Currently under codevelopment by Symphogen and Swedish Orphan Biovitrum,
rozrolimupab is the first in a new class of recombinant polyclonal
antibodies, known as symphobodies, produced using a proprietary technology from Symphogen.
Rozrolimupab is being investigated for the prevention of hemolytic disease of the fetus and newborn (HDFN) and for the treatment of
idiopathic thrombocytopenic purpura (
ITP).
Rozrolimupab comprises 25 genetically unique
IgG1 antibodies, all of which are specific for the rhesus D (RhD) erythrocyte
protein. In preclinical studies,
rozrolimupab demonstrated binding to erythrocytes that was comparable with that of two plasma-derived
anti-D Ig preparations. In a phase I clinical trial in healthy male volunteers, treatment with
rozrolimupab was not associated with serious adverse events. In a phase II clinical trial of
rozrolimupab in healthy, male, RhD-negative volunteers,
rozrolimupab dose-dependently cleared RhD-positive erythrocytes from the circulation. Phase II clinical trials in
ITP and HDFN are currently ongoing. Phase III clinical trials are necessary to establish the efficacy and safety profile of
rozrolimupab compared with standard plasma-derived
anti-D Ig preparations.