Kura Oncology, Kyowa Kirin to develop and commercialize ziftomenib in leukemias

Kura Oncology (KURA) and Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor, being investigated for the treatment of patients with acute myeloid leukemia – AML – and other hematologic malignancies. Kura will receive an upfront payment of $330M and expects to receive up to $420M in near-term milestone payments, including a payment upon the launch of ziftomenib in the monotherapy relapsed/refractory setting. In addition, Kura is eligible to receive additional development, regulatory and commercial milestone payments of $741M, totaling up to $1.161B in payments for milestones and the opt-in for solid tumor indications. In the U.S., Kura will lead development, regulatory and commercial strategy and be responsible for manufacturing ziftomenib. The companies will jointly perform commercialization activities in accordance with a co-created U.S. territory commercialization plan and will share equally in any potential profits and losses. Outside the U.S., Kyowa Kirin will lead development, regulatory and commercial strategy and is responsible for commercializing ziftomenib. Kura will be eligible to receive tiered double-digit royalties on net product sales.Ziftomenib is the first and only investigational therapy to receive breakthrough designation from the FDA for the treatment of R/R NPM1-mutant AML. The companies anticipate submission of a New Drug Application in 2025. Kura expects to initiate registrational Phase 3 frontline studies in both the fit and unfit frontline AML patient populations in 2025.