#EpiVax #Immunogenicity #Biological Therapies

EpiVax: Pioneering Immunogenicity Innovations in 2024

EpiVax, Inc., a prominent player in the preclinical risk assessment of immunogenicity for biological and peptide therapeutics, has celebrated a highly productive year in 2024 characterized by scientific innovation, diversification of services, and substantial growth. Over the past year, EpiVax has significantly expanded its range of immunogenicity risk assessment services through the introduction of numerous features in the ISPRI™ (Immunogenicity Screening and Protein Re-engineering Interface) Toolkit and various new evaluation offerings.

Key achievements this year include the launch of several fee-based analytical options such as ISPRI Downselect™, Quantify™, Analyze™, Evaluate™, Complete™, Optimize™, and Design™. These new features provide comprehensive evaluations of biological modalities across various phases of preclinical development. The tools facilitate single-candidate ranking, modality-specific benchmarking, sequence optimization, and in-depth risk analyses with improved accuracy.

Notably, a Class I analysis was incorporated into the ISPRI toolkit for certain gene therapy and CAR-T clients, enabling enhanced evaluation capabilities. Additionally, EpiVax advanced its PANDA® Screening Program to assist sponsors navigating the FDA’s ANDA (Abbreviated New Drug Application) pathway for generic peptides and related impurities. Significant enhancements included a more extensive array of adaptive in-vitro tests and the introduction of the Innate Immune Response Assay. EpiVax has established itself as a