Toxicity due to off-target binding to either cell surface or secreted proteins is a serious cause for concern in drug development. Furthermore, demonstrating on-target specificity is a necessary hurdle in the race for regulatory approval for a novel biotherapeutic.
Retrogenix’s Cell Microarray screening provides an understanding of the off-target binding potential of a biologic candidate during discovery and early development. Building a picture of a biotherapeutic’s ‘toxic liability’ 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 extensively in regulatory submissions for clinical studies and marketing approval where high confidence in the specificity of a novel biotherapeutic is required.
Where Retrogenix results have been used in regulatory submissions:
- Data were accepted globally, with IND/BLA submissions to: US FDA, EMA (Europe), PMDA (Japan) & NMPA (China)
- Over a third of submissions that included Retrogenix results relied solely on these data for specificity assessment, with no tissue cross-reactivity (TCR) studies (38%)
- 90% of submissions using Retrogenix data have been approved to date.
More details on the use of Retrogenix’s IND-enabling specificity data can be found in our regulatory submissions survey results.
Retrogenix off target profiling:
- The only platform for assessing for off-targets against both plasma membrane and secreted proteins that are expressed in human cells
- Highly specific with very low numbers of false positives/negatives
- 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