth and depth of
tipifarnib’s development opportunities,” said Troy Wilson, Ph.D.,
President and CEO of Kura Oncology. “This patent comes just six
months after the USPTO issued us a patent for the use of tipifarnib
as method of treating patients with certain CXCL12-expressing
cancers, further strengthening our intellectual property protection
for tipifarnib based on genetically defined patient populations and
disease indications.”
Kura is evaluating, on a prospective basis, the role of the
CXCL12 pathway and markers of bone marrow homing as potential
biomarkers of clinical activity for tipifarnib in hematologic
malignancies. The Company’s ongoing Phase 2 trial of tipifarnib in
PTCL is enrolling patients into two expansion cohorts. The first
cohort is defined by histology and includes patients with AITL. The
second cohort is defined by genetics and includes patients with
PTCL not otherwise specified (NOS) who have the absence of a single
nucleotide variation in the 3’ untranslated region of the CXCL12
gene. The Company estimates that the combined addressable
populations of patients with AITL and CXCL12+ account for
approximately 40% of all PTCL cases.
Kura plans to report preliminary data from both expansion
cohorts in its Phase 2 trial of tipifarnib at the upcoming
American Society of Hematology (ASH) Annual Meeting in San
Diego on Sunday, December 2, 2018. A copy of the poster will be
available on the Company's website at www.kuraoncology.com
following presentation at the meeting.
About Tipifarnib
Kura Oncology’s lead candidate, tipifarnib, is an inhibitor of
farnesylation, a key cell signaling process implicated in cancer
initiation and development. Tipifarnib was previously studied in
more than 5,000 cancer patients and showed compelling and durable
anti-cancer activity in certain patient subsets with a manageable
side effect profile. Leveraging advances in next-generation
sequencing as well as emerging information about cancer genetics
and tumor biology, the Company is seeking to identify those
patients most likely to benefit from tipifarnib. Based on positive
results from a Phase 2 clinical trial in HRAS mutant HNSCC and
feedback from the U.S. Food and Drug Administration, Kura recently
initiated a global, registration-directed trial of tipifarnib in
patients with recurrent or metastatic HRAS mutant HNSCC.
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 has initiated
a registration-directed trial of tipifarnib 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, currently
in IND-enabling studies. 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 and the Company’s other product candidates,
the conduct, results and timing of Kura Oncology’s clinical trials
plans regarding future clinical trials and development and
commercial activities, the regulatory approval path for tipifarnib
and expectations regarding intellectual property and biomarkers
related to Kura Oncology’s product candidates. 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,” “anticipated,” “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.
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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