There is a strong need for assays that can provide adequate information on acute immunotoxicity and immune efficacy of monoclonal antibodies (mAbs) and other immune modulating drugs prior to first-in-human drug trials. Cellular assays and animal models fall short here. Cellular assays are devoid of immunoglobulins and/or complement split products, limiting the information gained from these experiments. mAbs interact with their target but also with Fc receptors on cells, and animal models are incapable of high-lighting both targets at the same time. Species differences also limit the information that can be drawn from such experiments.

Immuneed AB provides an ex vivo, first-in-class, human whole-blood assay for measuring drug-related acute immune toxicity, biodistribution and efficacy. The assay is offered as a specialized service.

The whole-blood loop assay

We offer a “first-in-human” assay that complements genetic and organ toxicity studies and provides improved drug know-how at an early stage. Advanced characterization services are paired with immunological know-how and expertise enabling us to link pre clinical data to clinical reality.

A preclinical program that includes the whole blood loop assay will help to:

  • select the right drug candidate
  • improve understanding of first-in-human reacions
  • increase understanding of how to design the initial clinical trial
  • reduce development costs and decrease/complement animal studies

The whole blood model uniquely contains all components: human immune cells, cascade systems (intact complement) and expression of correct Fc receptor that allow for proper investigation of potential immunological effects, drug immune cell distribution and adverse events of mAbs and other immune targeting therapies ex-vivo. The service can provide information on:

  • Immediate cytokine release
  • Complement activation
  • Cellular drug biodistribution
  • Immune recall responses (T cell memory)
  • Cell activation patterns

Our cytokine release assay (CRA) uniquely presents:

  • Low donor variability
  • Low background
  • Fast cytokine release read-out (4 hour assay)
  • Intact complement system

See table 1 for a comparison of our CRA assay with published data from other CRA assays.
Our assay is also highly suitable for investigating drug biodistribution, efficacy and mode of action (MoA)(Figure 1).

Table 1. Characteristics of our whole-blood loop assay compared to available published assays.

Figure 1. The whole-blood loop system can be used in various configurations to provide more clinically relevant data at an earlier stage.