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AB2 Bio secures USD 650 million partnership with Nippon Shinyaku for rare disease therapy

Life sciences

27 January 2025

EPFL Innovation Park biotech company AB2 Bio has signed an option and licensing agreement with Japan-based Nippon Shinyaku to advance Tadekinig alfa, a novel treatment for Primary Monogenic IL-18 driven Hyperinflammatory Syndrome. The deal includes up to USD 36 million in early payments and milestone-based funding of up to USD 650 million. Tadekinig alfa, developed by AB2 Bio, offers a novel approach to treating IL-18 driven hyperinflammatory syndromes, providing hope for patients with no current standard of care. | © AB2 Bio

EPFL Innovation Park biotech company AB2 Bio has signed an option and licensing agreement with Japan-based Nippon Shinyaku to advance Tadekinig alfa, a novel treatment for Primary Monogenic IL-18 driven Hyperinflammatory Syndrome. The deal includes up to USD 36 million in early payments and milestone-based funding of up to USD 650 million.

Based at the EPFL Innovation Park in Lausanne, AB2 Bio specializes in developing therapies for hyperinflammatory syndromes driven by IL-18, an inflammatory cytokine. Tadekinig alfa, the company’s leading therapeutic candidate, addresses the unmet medical needs of patients with Primary Monogenic IL-18 driven Hyperinflammatory Syndrome caused by NLRC4 mutation and XIAP deficiency.

This ultra-rare pediatric condition leads to severe, life-threatening inflammation that can result in multi-organ failure if left untreated. Tadekinig alfa, a recombinant human IL-18 Binding Protein, restores the balance of IL-18 levels, reducing hyperinflammation and preventing further damage.

Under the agreement, Nippon Shinyaku has secured an option to exclusively commercialize Tadekinig alfa for this lead indication in the U.S., including territories such as Guam, Puerto Rico, and the U.S. Virgin Islands. AB2 Bio retains rights for all other indications in the U.S. and worldwide.

A promising future for Tadekinig Alfa

The deal includes an initial payment of USD 6 million and additional development milestone payments of up to USD 150 million. Future commercial milestones and royalties could bring the total value of the agreement to USD 650 million.

“This partnership will accelerate bringing Tadekinig alfa to young patients suffering from this rare and devastating disease,” said Dr. Djordje Filipovic, CEO of AB2 Bio in the company’s press release. “Nippon Shinyaku’s expertise in commercializing rare disease therapies will be invaluable.”

Tadekinig alfa has already demonstrated clinical proof-of-concept in three orphan diseases, received Orphan Drug Designation in the U.S. and Europe, and holds U.S. Breakthrough Therapy and Pediatric Rare Disease Designations. These achievements position the treatment as a potential game-changer for hyperinflammatory diseases.