Kura Oncology and Kyowa Kirin Form Global Partnership for Ziftomenib in Acute Leukemias

Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. have formed a global strategic partnership to advance and commercialize ziftomenib, an oral treatment targeting menin inhibitors, which is currently being researched for acute myeloid leukemia (AML) and other hematologic cancers.

Under the agreement, Kura will receive an upfront payment of $330 million and expects to gain up to $420 million in near-term milestone payments, notably including a payment upon the launch of ziftomenib for monotherapy in relapsed/refractory (R/R) settings. Additionally, Kura may receive further development, regulatory, and commercial milestone payments amounting to $741 million. This brings the total potential milestone payments to up to $1.161 billion, including the opt-in for solid tumor indications.

In the U.S., Kura will handle development, regulatory, and commercial strategies, as well as manufacturing responsibilities for ziftomenib. The companies will share commercialization efforts and profits equally in the U.S. Outside of the U.S., Kyowa Kirin will lead these activities, and Kura will receive tiered double-digit royalties on net product sales.

Kyowa Kirin, a global pharmaceutical company based in Japan, aims to deliver transformative treatments and has committed to leveraging its expertise in hemato-oncology to bring ziftomenib to market. Yasuo Fujii, Chief Strategy Officer of Kyowa Kirin, expressed optimism about ziftomenib's potential to enhance outcomes for genetically defined AML patients and expand Kyowa Kirin’s oncology portfolio.

Ziftomenib holds a breakthrough designation from the U.S. Food and Drug Administration (FDA) for treating R/R NPM1-mutant AML, a mutation linked to poor outcomes. Kura has completed enrollment for a Phase 2 trial aimed at registration and plans to submit a New Drug Application (NDA) in 2025. The company is also running trials to test ziftomenib in combination with current standards of care for both newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Registrational Phase 3 studies are expected to begin in 2025.

Kura's CEO, Troy Wilson, highlighted the significance of this collaboration in advancing Kura's mission to develop precision medicines for cancer treatment. He praised Kyowa Kirin as an ideal partner, bringing substantial expertise and global reach to the collaboration. He also noted that the financial aspects of the partnership, along with Kura’s current cash reserves, should fund the development of ziftomenib through commercialization.

Following regulatory approval, Kura will lead U.S. commercial strategy and book sales, with both companies sharing commercialization activities and profits equally in the U.S. Outside the U.S., Kyowa Kirin will lead commercialization activities and Kura will receive royalties on sales.

The partnership includes a global development plan for ziftomenib, with Kura funding development costs through 2028. From 2029 onwards, both companies will share development costs equally. They plan to launch multiple Phase 2 and Phase 3 studies for AML and other hematologic malignancies.

Kyowa Kirin also has the option to join the development and commercialization of ziftomenib for gastrointestinal stromal tumors (GIST) and other solid tumors. If they opt in, Kura could receive upfront and milestone payments totaling $228 million, with a similar collaborative structure to their AML efforts.

Kura was advised by BofA Securities and represented by Cooley LLP in the transaction.

About Kura Oncology: Kura is a clinical-stage biopharmaceutical company committed to developing precision medicines for cancer treatment, with a pipeline including ziftomenib and other drug candidates targeting cancer signaling pathways.

About Kyowa Kirin: Kyowa Kirin is a global specialty pharmaceutical company focused on innovative drug discovery and biotechnology, aiming to provide transformative treatments for patients with unmet medical needs.