Kura Oncology Partners with Kyowa Kirin for AML Therapy Development

The deal provides Kura with a $330 million upfront payment and up to $1.161 billion in potential milestone payments.

Kura Oncology has announced a global collaboration with Kyowa Kirin to develop and commercialize ziftomenib, an investigational oral menin inhibitor, for treating acute myeloid leukemia (AML) and other hematologic malignancies. 

The deal provides Kura with a $330 million upfront payment and up to $1.161 billion in potential milestone payments.

The agreement includes $420 million in near-term milestone payments, such as those tied to the therapy’s launch in the monotherapy relapsed/refractory AML setting. Potential payments cover development, regulatory, and commercial milestones.

Kura will develop and manufacture the drug in the US, while Kyowa Kirin will oversee efforts outside the US. Kura will receive tiered double-digit royalties on global net sales. Based on a joint commercialization plan, both companies will share profits and losses equally in the US.

Kyowa Kirin retains an option to develop ziftomenib for gastrointestinal stromal tumors (GIST) and other solid tumors, potentially paying Kura $228 million in milestone payments after reviewing clinical data from proof-of-concept studies.

Development Milestones

Kura is conducting trials combining ziftomenib with existing treatments for newly diagnosed and relapsed/refractory AML patients with NPM1 mutations or KMT2A rearrangements. Registrational Phase III trials for frontline AML patients are set to begin in 2025 for fit and unfit groups.

The partnership outlines plans for multiple Phase II and Phase III studies across AML and other hematologic malignancies. Kura will fund development costs until 2028, after which the expenses will be equally shared.

BofA Securities served as Kura’s financial advisor for the transaction, with Cooley providing legal representation.

Kura Oncology CEO and President Troy Wilson stated, “This collaboration is an important step toward fulfilling Kura’s commitment to realize the promise of precision medicines for the treatment of cancer, and it substantially advances our goal of building a sustainable, fully integrated biopharmaceutical company.”

In addition to the collaboration, Kyowa Kirin acquired Orchard Therapeutics in January 2024 for $477.6 million.