Kura flashes positive HRAS data on once-failed J&J drug
Troy Wilson was working with J&J on their KRAS inhibitor and periodically thumbing through their publications when he spotted an old drug called tipifarnib that looked promising. So promising, in fact, that the large pharma had run it through over 5,000 patients across 70 trials, hoping they would at some point be able to nail down who were the small slice of patients who responded in some studies.
“They did it the old-fashioned away,” Wilson told Endpoints News. “They threw spaghetti against the wall, and the spaghetti didn’t stick.”
By the early 2010s, though, when Wilson was trawling the Janssen archives, there was next-gen sequencing and molecular methods to identify those patients whose cancers were driven by the protein tipifarnib targeted, HRAS. Wilson asked the J&J scientists why they weren’t doing that. “Yeah it should work,” Wilson recalls them saying, but “Troy, we can’t do everything.”
So the serial biotech executive, who had been working with J&J as CEO of Wellspring Biosciences, licensed the drug away and founded Kura Oncology to push it forward as a targeted drug for cancer patients with HRAS mutations or an over-abundance of HRAS.
Now for the first time in the 15-plus year history of the compound, Kura has evidence that, when given to the right patients, the drug can help patients live longer.
In a release ahead of an ASCO oral presentation, the company reported Phase II data showing that, across 18 patients with HRAS mutant head and neck cancer, the drug had an overall response rate of 50% and led to a median overall survival of 15.4 months. That compares to a median OS of 5-8 months for second-line patients, according to figures cited by the company data. The median patient in the study had already undergone 2 lines of therapy.
Kura had shown in the fall that the drug could shrink tumors, but had yet to show any survival benefit.
“Yes the patient wants to see their tumors shrink, but at the end of the day, the physicians and the patients, what they care most about it is that there’s actually a survival advantage,” Wilson said. “So this is meaningful when you look at the currently approved therapies and it’s meaningful when you think to yourself that survival of 15 months is greater than what you would see in the frontline therapy setting.”
The two adverse events that appeared in more than 10% of patients were cytopenias and GI disturbances. Progression-free survival was 5.9 months.
The company has already begun a registrational trial they hope will lay the basis for an accelerate approval with the FDA, the agency that in 2005 rejected a J&J application to approve the drug for AML.
Social: Troy Wilson, Kura Oncology CEO (Kura via YouTube)