Nonclinical Safety Assessment for A Multispecific Antibody
Multispecific antibodies (MsAbs) show great promise for tumor immunotherapy due to their increased binding specificity and reduced off-target toxicity, which are critical aspects of multispecific antibody safety. Comprehensive safety evaluations are essential to fully evaluate the safety of the therapeutic antibodies.
This study assesses the safety of an MsAb candidate designed to bind to cell cycle-related targets and a tumor-associated antigen (TAA), aiming to enhance T-cell activation and improve tumor targeting.
For the comprehensive safety evaluation of the multispecific antibodies, naïve cynomolgus monkeys were dosed for four weeks followed by a four-week recovery period. The following assessments were performed:
- Toxicokinetics
- Antidrug antibody (ADA) analysis
- Immunophenotyping
- Cytokine profiling
- Serum circulating immune complexes (CIC)
- Clinical pathology, safety pharmacology, and histopathological assessments
Download our Multispecific Antibody Safety poster to read the full case study.