Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.
Using imlifidase is a novel approach to eliminate pathogenic IgG. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their reactivity within hours after administration.
Hansa is leveraging its enzyme technology platform to develop immunomodulating treatments for rare IgG-mediated autoimmune conditions, transplant rejection and cancer.
The Research and Development program is advancing the unique enzyme technology to develop the next generation IgG-cleaving enzymes with lower immunogenicity, for repeat dosing. Imlifidase has a strong patent portfolio offering protection beyond 2035.
Potential for Imlifidase
SVP, Chief Scientific Officer
Hansa is seeking regulatory approval for imlifidase in the EU based on data from one Phase 1 study in 29 healthy individuals and four Phase 2 studies in 46 sensitized kidney transplant patients.
A Marketing Authorization Application is under evaluation by the European Medicines Agency since February 28, 2019. An opinion from the Committee for Medicinal Products for Human Use is expected within 210 working days of this date (plus clock-stops). Hansa is in dialog with the U.S. Food and Drug Administration regarding a path for regulatory approval in the U.S.