Kura Oncology & Kyowa Kirin Ink Global Strategic Collaboration to Commercialize Ziftomenib

Kura Oncology & Kyowa Kirin Ink Global Strategic Collaboration to Commercialize Ziftomenib

By, Admin 23 November 2024

Kura Oncology & Kyowa Kirin ink global strategic collaboration to develop and commercialize ziftomenib in acute leukaemias

Overview

Kura Oncology, Inc., a clinical-stage biopharmaceutical company, and Kyowa Kirin Co., Ltd., a global specialty pharmaceutical company, announced they have entered into a global strategic collaboration to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor, being investigated for the treatment of patients with acute myeloid leukaemia (AML) and other hematologic malignancies.

Terms of the Agreement

  • Under 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, totalling up to $1.161 billion in payments for milestones and the opt-in for solid tumour indications.

Kura Work Post Agreement

  • In the US, 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 US territory commercialization plan and will share equally in any potential profits and losses.

Kyowa Kirin Post Agreement

  • Outside the US, 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 a Japan based global specialty pharmaceutical company, Kyowa Kirin aims to create treatments with life-changing value that bring smiles to people living with disease. 
  • The company will leverage its haemato-oncology experience and capabilities, and its deep commitment to partnerships, to successfully bring ziftomenib to market globally.

Words from the CSO: Kyowa Kirin

  • We believe that ziftomenib is a very promising investigational treatment for genetically defined AML patients,” said Yasuo Fujii, MBA, chief strategy officer, managing executive officer of Kyowa Kirin. 
  • The addition of ziftomenib will complement Kyowa Kirin’s existing haemato-oncology portfolio and pipeline and expand our clinical development efforts into combination therapies designed to generate improved outcomes for cancer patients. We look forward to collaborating closely with the team at Kura and adding ziftomenib to our portfolio of oncology candidates as part of our commitment to bringing new, advanced treatment options to patients and the clinical community around the world.

About Ziftomenib

  • Ziftomenib is the first and only investigational therapy to receive breakthrough designation from the US Food and Drug Administration (FDA) for the treatment of R/R NPM1-mutant AML, a mutation that is associated with poor outcomes. 
  • Enrollment in a phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed and the companies anticipate submission of a New Drug Application (NDA) in 2025. 
  • Kura is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. 
  • Kura expects to initiate registrational phase 3 frontline studies in both the fit and unfit frontline AML patient populations in 2025.

Statement from the CEO: Kura Oncology

  • 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,” said Troy Wilson, Ph.D., J.D., president and chief executive officer of Kura Oncology. 
  • Kyowa Kirin is a wonderful partner for Kura, bringing the expertise and scale of a global pharmaceutical company. On behalf of our leadership team and board of directors, we are thrilled to be working with Kyowa Kirin to realize the potential of ziftomenib as a transformational therapy for AML patients.
  • Importantly,” Dr. Wilson continued, “we believe the upfront and anticipated milestone payments from this collaboration combined with our current cash position should provide sufficient funding to support the ziftomenib program to commercialization in the frontline setting, which we believe is a market opportunity of up to $3 billion annually in the US alone.

Both Companies Post Regulatory Approval

  • Following regulatory approval, Kura will book sales and take the lead role in US commercial strategy development and both parties will share in commercialization activities. 
  • Profits and losses from the commercialization activities will be shared equally in the US Outside the US, Kyowa Kirin will lead and perform commercialization activities, book sales and be responsible for the conduct and funding of commercialization of ziftomenib, and Kura is eligible to receive tiered double-digit royalties on net product sales.

Responsibility for Clinical Trial Conduction 

  • 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 ratios. 
  • The companies will share equally the funding of future trials in the US. 
  • The agreement includes plans to launch multiple phase 2 and phase 3 studies of ziftomenib in AML and other haematologic malignancies over the next several years. 
  • Development and commercialization activities under the collaboration will be managed through a shared governance structure.

Terms of the Agreement

  • Under the Agreement, Kyowa Kirin has an option to participate in the development and commercialization of ziftomenib in gastrointestinal stromal tumours (GIST) and other solid tumour 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 totalling $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.

Kura was advised in the transaction by BofA Securities and represented by Cooley LLP.

About the Menin Inhibitor: Ziftomenib

  • Ziftomenib is a selective and oral menin inhibitor currently in development for the treatment of genetically defined AML patients with high unmet need. 
  • In April 2024, ziftomenib received Breakthrough Therapy Designation (BTD) by the FDA for the treatment of R/R NPM1-mutant AML based on data from Kura’s ongoing KOMET-001 clinical trial.

About the Company: Kura Oncology

  • Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. 
  • The company’s pipeline consists of small molecule drug candidates that target cancer signalling pathways.

About the Company: Kyowa Kirin

  • Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. 
  • As a Japan-based global specialty pharmaceutical company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable haematological diseases/haematology and rare diseases.

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