It is widely accepted that the fraction of human Intravenous Immunoglobulin (IVIG) that is primarily responsible for its efficacy in the treatment of autoimmune disease patients is the Fc portion of IgG1 that clusters as higher molecular weight fractions in IVIG. Gliknik rationally designed GL-2045, a first-in-class recombinant biologic, to form ordered multimers of IgG1 Fc in order to mimic the active fraction of IVIG for treating autoimmune diseases.
We designed recombinant GL-2045 to mimic the structure and efficacy of the very small and variable portion of the pooled human blood product IVIG that has been shown to be the most active fraction in treating autoimmune disorders.
In 2013, Pfizer and Gliknik entered into an exclusive worldwide license agreement to allow Pfizer to develop and, if approved by applicable regulatory authorities, commercialize GL-2045.
In 2015, the U.S. Food and Drug Administration granted Orphan Drug designation to GL-2045 for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
There are numerous marketed brands of IVIG with some products approved for use in the autoimmune indications including CIDP, multifocal motor neuropathy (MMN), and idiopathic thrombocytopenic purpura (ITP). However, there is an unmet need for a medicine that has a safer and more convenient administration profile compared to that of IVIG. GL-2045 was designed to be an alternative therapy to IVIG in treating these and other autoimmune diseases. While IVIG is produced by pooling and purifying plasma from tens of thousands of human blood donors, GL-2045 is recombinant, so it does not carry the risk of blood-borne pathogen transmission and its increased potency may enable infusion of smaller volumes over shorter infusion periods, thereby potentially improving the treatment regimen and quality of life for these patients.
IVIG is also approved for treating immunodeficiency disorders, acting primarily through the Fab portion of IgG1. GL-2045 does not contain an Fab and was not designed to treat these patients. However, since GL-2045 is a recombinant entity, it can, in theory, be produced in limitless quantities. If successfully commercialized, GL-2045 might allow more of the IVIG products, currently used to treat both immunodeficiency disorders and autoimmune indications, to be available for individuals living with immunodeficiency disorders, thereby helping to address a chronic worldwide IVIG supply shortage.