– Newly issued patent expands protection for tipifarnib in U.S., provides exclusivity in certain CXCL12-expressing cancers to 2037 –
– Second U.S. patent for tipifarnib reinforces potential for broader strategy to provide commercial exclusivity based upon biomarker-guided development –
– Biomarker-enriched data from ongoing Phase 2 trials of tipifarnib in hematologic malignancies expected in second half of 2018 –
SAN DIEGO, May 02, 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 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.”
“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) 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.
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.
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 Oncology’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple 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 trial, and KO-539, an inhibitor of the menin-MLL protein-protein interaction, currently in preclinical development. For additional information about Kura Oncology, please visit the company’s website at www.kuraoncology.com.
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 the company’s product candidates, progress and expected timing of Kura Oncology’s drug development programs and clinical trials, plans regarding future clinical trials and development activities and expectations regarding intellectual property and biomarkers related to Kura Oncology’s drug 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.
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