The agreement will give Kura enough capital to support the development and launch of its menin inhibitor ziftomenib.
Kura Oncology on Wednesday inked a global strategic collaboration with Kyowa Kirin to advance its oral menin blocker ziftomenib for the treatment of acute myeloid leukemia.
The news comes days after Syndax brought the first menin inhibitor to the market with the FDA’s approval of Revuforj (revumenib). The drug is indicated for patients with relapsed or refractory acute leukemia (R/R AML) harboring a translocation mutation in the lysine methyltransferase 2A (KMT2A) gene.
Under the terms of its deal with Kyowa, Kura will get $330 million upfront and is in line for up to $420 million in near-term milestone payments. The Japanese pharma has also pledged up to $741 million in additional development, regulatory and commercial milestones. All told, Wednesday’s agreement has a maximum aggregate value of $1.161 billion.
Kura will lead ziftomenib’s development in the U.S., as well as all relevant regulatory activities and commercial strategy. The cancer-focused biotech will also be responsible for manufacturing ziftomenib. Kyowa and Kura will jointly commercialize ziftomenib and equally share in potential profits or losses. Kyowa will take charge of the asset outside the U.S., with Kura being eligible to tiered double-digit royalties on net sales.
In a statement, Kura CEO Troy Wilson called Wednesday’s agreement “an important step forward” for the biotech and its mission to realize “the promise of precision medicines for the treatment of cancer.” Kyowa’s upfront payment and anticipated milestones, along with Kura’s current cash position, “should provide sufficient funding to support the ziftomenib program to commercialization in the frontline setting,” a market opportunity that could reach up to $3 billion per year in the U.S., Wilson added.
Investors do not seem to share Wilson’s optimism, however. Kura plunged 17% in after-hours trading following the announcement of the collaboration, according to SeekingAlpha.
Designed to be taken orally, ziftomenib works by targeting menin and disrupting its interaction with the KMTA2 protein. In healthy conditions, menin plays a cancer-suppressing role. However, many patients with leukemia carry translocation mutations in the KMT2A gene, which produces a fusion protein that, when bound to menin, leads to the development of leukemia.
Kura is advancing ziftomenib for the treatment of R/R AML patients with a mutation in the NPM1 gene, which is known to be associated with poor outcomes. The biotech has completed enrollment patients in a registration-directed Phase II study in this indication, for which a New Drug Application is scheduled next year. Kura is also assessing ziftomenib as an add-on therapy to current standards of care in newly diagnosed R/R AML patients with NPM1 mutations and KMT2A rearrangements.
