Kura Oncology has entered into a global strategic collaboration with Kyowa Kirin, receiving $330 million upfront to advance the development and commercialization of ziftomenib, a menin inhibitor, for the treatment of acute leukemias. The collaboration aims to address the unmet need for effective therapies in patients with leukemias driven by KMT2A gene mutations.
Ziftomenib: A Potential Treatment for KMT2A-Driven Leukemias
Ziftomenib has completed a Phase 2 trial and is being prepared for an FDA submission in 2025 as a treatment for advanced acute myeloid leukemia (AML). The drug is designed to block menin, a protein that interacts with KMT2A fusion proteins to drive disease progression in patients with leukemia characterized by KMT2A genetic rearrangements. These aggressive leukemias are often prone to relapse and drug resistance.
Collaboration Details and Future Development
Under the agreement, Kura Oncology will lead development and commercialization efforts in the U.S., while Kyowa Kirin will have exclusive commercialization rights in the rest of the world. The two companies will share profits equally in the U.S. Kura is eligible for up to $1.2 billion in milestone payments, with $420 million tied to the launch of ziftomenib in advanced AML. The collaboration also grants Kyowa Kirin opt-in rights to develop and commercialize ziftomenib in gastrointestinal stromal tumors and other solid tumors, potentially triggering an additional $228 million in milestone payments. Plans are underway for two placebo-controlled Phase 3 studies evaluating ziftomenib as a first-line treatment for AML driven by either KMT2A or NPM1 mutations, expected to begin in mid-2025.
Analyst Perspective
Leerink Partners analyst Jonathan Chang views the collaboration positively, noting that it provides Kura Oncology with the necessary resources to aggressively pursue the broad development and commercialization of ziftomenib. Chang also highlighted ziftomenib as a promising agent in the emerging class of menin-MLL inhibitors.
Kura Oncology's Broader Pipeline
In addition to ziftomenib, Kura Oncology is developing tipifarnib, a farnesyl transferase inhibitor, for certain head and neck squamous cell carcinomas. A Phase 1/2 study is evaluating tipifarnib in combination with Novartis’s Piqray, a PI3K pathway inhibitor approved for breast cancer driven by PI3K mutations. Data from this study is expected to be presented at a medical meeting in the first half of next year.
