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Kura Oncology and Kyowa Kirin Forge Global Partnership to Develop and Commercialize Ziftomenib for Acute Myeloid Leukemia

NextEdge Admin

23 Nov 2024

2 min 15 sec

Kyowa Kirin Co., Ltd.,collaboration,AML,Oncology

Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced a global collaboration to develop and commercialize ziftomenib, a selective oral menin inhibitor being investigated for acute myeloid leukemia (AML) and other hematologic malignancies.

Under the agreement, Kura will receive $330 million upfront and up to $420 million in near-term milestone payments, with potential additional payments totaling $1.161 billion, including an opt-in for solid tumor indications. Kura will lead development and commercialization in the U.S., sharing profits and losses equally with Kyowa Kirin, while Kyowa Kirin will oversee these efforts outside the U.S. and pay tiered double-digit royalties on sales.

Kyowa Kirin, leveraging its hemato-oncology expertise, aims to bring ziftomenib to market globally. Yasuo Fujii, Chief Strategy Officer of Kyowa Kirin, noted the therapy's potential for improving outcomes in genetically defined AML patients and complementing the company’s oncology portfolio.

Ziftomenib is the first investigational therapy with FDA breakthrough designation for relapsed/refractory NPM1-mutant AML, a mutation linked to poor outcomes. Enrollment in a Phase 2 trial is complete, with an NDA submission expected in 2025. Kura plans Phase 3 frontline studies for newly diagnosed AML patients that year.

Kura CEO Troy Wilson emphasized the collaboration’s significance in advancing precision cancer therapies and supporting ziftomenib’s commercialization, estimating the U.S. frontline AML market at $3 billion annually. This partnership, he said, positions Kura as a fully integrated biopharmaceutical company.