Drug intelligence / Profile preview

GBS hyperimmune IVIG

Development stage
Preclinical
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

GBS hyperimmune IVIG is a specialized intravenously administered immune globulin (IVIG) product developed by immunizing plasma donors to achieve high levels of Group B Streptococcus (GBS) type-specific antibodies. This hyperimmune formulation exhibits significantly greater GBS type-specific opsonic activity compared to standard IVIG, demonstrating a >90% activity at a 1:1280 dilution versus 1:10 for standard IVIG. Preclinical studies in suckling rats showed 100% survival after GBS type-specific infection when treated with GBS hyperimmune IVIG, compared to less than or equal to 20% with standard IVIG. Clinical evaluation in neonates with suspected sepsis indicated that GBS hyperimmune IVIG, particularly at a 500 mg/kg dose, produced a sustained fourfold increase in serum GBS type-specific IgG for over six weeks, along with a correlated rise in opsonic activity, without observed adverse effects. The product aims to provide passive immunity against GBS infections, particularly in vulnerable populations like neonates.

Other names
hyperimmune IVIG
02

Targets

GBS CPS (Group B Streptococcus capsular polysaccharide)

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