**Kura Oncology, Inc., a biopharmaceutical company specializing in clinical-stage drug development, and Kyowa Kirin Co., Ltd., an international specialty pharmaceutical firm, have announced a global partnership.** The agreement focuses on developing and marketing ziftomenib, Kura’s selective oral menin inhibitor, currently under investigation for treating acute myeloid leukemia (AML) and other hematologic conditions.
**As part of the deal, Kura will receive an upfront sum of $330 million, plus potential near-term milestone payments of $420 million.** These include payouts upon launching ziftomenib for relapsed/refractory (R/R) AML in a monotherapy setting. Additionally, Kura stands to gain further development, regulatory, and commercial milestone payments amounting to $741 million, with potential earnings totaling $1.161 billion when including opt-ins for solid tumor indications.
**In the United States, Kura will spearhead the development, regulatory, and commercial pathways and manage ziftomenib manufacturing.** The partners will jointly execute commercialization strategies as per a mutually developed US territory plan, with potential profits and losses shared equally.
**Kyowa Kirin will take the lead outside the US, focusing on development, regulatory, and commercial strategy for ziftomenib.** The company will manage marketing efforts, while Kura will earn tiered double-digit royalties from net sales of the product.
**Kyowa Kirin’s goal is to deliver meaningful therapies that improve the lives of individuals living with diseases.** By utilizing their expertise in haemato-oncology and prioritizing collaborations, the company aims to globally bring ziftomenib to market effectively.
**”We view ziftomenib as an exciting treatment option for genetically specific AML patients,” commented Yasuo Fujii, Chief Strategy Officer at Kyowa Kirin.** “The addition of ziftomenib aligns with Kyowa Kirin’s hematology portfolio while expanding our focus on combination therapies promising enhanced results for cancer patients. Collaborating with Kura enriches our oncology lineup, aligned with our commitment to introducing cutting-edge treatment options worldwide.”
**Ziftomenib is the sole investigational therapy designated as a breakthrough by the FDA for treating R/R NPM1-mutant AML, a mutation linked to unfavorable outcomes.** Enrollment for a phase 2 registration trial in this AML subtype is complete, with an NDA submission anticipated in 2025. Kura is probing ziftomenib’s efficacy in combination with standard care for newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML patients. The company intends to start phase 3 frontline studies later this decade.
**”This partnership brings us closer to realizing precision medicine’s potential for cancer treatment,” said Troy Wilson, CEO of Kura Oncology.** “Our collaboration with Kyowa Kirin enhances Kura’s vision of a sustainable, integrated biopharma company. Together, we aim to unlock ziftomenib’s transformative capabilities for AML patients.”
**In the US, following regulatory endorsement, Kura will drive commercial strategy development.** The venture anticipates equal sharing of profits and losses from commercialization pursuits. Kyowa Kirin takes charge of similar functions outside the US, with Kura entitled to royalties from sales.
**Under the partnership, both companies will collectively manage clinical trials as detailed in an agreed global development plan.** Kura funds development through 2028, with shared costs beginning in 2029. The plan includes several phase 2 and 3 trials for AML and related hematologic diseases, overseen by a joint governance structure.
**The agreement grants Kyowa Kirin an option to participate in ziftomenib’s development and marketing for gastrointestinal stromal tumors (GIST) and other solid tumors.** Pending clinical results from an ongoing study of ziftomenib with imatinib in advanced GIST cases, if Kyowa Kirin elects to proceed, Kura is set to receive payments totaling $228 million. Excluded are Kura’s projects in next-gen menin inhibitors for certain cancer and metabolic diseases.
**Kura was advised by BofA Securities and represented by Cooley LLP in this transaction.**
**Ziftomenib targets AML patients with genetic specificities, receiving FDA Breakthrough Therapy signals thanks to promising data from Kura’s KOMET-001 trial.** This collaboration signifies Kura’s dedication to leveraging precision medicine for combating cancer, with a pipeline rich in small molecule drug candidates addressing cancer signaling pathways.
**Kyowa Kirin has a long-standing history of developing innovative drugs, aiming to offer groundbreaking treatments for complex conditions.** The company’s expansive approach includes next-gen antibodies, and cell and gene therapies for unmet needs in hematology and rare diseases.