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NovImmune Successfully Completes NI-0801 Phase I Clinical Study

NovImmune, an immunology-focused biotech company dedicated to the development of therapeutic monoclonal antibodies, announced the successful completion of the first phase I clinical study with its fully human monoclonal antibody NI-0801 targeting the chemokine IP-10 (CXCL10) in healthy volunteers. The randomized, doubleblinded, placebo controlled, single centre, phase I study of escalating single intravenous doses of NI-0801 in healthy volunteers (study NI-0801-01) demonstrated that NI-0801 is well tolerated at doses up to and including 20mg/kg. Chemokines are a group of low molecular weight proteins that induce the chemotaxis of different leukocytes to sites of injury or infection. IP-10 is constitutively expressed at low levels in thymic, splenic and lymph node stroma tissues, but its expression can be induced on a variety of cell types including endothelial cells, keratinocytes, fibroblasts, monocytes and neutrophils. IP-10 not only mediates leukocyte recruitment, but also drives T-cell proliferation upon antigenic stimulation. Cell migration in response to chemoattractants requires the retention of IP-10, which is also true for all other chemokines, in the vicinity of the site of inflammation to make sure cells are recruited where they are needed. IP-10 expression at sites of inflammation, leads to local accumulation of specialized cells responsible for the inflammation process in a number of different autoimmune conditions including psoriasis, multiple sclerosis, ulcerative colitis, rheumatoid arthritis, atherosclerosis, liver fibrosis and sarcoidosis. Dr Penelope Ward, Chief Medical Officer commented that "since increased IP-10 (CXCL10) levels correlate with disease severity, an ability to neutralize its effects with a target specific monoclonal antibody offers a promising strategy for the treatment of diseases such as liver fibrosis and lupus, for which therapeutic options are currently limited." NI-0801 is well aligned within NovImmune"s overall expertise and strategy in the field of chemokines to develop potential future therapeutics. Along these lines NovImmune is very happy to have become a member of the European F6 consortium "Innovative Chemokine-based Therapeutic Strategies for Autoimmunity and Chronic Inflammation" (INNOCHEM). Dr Marie Kosco-Vilbois, CSO at NovImmune, commented that "it is a great pleasure and opportunity for NovImmune to be part of a European group of Excellence in the field of future therapeutic applications of the "chemiome", where eminent academic and industrial partners cooperate to translate chemokine biology into effective therapeutics." NovImmune SA


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