There are many ways that a drug or biologic therapy can impact the immune system, many of which aren’t discovered in the early stages of drug development. For example, chemotherapies that impede the development of hematopoietic cells can leave cancer patients anemic and prone to infection.
So how can you identify the negative immune system effects of your new drug candidate before it’s too late? Immunotoxicity product testing before clinical trials.
3 Things to Look For in Early Immunotoxicity Research
Many pharmaceutical developers skip this early product research. However, proper testing at an early stage can ensure a more productive and successful clinical trial by identifying potential reactions or immunotoxic behavior.
Some drugs can have unpredicted effects that are unique to immune cells. Comprehensive immunotoxicity testing before in vivo testing can help you identify negative effects or unpredicted behaviors so they can be corrected and prevented. Here are three effects we typically look for in early stage drug testing:
1. Cytokine Storm
This is the nightmare scenario of immunotoxicity. If your drug candidate exhibits cytokine storm in a pre-clinical or Phase I trial, the drug—and potentially your company—will fail.
When drug development company TeGenero introduced their immunomodulatory drug (monoclonal antibody to CD28) to healthy human volunteers in 2006, an unpredicted interaction caused severe, nearly deadly, inflammatory responses in all human trial participants.
The immunostimulatory effects of the antibody triggered cytokine release from lymphocytes, causing the study participants to experience pulmonary edema, tremendous swelling from the release of fluid, and organ failure—reactions not expressed in prior animal testing. The “TeGenero Incident” led to the immediate withdrawal of the drug and eventual bankruptcy of the company.
You don’t want to be the next TeGenero. Test your drug with in vitro assays to detect harmful immunotoxicity before you give your drug to humans.
2. Altered Normal Immune Response
Depending on your drug’s goals, you may or may not want to modulate the immune response to your drug.
It’s important to test the human immune system’s ability to eliminate pathogens, toxins and allergens and maintain normal cell function when exposed to your drug. Adding your drug to recall antigen responses can provide a measure of the drug’s ability to inhibit or enhance immune reactions, giving you a clearer idea of how your drug will perform in in vivo or clinical trials so you can make any necessary adjustments.
3. Cell Type-Specific Effects
When your drug aims to affect a relatively small cell population, it’s critical to experiment on the target cells before conducting further research. Experimenting on specific cell types will help to eliminate confounding variables.
We specialize in providing pure, viable cell samples for reliable test results. Our researchers have conducted extensive cell-specific drug testing using macrophages, dendritic cells and B cells for our customers whose drugs target those specific cell populations.
Your First Step in Discovery
Astarte specializes in early stage discovery and pre-clinical research. Contact us to get started on your research project.