NovImmune successfully completes NI-0801 Phase I clinical study

NovImmune 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

Geneva - Switzerland | July 13, 2009 | NovImmune, an immunology-focused biotech company dedicated to the development of therapeutic monoclonal antibodies, announced today 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, double-blinded, 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

NovImmune SA ("NovImmune") is a drug discovery and development company with a focus on therapeutic mAbs for inflammatory diseases and immune-related disorders.

NovImmune has generated, to date, seven proprietary mAbs. The pipeline is a balance of preclinical and clinical compounds, with a mix of both clinically validated as well as novel targets. Each of these portfolio products has the potential to become a medicine for multiple medical conditions due to the overlapping mechanism of action under laying these types of diseases.

Two compounds are in clinical development, with the most advanced in clinical phase II. The lead product, NI-0401/anti-CD3, is currently being tested in Crohn's disease, type 1 diabetes and transplantation. The company was established in 1998 and has currently 75 employees based in Plan-les-Ouates/Geneva, Switzerland.

SOURCE: NovImmune SA

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