AB2 Bio

About AB2 Bio

AB2 Bio Ltd. is a clinical-stage biotechnology firm established in 2010, operating from the Innovation Park of the École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland. The company concentrates on creating therapies for severe systemic hyperinflammatory diseases driven by the cytokine Interleukin-18 (IL-18). Since its founding, AB2 Bio has secured over CHF 70 million through four financing rounds from investors across Switzerland, the EU, and the US. A significant Series B financing round in 2016 raised CHF 21 million, which was allocated to advance clinical trials.

The company's core business revolves around the development and commercialization of its lead product, Tadekinig alfa. This product is a recombinant human IL-18 binding protein (IL-18BP) designed to neutralize the pro-inflammatory cytokine IL-18. In healthy individuals, naturally occurring IL-18BP keeps free IL-18 levels in check, but in certain inflammatory diseases, this balance is disrupted, leading to pathological inflammation. By administering exogenous IL-18BP, AB2 Bio aims to restore this balance and reduce inflammation. To support this therapeutic approach, the company has also developed a proprietary assay capable of measuring free IL-18 in body fluids, enabling the identification of patients most likely to respond to the treatment.

AB2 Bio is currently conducting a pivotal Phase III clinical trial for Tadekinig alfa in patients with primary monogenic IL-18 driven hyperinflammatory conditions, specifically NLRC4 mutation and XIAP deficiency. These are rare and potentially fatal pediatric diseases that can lead to multiple-organ failure if untreated. The drug has received Breakthrough Therapy Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA). The company's business model involves out-licensing and strategic partnerships for commercialization. A key milestone was the January 2025 option and licensing agreement with Nippon Shinyaku, a Japanese pharmaceutical company. This agreement grants Nippon Shinyaku an option for exclusive U.S. rights to commercialize Tadekinig alfa for its primary indication. The deal structure includes upfront and early payments of up to USD 36 million, with potential development and commercial milestones reaching up to USD 650 million, plus royalties. AB2 Bio retains commercialization rights for all other indications in the U.S. and for all indications in the rest of the world.