US-based Kura Oncology, Inc. (NASDAQ: KURA) has entered into a licensing deal with Japan-headquartered Kyowa Kirin Co., Ltd. (TYO: 4151), granting Kyowa Kirin exclusive commercialization rights to Kura’s menin inhibitor ziftomenib outside of the United States. Kura retains the corresponding rights within the US.
Financial Terms and Milestones
According to the agreement, Kura will receive an upfront payment of USD 330 million and is expected to be eligible for up to USD 420 million in near-term milestone payments, including a payment upon the launch of ziftomenib in the monotherapy relapsed/refractory (R/R) setting. Furthermore, Kura is in line to receive additional development, regulatory, and commercial milestone payments of USD 741 million, totaling up to USD 1.161 billion for milestones and opt-in for solid tumor indications. For the global development plan, Kura will cover the development costs until the end of 2028, after which the costs will be equally shared starting from 2029.
Development and Commercialization Options for GIST and Solid Tumors
Kyowa Kirin also holds an option to participate in the development and commercialization of ziftomenib in gastrointestinal stromal tumors (GIST) and other solid tumor indications upon opt-in after receiving clinical data from an ongoing proof-of-concept study. This study is evaluating ziftomenib and imatinib in patients with advanced GIST not successfully treated with imatinib. Should Kyowa Kirin exercise its option, Kura would be eligible for upfront and milestone payments totaling USD 228 million, with the collaboration structure mirroring that of AML and other heme malignancies.
Ziftomenib’s Breakthrough Therapy Designation and Upcoming NDA Filing
Ziftomenib is the first and only investigational therapy to receive Breakthrough Therapy Designation (BTD) from the FDA for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). With a Phase II clinical study in R/R NPM1-mutant AML completed, the drug is on track for a New Drug Application (NDA) filing in the following year.-Fineline Info & Tech
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