Biotherapeutics cross-reactivity

Toxicity that is due to off-target binding to either cell surface or secreted proteins is a leading cause of failure in drug development. Retrogenix’s Cell Microarray screening can provide an understanding of the off-target binding potential of novel biologic drug leads during discovery and early development. Building a picture of the ‘toxic liability’ of a candidate drug helps reduce risk through more informed safety assessment and can save considerable time and resources by allowing bad drugs to fail earlier. Retrogenix’s off target screening data has been used in regulatory submissions for clinical studies where high confidence in the specificity of a novel biotherapeutic is required.

Retrogenix off target profiling:

• Is the only platform for assessing for off-targets against both plasma membrane and secreted proteins that are expressed in human cells
• Provides supporting information for IND regulatory submissions, including submissions to the US FDA, EMA and China FDA
• Is highly specific with very low numbers of false positives/negatives
• Is used in addition to, or in place of, tissue cross reactivity (TCR) and immunohistochemistry studies
• Can predict/explain reduced bioavailability due to off-target binding
• Can inform pre-clinical tox model selection, reducing animal testing
• Helps prioritise drug leads or avoid off-target activities in next-generation of molecules