Kura Oncology Doses First Patient in Phase 2 Study of Tipifarnib in Chronic Myelomonocytic Leukemia
January 17, 2017 at 07:30 am
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Kura Oncology, Inc. announced that the first patient has been dosed in its Phase 2 clinical trial of tipifarnib in patients with chronic myelomonocytic leukemia (CMML). Objective responses, including complete responses, have been previously observed with tipifarnib in CMML. Goals with this Phase 2 study are to confirm the level of activity of tipifarnib in this patient population as well as to validate biomarker hypotheses that may allow it to identify those patients most likely to experience durable responses. This Phase 2 clinical trial is designed to enroll approximately 20 patients with CMML and will evaluate the antitumor activity of tipifarnib in terms of overall response rate. Patients will receive tipifarnib administered orally, twice a day for 7 days in alternating weeks in 28 day cycles. Patient samples will be analyzed for the presence or absence of various biomarkers potentially relevant to the activity of tipifarnib. CMML is a clonal disorder of bone marrow stem cells that shares characteristics of both myeloproliferative and myelodysplastic diseases. CMML is characterized by increased monocytes and blasts in the peripheral blood and bone marrow, as well as dysplasia in at least one type of blood cell. CMML is estimated to have an annual incidence of approximately 1,400 patients in the United States. These patients generally have a poor prognosis due to limited therapeutic options with only a 29% survival rate three years after diagnosis. Tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura Oncology is seeking to identify patients most likely to benefit from tipifarnib.
Kura Oncology, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on precision medicine for the treatment of cancer. Its pipeline consists of small molecule product candidates that target cancer signaling pathways. Its product candidates include Ziftomenib, Tipifarnib and KO-2806. Ziftomenib, is a potent, selective, reversible and oral small molecule inhibitor that blocks the interaction of two proteins, menin and the protein expressed by the Lysine K-specific Methyl Transferase 2A gene, or KMT2A gene. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined acute myeloid leukemia patients with high unmet need. Tipifarnib is a potent, selective and orally bioavailable farnesyl transferase inhibitor (FTI). The KO-2806 is a next-generation FTI, which demonstrates improved potency, pharmacokinetic and physicochemical properties relative to earlier FTI drug candidates.
KURA ONCOLOGY, INC. 
