Although IVIG has been a mainstay in autoimmune disease therapy for decades, there is still high variability in both safety and potency among different batches because the antibodies are sourced from pooled human blood. arGEN-X N.V. has developed a mutant constant region fragment of IgG1 that binds its receptor with higher affinity than IgG and has now shown that it can clear unwanted serum antibodies in nonhuman primates about 30 times more efficiently than standard IVIG.
arGEN-X's compound-ARGX-113-joins a wave of preclinical programs using recombinant approaches in a field that has seen little innovation until recently.
Since the demonstration of the broad therapeutic potential of IVIG (intravenous immunoglobulin) a few decades ago, there has been a dearth of therapies that improve upon it. Although there are at least six IVIG therapies on the market and at least three subcutaneous Ig (SCIG) compounds approved or on the market, there are no disclosed programs in the clinic for new forms of IVIG. By contrast, since 2011, at least 3 preclinical programs have been announced in addition to ARGX-113 (see "Ig therapies").
IVIG was originally used as replacement therapy in primary immune deficiencies