Kura Oncology and Kyowa Kirin partner to advance AML treatment

Kura Oncology has entered into a significant global partnership with Kyowa Kirin to develop and commercialize oral ziftomenib, a promising investigational menin inhibitor. This collaboration aims to address acute myeloid leukemia (AML) and other haematologic malignancies with a novel therapeutic approach.

As part of this strategic agreement, Kura Oncology will receive an upfront payment of $330 million and is eligible for up to $420 million in near-term milestone payments, particularly upon the therapy's launch in the monotherapy relapsed/refractory (R/R) setting. Additionally, Kura stands to gain up to $741 million in development, regulatory, and commercial milestone payments, potentially bringing the total financial benefits to $1.161 billion, including an opt-in provision for solid tumors.

Kura will be primarily responsible for the development, regulatory strategies, and manufacturing of ziftomenib within the United States. The two companies will share commercial responsibilities in the US based on a joint territory plan, with profits and losses being equally distributed.

Kyowa Kirin will oversee the development and commercialization efforts outside the United States. Kura Oncology will benefit from tiered double-digit royalties on net sales from these markets.

Currently, Kura is conducting clinical trials to evaluate the efficacy of ziftomenib in combination with existing treatments for newly diagnosed and relapsed/refractory NPM1-mutant and KMT2A-rearranged AML. Phase III registrational studies are anticipated to commence in 2025 for both fit and unfit frontline AML patients.

The partnership between Kura and Kyowa Kirin includes shared responsibilities for clinical trials following a mutually agreed-upon global development plan. Kura will bear the development costs until the end of 2028, after which both companies will share these costs equally. The collaboration agreement also outlines plans to initiate several Phase II and Phase III trials of ziftomenib in AML and other hematologic malignancies in the coming years.

A shared governance structure will be established to manage the development and commercialization activities under this partnership.

Kyowa Kirin retains an option to extend their involvement to include the development and commercialization of ziftomenib for gastrointestinal stromal tumors (GIST) and other solid tumor indications. If Kyowa Kirin opts in after reviewing clinical data from ongoing proof-of-concept studies, Kura Oncology may receive up to $228 million in upfront and milestone payments.

BofA Securities provided advisory services to Kura Oncology during this transaction, with legal representation by Cooley.

Troy Wilson, CEO and president of Kura Oncology, expressed enthusiasm about the partnership, stating, "This collaboration is an important step toward fulfilling Kura's commitment to realizing the promise of precision medicines for the treatment of cancer, and it substantially advances our goal of building a sustainable, fully integrated biopharmaceutical company."

In January 2024, Kyowa Kirin completed the acquisition of Orchard Therapeutics for $477.6 million. This acquisition further highlights Kyowa Kirin's strategic efforts to strengthen its position in the biopharmaceutical industry and expand its portfolio of innovative therapies.