Tadekinig alfa is designed to bind and block IL-18. Credit: TheCorgi/Shutterstock.

AB2 Bio has made an option and licencing agreement with Nippon Shinyaku, granting the latter the option to obtain exclusive rights to commercialise Tadekinig alfa in the US.

This therapy treats a rare paediatric condition, primary monogenic interleukin-18 (IL-18)-driven hyperinflammatory syndrome, which can lead to rapid multiple organ failure and mortality if not treated.

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AB2 Bio will receive up to $36m in early payments, including a $6m payment upon signing.

The company could also receive up to $150m in development milestone payments and commercial milestone and royalty payments potentially amounting to $500m.

AB2 Bio is set to continue its preparations for a US biologics licence application (BLA) approval for the therapy for this indication.

Upon Nippon Shinyaku exercising its option rights and following AB2 Bio’s receipt of the BLA approval in the US, NS Pharma, Nippon Shinyaku’s wholly owned subsidiary, will undertake the marketing of the therapy.

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Nippon Shinyaku will have exclusive rights to commercialise Tadekinig alfa for its primary indication in individuals with NLRC4 mutation and X-linked inhibitor of apoptosis protein (XIAP) deficiency within the US.

AB2 Bio retains the rights to the therapy for all other indications within the country, including the US Virgin Islands, Guam and Puerto Rico, as well as for all indications in other parts of the world.

AB2 Bio CEO Djordje Filipovic stated: “This partnership will accelerate bringing Tadekinig alfa to young patients suffering from this rare and devastating disease and potentially provide a significant improvement in treatment.”

Tadekinig alfa is a recombinant human IL-18 binding protein.

In April 2024, MiNA Therapeutics entered a research partnership and licensing agreement with Nippon Shinyaku. The collaboration is focused on developing small activating RNA therapeutics for rare neurodegenerative conditions.