Safety Assessment

Cytokine Storms a-brewing… (Part 2) Considerations for CRAs? This is Part 2 of our series, “Cytokine Storms a-brewing…”. Miss Part 1? Catch up here. When are cytokine release assays (CRA) required? In the case of TGN1412, the biologic was an antibody. However, any product- whether a large biological molecule or small chemical- that has the potential to interact with the immune system should be tested. Furthermore, products targeting membrane-bound antigens could pose a higher risk for promoting cytokine release. Given that cancer immunotherapy is an increasingly popular field and many of its targets modulate the immune system, the products designed [...]

Cytokine Storms a-brewing… (Part 1) What is a cytokine storm?  A cytokine storm, or cytokine release syndrome (CRS), is a clinical event resulting from the infusion of antibody therapies in patients. The patients experience a massive release of pro-inflammatory cytokines, which leads to debilitating symptoms, severe multi-organ failure, and the need for advanced medical care1. Needless to say, this is an unwanted side-effect of the biologic. TGN1412 One of the most well documented cases of a biologic that caused a cytokine storm is TGN1412, an anti-CD28 “superagonist” antibody that was proposed to treat certain autoimmune diseases and hematologic cancers2.  While [...]