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