Abzena, an end-to-end integrated CDMO for complex biologics and bioconjugates, has launched its enhanced bioassay platform, EpiScreen 2.0, a suite of assays that predict and evaluate potential risks of preclinical immunogenicity in protein, antibody, and gene therapy therapeutics.
 
The next-generation tool provides a better immunogenic assessment that is highly sensitive, multi-parametric, and data-rich, which ultimately improves candidate selection and de-risks early-phase development.
 
The newly enhanced EpiScreen 2.0 builds upon the original platform launched over 20 years ago by delivering a more advanced set of immune response measurements with the required sensitivity, plus detailed information on specificity and mechanism-of-action (MoA) to better inform the nature of immunogenicity risk and how to mitigate this through protein engineering and formulation.
 
Using flow cytometry, EpiScreen 2.0’s Time Course Assay delivers levels of sensitivity comparable to traditional assays using [3H]-thymidine as a readout for proliferation and allows characterization of the responding immune cells by multiplexing the readout with cell activation markers. Beyond the standard assessment of CD4+ T cells, the platform can evaluate the responses of other immune cells, including CD8+ T-cells, giving insight into the MoA, which can be useful for gene therapy, where evaluation of the endogenous antigen processing pathway is more relevant. 
 
These data-rich assays can support an array of drug types including biologics, bioconjugates, and gene therapies, and can be delivered as a platform method or customized to each program to provide the necessary information needed to select the best candidate for clinical evaluation.
 
“Understanding a lead drug candidate’s immunogenicity risk profile and how we can mitigate it is a key step in advancing new drugs from discovery to clinical trials. We developed EpiScreen 2.0 because we understand that there are many factors that contribute to the immunogenicity risk of a drug, especially with the next-generation therapeutics being developed like Antibody-drug conjugates (ADCs),” said Dr. Campbell Bunce, CSO of Abzena. “Our EpiScreen 2.0 platform allows drug developers to be better informed and more confident in progressing to later stage development with a better chance of success in patients.”