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NHP Immuno-Safety

De-risk clinical trials with early toxicity screening of I/O agents

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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

Marker
Immune Cell Population
CD45 Total leukocytes
CD3 Total T cells
CD4 CD4+ T helper cells
CD8 CD8+ Cytotoxic T cells
CD44/CD62L Naive, memory and effector T cells
CD69/CD44/OX40/CD25 etc Activation markers
CD4+CD25+FoxP3+ Regulatory T cells
CD11b+IA/IElow/- G-MDSC and M-MDSC
Ly6c/Ly6g Macrophages
CD11b+ F4/80 M1 and M2 Macrophages
IA/IE/CD11c/CD206 NK cells
CD3-CD335+ NKT cells
CD3-CD335+ B cells
CD19 Cytokines
TNF-a/IFN-r/IL-7/IL-3 etc Checkpoint inhibitors
Granzyme B etc Commonly requested markers
KI67/Brd U/PNCA et Proliferation
Live/Dead (fixable) Live/Dead
CD45 Total leukocytes
CD3 Total T cells

Table 1: Target panel for NHP profiling