Abzena, an end-to-end integrated CDMO for complex biologics and bioconjugates, launched its enhanced bioassay platform EpiScreen 2.0, a comprehensive suite of assays that predict and evaluate potential risks of preclinical immunogenicity in protein, antibody and gene therapy treatments.
The next generation tool provides a better immunogenic assessment that’s highly sensitive, multi-parametric and data-rich, which ultimately improves candidate selection and de-risks early phase development.
What does it do?
The newly enhanced EpiScreen 2.0 builds upon the original platform 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, as well as facilitating characterisation of the responding immune cells by multiplexing the readout with cell activation markers.
What does it measure?
Beyond the standard assessment of CD4+ T cells, the platform can evaluate the responses of CD8+ T-cells, giving insight into the MoA.
This can be useful for gene therapy, where the 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 customised to each program to provide the necessary information needed to select the best candidate for clinical evaluation.
Dr Campbell Bunce, CSO of Abzena said: “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).”
