Preclinical Safety Testing / Immunotoxicology

Preclinical immune safety assessments entail the evaluation of drug effects on the immune system in relation to the potential impact on human health. Five areas of concern include immunotoxicity (immunosuppression), immunostimulation, hypersensitivity, autoimmunity and immunogenicity. Although there is little difficulty identifying potent immunosuppressive drugs in animal studies, it can be a challenge to interpret the potential clinical consequences of other immunomodulatory events such as immunostimulation or hypersensitivity responses. The acceptable degree of immunomodulation will depend on the balance between desired pharmacology, margin of safety, and the disease indication.

Many of today’s biotechnology drug candidates are immunomodulatory either by design or as an unintended side effect. This attribute is in addition to the inherent immunogenicity potential of each biopharmaceutical. A properly designed preclinical immune safety evaluation should include the characterization of both the immunopharmacology and immunotoxicology effects of
the drug candidate, as well as the determination of immunogenicity. This combined approach may also reveal or verify a relevant pharmacological biomarker of drug activity.

We offer sponsors the capability of custom designing preclinical immune safety endpoints into standard toxicology studies that will meet current regulatory expectations for preclinical immunotoxicity and immunogenicity screening. Endpoints include anti-drug immunogenicity, immunophenotyping, T-cell dependent antibody responses (TDAR), and other functional cellular immune assays as needed. This enhanced approach informs the interpretation of drug-induced immunomodulation in the context of the overall toxicology package and aids in the identification of potential immune safety liabilities.

B2S Life Sciences