EndocrinologyNovImmune 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