Kura Oncology, Inc. (Nasdaq:KURA) announced on 5/2/18 that the U.S. Patent and Trademark Office (USPTO) has issued a new patent protecting the company's lead product candidate, tipifarnib. 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.”
In a recent Ph II study five out of the six evaluable patients achieved a confirmed, partial response as defined by standard RECIST criteria for an overall response rate of 83% (36-99.6%, 95%CI), including durable responses of more than 18 months in two patients. The sixth evaluable patient experienced tumor shrinkage and prolonged disease stabilization. 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.
Tipifarnib is a, 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