Non-GLP Exploratory Toxicology Studies in NHPs

Evaluate the physiological effects and safety of your immunotherapies with our comprehensive non-GLP NHP platform. Our models provide you with quick, cost-effective, and robust data to guide future GLP work and clinical trials.

NHPs are the only clinically-relevant model for assessing immune-related toxicity, allowing preclinical evaluation of potentially fatal clinical toxicities e.g. cytokine storm. NHPs have a high homology to humans, fully intact immune system, and cross-reactivity to antibodies which are not recapitulated in rodents or other larger animal models.

Advantages of our Non-GLP NHP Platform

• Save time and simplify logistics with I/O NHP toxicology and murine studies run at the same facility. Seamlessly move from mouse I/O work to NHP toxicology
  
  
• Reduce development time and improve cost effectiveness with onsite pathology/histopathology services, including IHC, ICC, and IF
  
  
• Rapid study initiation for fast turnaround of robust results - studies can be started within 4 weeks (dependent on test article availability), with study duration optimized to fit client and project needs
  
  
• Cost-effective pathway to guide your GLP studies – our exploratory non-GLP toxicology screen typically runs at a fraction of the cost of a GLP study

Comprehensive Non-GLP Analysis

Assess the immuno-safety of a range of I/O agents including mAbs, CAR-T cell therapies, ADCs, vaccines, small molecules, cytokines, and oncolytic viruses using:

• Healthy immunocompetent cynomolgus macaques
• A range of common administration routes
  • Intravenous injection or infusion
  • Intramuscular injection
  • Subcutaneous injection
  • Oral routes – via diet or gavage
• Perform FACS and immunoprofiling of common immune cell markers including cytokines, CD markers, immune checkpoint targets with fast turnaround on additional marker validation
• Analyze serum markers using industry gold standards: Beckman Coulter AU480 clinical chemistry analyzer, Luminex, MesoScale Discovery single and multi-plex systems
• Perform clinical observations to identify potential adverse effects related to cytokine storm/CRS
  • Changes in heart rate and/or body temperature
  • Facial redness or swelling
  • Vomiting, diarrhea, tremor, lethargy, low blood pressure, difficulty breathing

Figure 1: Representative NHP FACS profiling data

Figure 2: Representative cytokine and chemokine PLEX data

Table 1: Target panel for NHP profiling