Ziftomenib Takes Center Stage in Kura and Kyowa Kirin’s $1.2 Billion Partnership

In a landmark collaboration, oncology innovator Kura Oncology and global pharmaceutical leader Kyowa Kirin have announced a global partnership to develop and commercialize ziftomenib, an investigational therapy targeting acute myeloid leukemia (AML) and other hematologic cancers.

This alliance combines Kura’s precision medicine expertise with Kyowa Kirin’s global reach to bring new hope to patients with limited treatment options.

Ziftomenib is a selective oral menin inhibitor designed to target genetic mutations associated with poor AML outcomes, such as NPM1 mutations. These mutations disrupt normal cellular processes, allowing cancer cells to proliferate unchecked.

By inhibiting menin, ziftomenib aims to restore cellular balance, offering a new approach to tackling these aggressive cancers. Yasuo Fujii of Kyowa Kirin highlighted ziftomenib’s potential to complement the company’s existing hemato-oncology pipeline, positioning it as a promising therapy in combination with current treatments.

Currently, ziftomenib is under evaluation in a Phase II registration-directed trial for relapsed or refractory NPM1-mutant AML, with topline results expected in early 2025.

Adding to its momentum, Kura plans to present updated data from more than 100 patients at the 66th American Society of Hematology (ASH) annual meeting in December 2024, showcasing the therapy’s safety and efficacy in combination with standard treatments.

Kura Oncology will also present new data from its KOMET-007 combination trial of ziftomenib at the ASH Annual Meeting. In the Phase Ia study, ziftomenib combined with standard therapies showed promising complete response rates and measurable residual disease negativity in high-risk AML patients. Additionally, a Phase Ib expansion study is actively enrolling across all cohorts, including combinations with venetoclax and azacitidine or cytarabine-based regimens.

XTALKS WEBINAR: Accelerate Precision Medicine Uptake With Impactful Scientific Engagement

Live and On-Demand: Thursday, December 12, 2024, at 1pm EST (10am PST)

Register for this free webinar to learn how precision medicine programs can be optimized through strategic lab partnerships, actionable data and multidisciplinary collaboration.

Meanwhile, at ASH, other leaders in hematology are contributing to the ongoing advancements in AML treatment.

Genentech plans to present more than 40 abstracts, including investigational data for AML and insights into combination therapies. Johnson & Johnson will highlight over 90 abstracts, with key updates on its Phase I menin inhibitor bleximenib, targeting NPM1 and KMT2A alterations in AML.

These concurrent efforts underscore the dynamic and competitive landscape in AML research, emphasizing the importance of ziftomenib’s development.

Through their partnership, Kura will spearhead efforts in the US, managing development, regulatory strategies and sales, with both companies sharing profits equally. Outside the US, Kyowa Kirin will lead commercialization efforts, leveraging its extensive expertise and infrastructure.

The collaboration also opens doors to potential applications in solid tumors, with Kyowa Kirin holding an option to co-develop ziftomenib in gastrointestinal stromal tumors and other indications. Preclinical data already suggest significant antitumor activity when combined with imatinib in advanced gastrointestinal stromal tumors, further validating its versatility.

Kura stands to receive up to $1.2 billion in milestone payments, including $330 million upfront and $420 million in near-term payments.

Kura’s CEO, Troy Wilson, noted that this financial backing, combined with the collaboration’s shared resources, will help accelerate ziftomenib’s journey from clinical trials to frontline AML treatment. Kura’s financial position remains strong, with a reported $455.3 million in cash and investments, providing operational runway into 2027.

Wilson further emphasized that this collaboration not only brings ziftomenib to the frontline setting but also represents a significant step toward fulfilling Kura’s commitment to precision oncology.