AB2 Bio & Nippon Shinyaku Partner on U.S. License for Tadekinig Alfa
AB2 Bio and Nippon Shinyaku Sign U.S. Licensing Agreement for Tadekinig Alfa to Treat Ultra-Rare Autoimmune Disease
AB2 Bio Ltd., a Vaud-based biotech company specializing in therapies for severe hyperinflammatory diseases, has entered into a strategic agreement with Nippon Shinyaku, a leading Japanese pharmaceutical company, for the commercialization of its breakthrough treatment Tadekinig alfa in the U.S.
Under this option and licensing agreement, Nippon Shinyaku secures the right to exclusively market Tadekinig alfa for Primary Monogenic IL-18 driven Hyperinflammatory Syndrome, a rare and life-threatening pediatric disorder caused by mutations in NLRC4 and XIAP genes. If untreated, this condition can rapidly lead to multiple-organ failure and death.
Key Financial Terms
As part of the deal, AB2 Bio will receive:
- Up to $36 million in early payments, including an initial $6 million upon signing.
- Up to $150 million in development milestone payments.
- Up to $500 million in commercial milestone and royalty payments.
Nippon Shinyaku’s rights extend across the U.S., including Guam, Puerto Rico, and the U.S. Virgin Islands. However, AB2 Bio retains all commercialization rights for Tadekinig alfa in other indications in the U.S. and all markets outside the U.S.
A Strategic Partnership to Advance Treatment
This collaboration is expected to accelerate access to Tadekinig alfa for children suffering from hyperinflammatory syndrome, a disease with no currently approved treatments.
Dr. Djordje Filipovic, CEO of AB2 Bio, emphasized the importance of this agreement: “This partnership will help bring Tadekinig alfa to patients in urgent need of an effective treatment. Nippon Shinyaku’s expertise in rare diseases will be invaluable in maximizing the impact of this promising therapy.”
Dr. Toru Nakai, President & Representative Director of Nippon Shinyaku, also highlighted the significance of the treatment :”Monogenic IL-18 driven hyperinflammation is a devastating condition with no FDA-approved options. We are committed to working with AB2 Bio to deliver this groundbreaking therapy to patients in the U.S.
Tadekinig Alfa: A Novel Approach to Hyperinflammation
Tadekinig alfa is a recombinant human interleukin-18 binding protein (IL-18 BP) that neutralizes IL-18, a key inflammatory cytokine. In healthy individuals, IL-18 levels are naturally regulated. However, in patients with NLRC4 or XIAP mutations, IL-18 production goes unchecked, causing severe hyperinflammation and organ damage.By restoring IL-18 balance, Tadekinig alfa offers a targeted and potentially life-saving treatment.
Regulatory Progress and Future Prospects
AB2 Bio is actively preparing a Biologics License Application (BLA) submission to seek FDA marketing authorization in the U.S. Tadekinig alfa has already achieved several regulatory milestones, including:
Beyond Primary Monogenic IL-18 driven Hyperinflammatory Syndrome, Tadekinig alfa has shown clinical proof-of-concept in three additional life-threatening orphan diseases, reinforcing its potential as a groundbreaking therapy for various IL-18-mediated conditions.
A Step Forward for Patients
For children and families affected by hyperinflammatory syndrome, this agreement offers hope for an effective treatment. As AB2 Bio and Nippon Shinyaku advance their collaboration, Tadekinig alfa could soon become the first approved therapy for this ultra-rare disease, paving the way for new treatments in autoimmunity and inflammation.
➡️ Source: PR