EpiVax, Inc. ('EpiVax'), a biotechnology company with expertise in T cell epitope prediction, immune modulation, and rapid vaccine design, announced on Monday that it has received a two-year USD2m grant from the FDA's Office of Center for Drug Evaluation and Research (CDER) to validate a method for immunogenicity risk evaluation of host cell proteins (HCP) for improving biosimilar product development and assessing product interchangeability.

The research is to start in September 2022 and complete in August 2024.

This new grant is to allow the company to showcase the potential of in silico tools for screening and triaging HCPs to induce an unwanted immune response in patients receiving the biosimilar. It is based on research being carried out on immunogenicity risk evaluation with the FDA's Office of Generic Drugs.