Japan-based Kyowa Kirin is fronting $330 million and pledging up to $1.1 billion in milestones to split the U.S. profits of Kura Oncology’s phase 2-stage oral leukemia treatment as well as to secure the commercialization rights for the rest of the world.
The asset in question, ziftomenib, is a selective oral menin inhibitor currently undergoing a midstage study in relapsed or refractory NPM1-mutated acute myeloid leukemia (AML), among other studies. Kura has also been preparing to launch phase 3 trials in 2025 in various AML populations, the same year that it hopes to submit an approval application to the FDA.
As well as the upfront cash, Kyowa has also signed off on up to $420 million in near-term milestone payments. This could be followed by up to $741 million in additional development, regulatory and commercial milestone payments, which include an opt-in to develop ziftomenib in gastrointestinal stromal tumors and other solid tumor indications.
This money should fund ziftomenib through to commercialization as a front-line AML treatment, said Kura CEO Troy Wilson, Ph.D., who anticipates a potential $3 billion annual market in the U.S. alone.
The two companies will share responsibility for launching a range of phase 2 and 3 trials in AML and other blood cancers “over the next several years,” with Kura funding development of ex-U.S. trials until the end of 2028, after which point the biotechs will split the costs, as they will already be doing in the States.
Kura will take the lead in the U.S. for regulatory and commercial strategy as well as manufacturing. Kyowa will be in charge for all other territories, with Kura in line for tiered double-digit royalties on sales.
“The addition of ziftomenib will complement Kyowa Kirin’s existing hemato-oncology portfolio and pipeline and expand our clinical development efforts into combination therapies designed to generate improved outcomes for cancer patients,” Kyowa Chief Strategy Officer Yasuo Fujii said in the release
Kura kicked off the year posting fresh phase 1b data suggesting ziftomenib performed best on top of a standard-of-care combo regimen in newly diagnosed patients with specific mutations.