On May 2, 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 product candidate, tipifarnib (Press release, Kura Oncology, MAY 2, 2018, View Source [SID1234525943]).
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U.S. patent 9,956,215, "Methods of Treating Cancer Patients with Farnesyltransferase Inhibitors," includes multiple claims directed to the use of tipifarnib as a method of treating patients with CXCL12-expressing peripheral T-cell lymphoma (PTCL) or acute myeloid leukemia (AML). 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 these and other indications.
"We are excited by the potential opportunity for tipifarnib in hematologic malignancies, and this new patent represents an important milestone in our development plan," said Troy Wilson, Ph.D., President and CEO of Kura Oncology. "In addition, the issuance of this patent comes less than one year after the USPTO issued a similar patent for tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC), reinforcing the potential of our broader strategy to generate intellectual property related to the use of our drug candidates in genetically defined patient populations."
"Although tipifarnib has been known to be clinically active in hematologic malignancies for over a decade, a precise molecular mechanism of action was never elucidated and few if any clinical trials using genetic selection were conducted," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "At Kura, we discovered that the CXCL12 pathway is a potential target for tipifarnib, and markers of CXCL12 pathway activation may provide methods to select or stratify patients who are most likely to benefit from tipifarnib therapy."
In December 2017, Kura presented new findings at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting that identified activation of the CXCL12 pathway and bone marrow homing of myeloid cells as potential biomarkers of tipifarnib’s activity in certain hematologic malignancies, including PTCL, AML, myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Based on these observations, the company is now working to prospectively validate these potential biomarkers in its ongoing Phase 2 trials of tipifarnib in hematologic malignancies. Kura expects biomarker-enriched data from these ongoing Phase 2 trials in the second half of 2018.
About Tipifarnib
Tipifarnib is a potent, selective and orally bioavailable inhibitor of the enzyme farnesyl transferase. Tipifarnib was previously studied in more than 5,000 cancer patients and demonstrated compelling and durable anti-cancer activity in certain patients with a manageable side effect profile. Following a positive Phase 2 trial in HRAS mutant HNSCC and a successful end of Phase 2 meeting with the FDA, Kura is planning to conduct a global, registration-directed trial of tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant HNSCC. The trial, called AIM-HN, is expected to initiate in the second half of 2018.