Kura Oncology and Kyowa Kirin Announce Strategic Partnership for Ziftomenib Development in Acute Leukemias
Thursday, November 21, 2024
Kura Oncology and Kyowa Kirin have formed a global collaboration to develop and commercialise ziftomenib, an investigational oral menin inhibitor targeting acute myeloid leukaemia (AML) and other haematologic malignancies.
Ziftomenib is an oral, selective menin inhibitor being developed to treat genetically defined acute myeloid leukaemia (AML) patients with significant unmet needs.
Under the agreement, Kura will receive an upfront payment of $330 million and up to $420 million in near-term milestone payments, including one tied to the launch of ziftomenib in a monotherapy setting for relapsed/refractory (R/R) AML.
Additional payments of $741 million are linked to development, regulatory, and commercial milestones, potentially totalling $1.161 billion. These figures include an opt-in for solid tumour indications.
In the United States, Kura will manage development, regulatory activities, manufacturing, and commercial strategy. Both companies will share responsibilities for commercialisation, with profits and losses evenly distributed.
Outside the US, Kyowa Kirin will lead regulatory and commercial activities, with Kura receiving tiered double-digit royalties on net sales.
Kyowa Kirin, a Japan-based pharmaceutical company, intends to utilise its expertise in haematology-oncology and partnerships to support the global introduction of ziftomenib.
The therapy, which has received breakthrough designation from the US FDA for R/R NPM1-mutant AML, is recognised as a promising treatment option for genetically defined AML patients.
A Phase 2 registration trial for ziftomenib in R/R NPM1-mutant AML has been completed, with a New Drug Application submission anticipated in 2025.
Kura is also conducting studies to evaluate the therapy in combination with existing standards of care and plans to initiate Phase 3 frontline studies for newly diagnosed AML patients, including those deemed fit or unfit for intensive treatment.
This partnership aligns with Kura’s strategic goal to advance precision medicines and establish itself as a fully integrated biopharmaceutical company. The agreement's financial framework is expected to provide adequate funding to progress ziftomenib through commercialisation in frontline AML, a market estimated at $3 billion annually in the US.
The collaboration underscores the potential of ziftomenib to address unmet medical needs in AML and expand treatment options globally.
Source: kuraoncology.com
