January 27, 2025 - AB2 Bio signs U.S. option and licensing agreement with Nippon Shinyaku for Tadekinig alfa for an ultra-rare autoimmune disease
• Agreement grants Nippon Shinyaku an option to acquire exclusive U.S. rights to commercialize AB2 Bio’s Tadekinig alfa to treat Primary Monogenic IL-18 driven Hyperinflammatory Syndrome in patients with NLRC4 mutation and XIAP deficiency
• AB2 Bio receives early payments of up to USD 36 million (including an initial payment of USD 6 million upon signature) and would be eligible for development milestone payments of up to USD 150 million and and commercial milestone and royalty payments of up to USD 500 million
News release: English
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March 7, 2023 - AB2 Bio completes Enrolment in Pivotal Phase 3 Trial of Tadekinig alfa to Treat Primary Monogenic IL-18 Driven HLH
• Topline pivotal Phase 3 results expected during second half of 2023
• Potential new treatment option in ultra-rare, life-threatening, primarily pediatric disease with no approved therapies
News release: English
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August 25, 2021 - AB2 Bio expands Phase 3 trial of Tadekinig alfa in monogenic HLH
• Recruitment to the pivotal Phase 3 has been opened up to adults in addition to children
• Currently recruiting in the U.S., Canada and Germany
News release: English
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December 16, 2020 - AB2 Bio appoints Dr. Djordje Filipovic as Chief Commercial Officer
• Will drive commercial strategy and execution of Tadekinig alfa, currently in Phase 3
• Joins AB2 Bio from Novartis and has extensive commercial and strategic experience
Press release: English
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October 29, 2020 - AB2 Bio and WuXi Biologics Announce Collaboration to Accelerate Commercial-Scale Manufacturing of Tadekinig alfa
• Tadekinig alfa is a novel IL-18 binding protein in pivotal Phase 3 testing for orphan disease IL-18 driven monogenic Hemophagocytic Lymphohistiocytosis (HLH)
• WuXi Biologics to undertake commercial scale manufacturing to support U.S. market launch
Press release: English
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March 3, 2020 - AB2 Bio appoints Michael Soldan CEO, an experienced industry executive to prepare market entry of lead product, Tadekinig alfa to treat HLH and other rare, orphan diseases.
Press release: English
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March 21, 2019 - AB2 Bio announces readiness for recruitment in pivotal Phase 3 trial of Tadekinig alfa, a novel human recombinant interleukin-18 binding protein, in children with genetic diagnosis of NLRC4-MAS mutation or XIAP deficiency, with amended design in the U.S. and Canada.
Press release: English
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April 3, 2017 - AB2 Bio Ltd’s Tadekinig alfa therapy receives Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of monogenic, Interleukin-18 (IL-18) associated autoinflammatory conditions with ongoing systemic inflammation. In addition, AB2 Bio Ltd receives Orphan Drug Designation from the FDA for the treatment of Haemophagocytic Lymphohistiocytosis (HLH).
• Breakthrough Therapy Designation (BTD) recognises the major potential therapeutic benefits of Tadekinig alfa (IL-18BP) in the treatment of severe and potentially fatal autoinflammatory conditions
• FDA BTD and ODD status supports the accelerated development of Tadekinig alfa
Press release: English / Français / Deutsch
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November 29, 2016 - AB2 Bio Ltd receives Orphan Drug Designation from the European Medicines Agency for the treatment of Haemophagocytic Lymphohistiocytosis (HLH)
• Important regulatory milestone recognizing the potential therapeutic benefits of IL-18BP in treating HLH, a broad family of severe autoinflammatory diseases with high unmet medical need
• EMA ODD status supports accelerated Phase III development of Tadekinig alfa (IL-18BP)
Press release: English / Français / Deutsch
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January 11, 2016 - AB2 Bio Ltd raises CHF 21 million (USD 21 million) in Series B financing round
• Over CHF 41 million raised since the foundation of the company
• Strong commitment from current and new investors
• Company funded through Phase II trial in Adult onset Still’s disease and a pivotal Phase III trial in a rare genetic disease
Press release: English / Français / Deutsch
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November 9, 2015 - AB2 Bio Ltd achieves a medical breakthrough in the treatment of systemic inflammation
• Drug candidate effective in treating a baby girl carrying a newly identified, potentially fatal, genetic mutation causing severe systemic inflammation
• Case report to be presented at the Annual Meeting of the American College of Rheumatology (ACR)
Press release: English / Français / Deutsch
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Investor & Media Relations:
Chris Maggos
Cohesion Bureau
Phone: +41 79 367 62 54