Kura Oncology Partners With Kyowa Kirin To Develop Ziftomenib For Acute Leukemias; Stock Drops

(RTTNews) - Kura Oncology Inc. (KURA) said that it has entered into a global strategic collaboration with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib, Kura's selective oral menin inhibitor, being investigated for the treatment of patients with acute myeloid leukemia (AML) and other hematologic malignancies.

KURA closed Wednesday's regular trading at $15.91 down $0.05 or 0.31%. In the after-hours trading, the stock further dropped $1.66 or 10.43%.

As per the terms of the agreement, Kura will receive an upfront payment of $330 million and expects to receive up to $420 million in near-term milestone payments, including a payment upon the launch of ziftomenib in the monotherapy relapsed/refractory (R/R) setting.

In addition, Kura is eligible to receive additional development, regulatory and commercial milestone payments of $741 million, totaling up to $1.161 billion in payments for milestones and the opt-in for solid tumor indications.

In the U.S., Kura will lead development, regulatory and commercial strategy and be responsible for manufacturing ziftomenib. The companies will jointly perform commercialization activities in accordance with a co-created U.S. territory commercialization plan and will share equally in any potential profits and losses.

Outside the U.S., Kyowa Kirin will lead development, regulatory and commercial strategy and is responsible for commercializing ziftomenib. Kura will be eligible to receive tiered double-digit royalties on net product sales.

As part of the strategic collaboration, the companies will share responsibility for the conduct of clinical trials delineated within an agreed-upon global development plan.

For the global development plan, Kura will fund the development costs until the end of 2028, and from 2029 onwards, both companies will share the costs at a 50:50 ratio. The companies will share equally the funding of future trials in the U.S. The agreement includes plans to launch multiple Phase 2 and Phase 3 studies of ziftomenib in AML and other hematologic malignancies over the next several years. Development and commercialization activities under the collaboration will be managed through a shared governance structure.

Under the Agreement, Kyowa Kirin has 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 receipt of clinical data from the ongoing proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST not successfully treated with imatinib.

If Kyowa Kirin exercises its option, Kura is eligible for upfront and milestone payments totaling $228 million and the parties' roles and responsibilities follow the same structure as the collaboration in AML and other heme malignancies. Excluded from the collaboration are Kura's ongoing efforts to advance multiple, next-generation menin inhibitor drug candidates targeting certain oncology indications, as well as diabetes and other metabolic diseases.