A cancer drug developer startup founded by former Intellikine CEO Troy Wilson said today it has exclusively licensed development and commercialization rights from Johnson & Johnson’s Janssen Pharmaceutica to its Phase II-ready lead compound tipifarnib in oncology indications.
Kura Oncology said it will assume sole responsibility for development and commercialization of tipifarnib for cancer indications, with plans to advance the protein farnesyl transferase inhibitor (FTI) into Phase II clinical trials later this year.
The trials will be designed to evaluate tipifarnib’s activity in patient populations where some solid tumors are driven by activating mutation in the oncogene HRAS, as well as in patients with hematologic malignancies, Kura Oncology said.
Tipifarnib has failed clinical trials in which the compound had been indicated for advanced pancreatic cancer and elderly adults with newly-diagnosed acute myeloid leukemia. While tipifarnib has demonstrated encouraging clinical activity in other cancer patient populations, the company added, “that may be further optimized using an appropriate patient selection strategy.”
Kura Oncology is the second company in three months to license tipifarnib from Janssen. In December 2014, the EB Pharma subsidiary of Eiger BioPharmaceuticals inked an exclusive license to the compound and a related, clinical stage back-up compound for the field of virology. EB Pharma said it was conducting clinical studies in patients infected with hepatitis delta virus (HDV), with plans to assess the efficacy and tolerability of tipifarnib as a potential new therapy.
In cancer, according to Kura Oncology’s website, tipifarnib is being developed in part as a treatment for advanced tumors with a known HRAS mutation, since the compound has been shown to inhibit HRAS function. By blocking HRAS farnesylation and subsequent membrane localization, tipifarnib inhibits oncogenic, HRAS-driven cellular transformation in vitro and in vivo.
Tipifarnib is also in development against peripheral T-cell lymphoma (PTCL), a group of rare and usually aggressive forms of non-Hodgkin lymphoma that develop from mature T-cells. A Phase II trial of tipifarnib in adults with relapsed or refractory lymphoma, conducted at the Mayo Clinic, showed that tipifarnib can be administered for prolonged periods and may produce durable responses as a single agent in relapsed lymphoma in patients pretreated with a median of five prior therapies.
Kura Oncology plans to launch a Phase II clinical trial of tipifarnib in patients with tumors characterized by HRAS mutations in the second quarter. That will be followed in the third quarter by a separate Phase II clinical trial in patients with peripheral T-cell lymphomas.
To fund development of tipifarnib and other company drug candidates, including preclinical pipeline programs. Kura Oncology completed a $60 million private placement of its common stock to new institutional investors and existing investors. The proceeds included about $7.5 million in bridge notes that were converted into common stock at the closing.
Lead investor for the private placement was EcoR1 Capital, with what the company called “significant” participation from investors that included Fidelity Management & Research Company, ARCH Venture Partners, Boxer Capital of Tavistock Life Sciences, Partner Fund Management, Nextech Invest, and several undisclosed “well-known healthcare investors.”
In conjunction with the private placement, Kura Oncology completed a reverse merger with the public reporting company Zeta Acquisition Corp III. Kura Oncology stockholders, including participants in the private placement, received shares of Zeta Acquisition in exchange for their Kura shares, while former Kura stockholders now hold 100% of the resulting company’s equity in the same proportion as the stockholders owned immediately following the private placement.
Zeta Acquisition has been renamed Kura Oncology, with plans to implement the company’s pre-reverse merger business plan. The new Kura Oncology intends to file a registration statement covering the resale of shares of common stock held by new and existing shareholders within 60 days after the closing. Once that registration statement takes effect, Kura Oncology said, it will seek to have its common stock traded publicly on the OTC Markets.
In addition to its clinical programs for tipifarnib, Kura Oncology’s pipeline includes compounds designed to inhibit the activity of extracellular-signal-regulated kinases 1 and 2 (ERK1/2). These include lead candidate KO-947—now in IND-enabling preclinical studies—and backup compounds, which are being developed as potential treatments for patients with tumors that have mutations in or other dysregulation of the mitogen-activated protein kinase (MAPK) signaling pathway, including mutations in the proteins KRAS, BRAF, and NRAS.
The company is also in preclinical phases of advancing orally available, small molecule compounds designed to inhibit the interaction between the proteins menin and mixed-lineage leukemia (MLL) for the treatment of MLL-rearranged leukemias. The menin MLL inhibitor program is now in the lead optimization stage, Kura Oncology said.
Wilson headed Intellikine until it was acquired by Takeda America in 2011 for $190 million upfront plus $110 million in clinical development milestones.