– AITL patent expands protection for tipifarnib, provides exclusivity in U.S. to 2037 –
– Prospective data from AITL and CXCL12+ cohorts in Phase 2 trial of tipifarnib in PTCL upcoming at ASH 2018
–
SAN DIEGO, Nov. 28, 2018 (GLOBE NEWSWIRE) -- 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 Spain
Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
pete@kuraoncology.com
Investors:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com
Media:
Jason Spark
Managing Director
Canale Communications
(619) 849-6005
jason@canalecomm.com
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