Toxicologic pathologists play a critical role in helping to determine the immunosafety of biopharmaceutical therapies. Although evaluating the immune system has been an important part of nonclinical drug development, there is an increase in complexity to immunosafety evaluation due to biopharmaceutical therapies or immunotherapies  now being developed with the expressed purpose to modify the immune system.

This adds layers of complexity for toxicologic pathologists, who must now interpret these modifications alongside immunotoxicologic effects when evaluating clinical relevance and potentially adverse immune system responses. As a result, toxicologic pathologists conducting nonclinical toxicology studies on immune-modulating therapeutics must consider many components when carrying out their evaluations.

In the 2023 opinion article titled “Toxicologic Pathology Forum: Considerations Regarding Determination of Adversity for Immunopathology Findings in Nonclinical Toxicology Studies with Immune-Modulating Therapeutics,” StageBio Senior Pathologist Dr. Tracey Papenfuss joins her co-authors to provide an overview on the challenges these immune-modulating therapies present in the field of immune system evaluation.

Dr. Papenfuss and her co-authors explain how current practices in immune system pathology may be insufficient for today’s immunomodulatory landscape. To do so, they review:

• The increased expectations to examine and interpret the effects of therapeutics (both immunomodulatory and non-immunomodulatory) on complex immune system pathways
• Standard immunotoxicologic and immunopathologic endpoints
• The need for incorporating immunosafety data into nonclinical evaluations

After this review, she and her co-authors go on to propose what they consider to be a practical framework for adversity decisions for immunopathology findings.

Access the opinion article from Toxicologic Pathology to learn more

Access the opinion article from Toxicologic Pathology for a brief overview of the challenges and considerations that immune-modulating therapies pose for toxicologic pathologists and considerations that may prove helpful when determining immune system adversity.