The partnership involves commercialising and developing the therapy for treating acute myeloid leukaemia and other hematologic malignancies. Credit: Rachaphak/Shutterstock.

Kura Oncology has partnered Kyowa Kirin in a strategic global collaboration to develop and commercialise oral ziftomenib, an investigational menin inhibitor, to treat acute myeloid leukaemia (AML) and other haematologic malignancies.

Kura will receive a $330m upfront payment and up to $420m in near-term milestone payments, including when the therapy launches in the monotherapy relapsed/refractory (R/R) setting.

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Kura may also earn up to $741m in development, regulatory and commercial milestones, bringing the total potential payments to $1.161bn, including the opt-in for solid tumours.

Kura will spearhead the development, regulatory strategies and manufacturing of ziftomenib in the US.

The companies will partner on commercial activities based on a joint US territory plan, sharing profits and losses equally.

Kyowa Kirin will lead development and commercialisation outside the US, with Kura receiving tiered double-digit royalties on net sales.

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Kura is also conducting trials to assess ziftomenib in conjunction with current standards of care for newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML.

Registrational Phase III frontline studies are expected to begin in 2025 for both fit and unfit frontline AML patients.

The partnership includes shared responsibilities for clinical trials within an agreed-upon worldwide development plan.

Kura will fund costs for the development until 2028-end, after which they will be shared equally. The agreement also outlines plans to introduce several Phase II and Phase III trials of ziftomenib in AML and other haematologic malignancies in the upcoming years.

A shared governance structure will manage development and commercialisation activities.

Kyowa Kirin retains an option to join ziftomenib’s development and commercialisation for gastrointestinal stromal tumours (GIST) and other solid tumour indications, with potential upfront and milestone payments to Kura totalling $228m upon opting in after clinical data from ongoing proof-of-concept studies.

BofA Securities advised Kura in the transaction, with representation by Cooley.

Kura oncology CEO and president Troy Wilson stated: “This collaboration is an important step toward fulfilling Kura’s commitment to realise 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 January 2024, Kyowa Kirin completed the acquisition of Orchard Therapeutics for $477.6m.