Johnson & Johnson has brushed a decade’s worth of dust from the leukaemia project tipifarnib and found some willing buyers. Yesterday Kura Oncology turned its deal for cancer-related rights to the farnesyl transferase inhibitor into a stock market listing and $60m share sale.
Kura plans to advance the agent in HRAS-mutant solid tumours and T-cell lymphoma, based on knowledge about its effect on specific tumour cells built by continuing research at non-commercial institutions. Not every dead drug can be brought to life, of course, but growing understanding of genetic biomarkers is spurring a second look at abandoned programmes.
From stealth to phase II
With the transaction, California-based Kura went from being a preclinical oncology developer to a clinical-stage biotech and instantly began behaving like one. A reverse merger into Zeta Acquisition Corp III will enable it to achieve an OTC market listing, and in the meantime it made a $60m private placement with a number of venture backers.
Supported by phase II data, J&J had submitted tipifarnib to the FDA back in 2005 for elderly patients with acute myeloid leukaemia who are not candidates for standard chemotherapy, but received a not-approvable letter.
After the rejection the company said nothing about tipifarnib, but non-commercial entities like the US National Institutes for Health remained interested in it. The most recent NIH trial began in 2011 in AML with a specific genetic profile estimated to encompass 30% of patients; clinicaltrials.gov lists two active NIH-sponsored trials that have not reached their estimated primary completion dates, and a third was scheduled to end in December 2014.
“It was the right drug at the wrong time,” Thilo Schroeder, a partner at one of Kura's VC backers, Nextech Invest, told EP Vantage.
J&J could show a very strong response in a very small population, but it has only recently been able to identify more specifically which patients will respond, Mr. Schroeder said. “This has been the FDA’s response: show us who is going to respond and we can approve this drug.”
HRAS mutations, in which Kura plans to test tipifarnib, have been implicated in bladder and thyroid cancer, to name two; the work in haematological cancer will also be continued.
J&J has also licensed tipifarnib in virology to Eiger BioPharmaceuticals, further monetising this discarded agent. Eiger’s subsidiary EB Pharma will be testing it in hepatitis D.
Back from the dead
Kura has resisted the allure of the initial public offering and has taken the quick, inexpensive and lower-risk route to the public markets through its reverse merger. In that, it follows the template of Puma Biotechnology, which licensed a forgotten Pfizer project and merged its way into a listing. Kura's chief executive, Troy Wilson, sat on Puma’s board, and also headed Intellikine before that group’s acquisition by Takeda.
Puma has been able to take neratinib and run with it, to great investor accolade – its shares have appreciated an incredible 19-fold since listing. Mr Schroeder does not believe that this will be a common strategy in the future, but says it is one some companies will want to explore.
“There will be some opportunistic cases where a molecule is interesting but it had a lack of biological understanding,” he said. “Once you can understand the biology behind it you can develop this asset in a whole different way that increases the likelihood of success.”
Should Kura manage to repeat Puma’s feat it could inspire more developers to begin poking around the curio shops inside big pharma, looking for hidden treasures.
To contact the writer of this story email Jonathan Gardner in London at firstname.lastname@example.org or follow @ByJonGardner on Twitter