Kura Oncology Inc (NASDAQ:KURA) just announced preliminary data in angioimmunoblastic T-cell lymphoma (AITL) and CXCL12+ peripheral T-cell lymphoma (PTCL), the two expansion cohorts in its Phase 2 clinical trial of its lead drug candidate tipifarnib in patients with relapsed or refractory PTCL.

According to the release, the data, presented today at the American Society of Hematology (ASH) Annual Meeting in San Diego, showed encouraging activity with tipifarnib in late-stage PTCL patients, including a significant association between CXCL12 expression and clinical benefit, and proof of concept in AITL, an aggressive form of T-cell lymphoma often characterized by high levels of CXCL12 expression.

Kura Oncology Inc (NASDAQ:KURA) trumpets itself as a clinical-stage biopharmaceutical company develops medicines for the treatment of cancers. Its pipeline consists of small molecule product candidates that target cancer.

The company’s lead product candidate is Tipifarnib, an oral farnesyl transferase inhibitor that is in Phase II clinical trials for the treatment of solid tumors, peripheral T-cell lymphomas, myelodysplastic syndromes, acute myeloid leukemia, and chronic myelomonocytic leukemia.

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.

It is also developing KO-947, a small molecule inhibitor of extracellular signal related kinase used for the treatment of patients with tumors that have mutations in, or other dysregulation of, the mitogen-activated protein kinase; and KO-539, a small molecule inhibitor of the menin-mixed lineage leukemia.

The company was founded in 2014 and is headquartered in San Diego, California.

 

Near Perfect

We started off by noting that KURA just hit the wires with the announcement of preliminary data in angioimmunoblastic T-cell lymphoma (AITL) and CXCL12+ peripheral T-cell lymphoma (PTCL), the two expansion cohorts in its Phase 2 clinical trial of its lead drug candidate tipifarnib in patients with relapsed or refractory PTCL.

The stock is up on the news. Overall, shares of KURA have rallied about 13% over the past week. That sets up an interesting context for the action tomorrow.

“The mechanism of action of farnesyl transferase inhibitors has remained elusive for several decades,” said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. “Our initial data in HRAS mutant head and neck cancer provided strong evidence of activity in tumors driven by this oncogene. However, many other tumors such as T- and B-cell lymphomas, myeloid leukemias, pancreatic or breast cancers, in which anecdotal evidence of tipifarnib activity has been reported, do not usually carry HRAS mutations. We believe the preliminary results reported at ASH validate our observation that the CXCL12 pathway is a therapeutic target of tipifarnib and provide a potential path to expand the development of tipifarnib well beyond HRAS mutant solid tumors by using CXCL12-related biomarkers to enrich for patients most likely to benefit from treatment. We will continue our efforts to identify these patient subsets and to bring this important drug candidate to patients in need.”

Kura Oncology Inc (NASDAQ:KURA) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($187.4M against $12.9M).

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