On November 28, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported 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) (Press release, Kura Oncology, NOV 28, 2018, View Source [SID1234531664]).
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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) (Free ASH Whitepaper) 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.