Four years after executing a $310 million deal to sell Intellikine to Takeda, biotech entrepreneur Troy Wilson is back, springing out of stealth mode with a new company that has a full team, $60 million in financing, a cancer drug in-licensed from Johnson & Johnson ($JNJ) and a plan to start mid-stage development with two Phase II studies launching later in the year. And he's done it while working out an OTC listing that puts him in a public market with an eye to moving up to one of the national exchanges.
Kura Oncology has a foothold on both coasts, with offices in La Jolla and Cambridge, MA, where the development team will be based. The bankroll comes from some prominent as well as unnamed investors. EcoR1 Capital was the lead investor in the financing, which included significant participation from Fidelity Management & Research Company, ARCH Venture Partners, Boxer Capital of Tavistock Life Sciences, Partner Fund Management, "as well as a number of other well-known healthcare investors."
Those investors believe Wilson and his colleagues at Kura have figured out something that a long lineup of investigators has so far failed to do: Demonstrate that the drug tipifarnib can prove to be of real value for cancer patients. Over the years the drug has been studied in some 20 clinical trials as investigators puzzled out signs of its activity. It has failed in pancreatic cancer, newly diagnosed acute myeloid leukemia in the elderly and more.
Wilson, though, says that advances in sequencing make it possible to pursue tipifarnib as a treatment for a subset of patients with HRAS mutations, providing a clear pathway for clinical development in a program that has plenty of cash available to complete the two Phase II studies: the first in tumors characterized by HRAS mutations, which starts in the second quarter of 2015, and a second in patients with peripheral T-cell lymphomas that launches in the third quarter of 2015. And Wilson's team can push ahead with an ample set of safety data in hand from previous trials.
"This is a drug that was really developed in a different era," Wilson, a board member at Puma, tells FierceBiotech. "Had it been developed today I think it would have been developed very differently."
While Wilson is quick to acknowledge that J&J has a very active oncology effort and plenty of resources to do this for themselves, he adds that the pharma giant has also expressed its confidence in the staff of 15 at the small biotech, a team that includes CSO Yi Liu and CMO Antonio Gualberto. UCSF's Kevan Shokat chairs the scientific advisory board.
Together, they'll be advancing the Phase II studies while doing their own in-house work on preclinical cancer drug targets. And J&J has a right to engage in first talks for a deal with Kura, which now provides a new vessel for Wilson's considerable ambitions in the field.
"Everyone says they want to create the next Genentech," says Wilson. "I'd like to create the next Onyx, the next Puma or Clovis; companies that quickly created value for targeted subsets of patients in oncology."
- here's the release