LA JOLLA, Calif.—2015 is off to a busy start for Kura Oncology Inc., as the company capped off the first quarter of the year with the announcement of a new partnership as well as several promising financial events.
Kura announced in March that it had established an agreement with Janssen Pharmaceutica NV for an exclusive license to develop and commercialize Kura’s tipifarnib, a Phase 2-ready program, in oncology. Per the agreement, Kura Oncology will be responsible for developing and commercializing tipifarnib in oncology, and the company plans to move the compound into Phase 2 clinical trials this year to investigate its activity in patients with certain solid tumors driven by mutations of the oncogene HRAS and patients with hematologic malignancies.
Janssen also has a first right to negotiate for an exclusive license back from Kura, says Troy Wilson, president and CEO of Kura Oncology. In addition, he says, Kura “issued a convertible promissory note in the principal amount of $1 million to Johnson & Johnson Innovation-JJDC Inc., which automatically converted into shares of Kura common stock in the private placement. We will make potential success-based development and commercial milestone payments, in addition to tiered royalties of potential net sales.”
Wilson says this is the first time the two companies have worked together, and calls the opportunity presented by tipifarnib “compelling.”
“We were able to convince Janssen that we were best positioned to create value with tipifarnib using new technologies such as next-generation sequencing and a patient-selection strategy, and we worked out a business arrangement where Janssen retained an ROFN [right of first negotiation] on the program, which gives them access to the clinical data and a seat at the table,” he explains. “Janssen has really been a great partner—it’s a credit to them that they were willing to out-license tipifarnib and enable Kura Oncology to work to bring benefit to patients.”
Tipifarnib is a protein farnesyl transferase inhibitor, and farnesylation is a key signaling process implicated in the initiation and development of cancer. In clinical trials, tipifarnib has demonstrated durable anticancer activity in select cancer patient populations, as well as a well-established safety profile. Kura Oncology hopes to begin a Phase 2 trial evaluating tipifarnib in patients whose tumors present with HRAS mutations in the second quarter of this year, and another Phase 2 trial in patients with peripheral T cell lymphomas in the third quarter.
Kura has also announced the completion of a private placement of common stock to new institutional and existing investors, which netted gross proceeds of approximately $60 million, including roughly $7.5 million in bridge notes that converted into common stock at the closing. EcoR1 Capital took point as the lead investor in the financing, which included Fidelity Management & Research Co., ARCH Venture Partners, Boxer Capital of Tavistock Life Sciences, Partner Fund Management, Nextech Invest and other well-known healthcare investors. Leerink Partners LLC was lead placement agent, with National Securities Corporation, a wholly owned subsidiary of National Holdings Inc., and Livingston Securities LLC serving as co-placement agents.
Concurrent with its private placement, Kura also completed a reverse merger with Zeta Acquisition Corp. III, a public reporting company with no previous business operations. Kura’s stockholders received shares of Zeta Acquisition in exchange for their Kura Oncology shares, and the former Kura shareholders now hold 100 percent of the resulting company’s equity in the same proportion as they owned immediately following the private placement. Zeta Acquisition has now been renamed Kura Oncology Inc., and will implement Kura Oncology’s pre-merger business plan. Kura Oncology expects 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.
“The private placement and reverse merger with Zeta accomplish our objectives to recruit an outstanding syndicate of investors and to recruit the capital needed both to fund the Phase 2 development of tipifarnib and to advance our preclinical programs,” Wilson tells DDNews.
Kura is also seeing progress from another of its pipeline programs. At the end of March, a study was published by University of Michigan researchers in Cancer Cell detailing that preclinical compounds from Kura’s menin-MLL inhibitor program had shown promising activity in terms of blocking leukemia progression.
When the menin protein interacts with mixed lineage leukemia (MLL) fusion proteins, it results in MLL leukemias, which comprise approximately 5 to 10 percent of acute leukemias in adults and roughly 70 percent of acute leukemias in infants. MLL leukemias are an aggressive subtype of acute lymphocytic leukemia and acute myeloid leukemia, two of the most common forms of acute leukemia, and patients with these leukemias face extremely poor outcomes with current therapies—at present, only about one-third of patients survive five years after diagnosis.
Kura Oncology began an exclusive license agreement with the University of Michigan in 2014 to access intellectual property and technology related to a class of small-molecule inhibitors that target menin-MLL and could treat acute leukemias, among other cancers. The compounds and technology were developed in the labs of Dr. Jolanta Grembecka and Dr. Tomasz Cierpicki.