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NI-One (NI-One SA) was a Swiss clinical-stage biotechnology company focused on the development of targeted therapies for inflammatory and autoimmune diseases. The company was established as an asset-centric entity to advance NI-0101, a first-in-class monoclonal antibody designed to block Toll-like receptor 4 (TLR4) signaling. In 2014, NI-One entered into a major strategic partnership with Servier to develop and commercialize NI-0101 globally. However, following a Phase 2 clinical trial in rheumatoid arthritis that failed to meet its primary endpoint in 2019, the company's development activities ceased. NI-One was a spin-off originating from the research and development programs of Novimmune.
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