(RTTNews) - Kura Oncology, Inc. (KURA), a clinical-stage biopharmaceutical company, on Wednesday, announced a collaboration with Kyowa Kirin Co., Ltd., a Japanese-based pharmaceutical company for the development and commercialization of Ziftomenib.
Ziftomenib, Kura's lead drug candidate, is a selective and oral menin inhibitor currently in development for the treatment of genetically defined acute myeloid leukemia (AML) patients with high unmet need.
A phase II registration-directed trial of Ziftomenib in R/R NPM1-mutant AML is underway, with a New Drug Application expected to be submitted in 2025. Additionally, registrational Phase 3 frontline studies with Ziftomenib in both the fit and unfit frontline AML patient populations are expected to be initiated in 2025.
As part of the agreement, the companies will jointly pursue broad development program with Ziftomenib targeting acute leukemias, including frontline indications, combinations with targeted therapies and post-transplant maintenance setting.
The deal entitles Kura to receive a $330 million upfront payment and up to $1.2 billion in total milestone payments, including $420 million in near-term milestone payments and opt-in right for solid tumor indications.
While Kura will oversee the development and manufacture of Ziftomenib in the U.S., Kyowa Kirin will take the lead in commercialization outside the U.S.
Kura is said to fund the development costs until the end of 2028, and from 2029 onwards, both companies will share the costs at a 50:50 ratio.
KURA closed Wednesday's trading at $15.91, down by 0.31 percent on the Nasdaq.
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