EpiVax, Inc. (“EpiVax”) is pleased to announce the award of a two-year, $2 million grant from the FDA’s Office of Center for Drug Evaluation and Research (CDER) to validate a method for immunogenicity risk assessment of host cell proteins (HCP) for improving biosimilar product development and assessing product interchangeability (# U01FD007760). The research will commence in September 2022 and conclude in August 2024.
Biosimilars are biological products, produced using a novel process, that have been demonstrated to be biosimilar with an FDA-approved biological product. No clinically meaningful differences may be present in comparison to the reference product. The number of biosimilars reaching the market is expanding rapidly as biologic products come off patent. Nearly 40 biosimilars have been approved by the FDA ( https://c212.net/c/link/?t=0&l=en&o=3643760-1&h=2335433376&u=https%3A%2F%2Fwww.fda.gov%2Fdrugs%2Fbiosimilars%2Fbiosimilar-product-information&a=Nearly+40+biosimilars+have+been+approved+by+the+FDA ), lowering healthcare costs for patients.
This new grant will enable EpiVax to demonstrate the utility of in silico tools for screening and triaging HCPs for their potential to induce an unwanted immune response in patients receiving the biosimilar. Access to in silico tools that have been validated in pre-clinical studies should improve the safety of biologics and expedite the immunogenicity risk assessment process for biosimilars. This new grant funding builds on research being conducted on immunogenicity risk assessment with the FDA’s Office of Generic Drugs (Contracts 75F40120C00157 ( https://c212.net/c/link/?t=0&l=en&o=3643760-1&h=3067469374&u=https%3A%2F%2Fepivax.com%2Fnews%2Ffda_baa_whim_pressrelease&a=75F40120C00157 ), HHSF223018186C ( https://c212.net/c/link/?t=0&l=en&o=3643760-1&h=2962560944&u=https%3A%2F%2Fepivax.com%2Fnews%2Fbreaking-news-fda-awards-1-million-epivax-cubrc-assess-generic-peptide-drugs&a=HHSF223018186C )). These past and present projects support the development of in silico tools and methods to assess risk of product and process-related impurities.
EpiVax has developed advanced immunogenicity risk assessment tools (ISPRI ( https://c212.net/c/link/?t=0&l=en&o=3643760-1&h=1945428241&u=https%3A%2F%2Fepivax.com%2Fimmunogenicity-assessment%2Fispri-web-based-immunogenicity-screening&a=ISPRI ) and ISPRI-HCP ( https://c212.net/c/link/?t=0&l=en&o=3643760-1&h=2101407496&u=https%3A%2F%2Fepivax.com%2Fimmunogenicity-assessment%2Fchoppi_ispri_hcp&a=ISPRI-HCP )) that are used by top tier biologics developers around the globe. The secure, cloud based ISPRI platform can be accessed by contacting EpiVax at the following email email@example.com.
The PANDA program for generic peptide impurities ( https://c212.net/c/link/?t=0&l=en&o=3643760-1&h=2709913033&u=https%3A%2F%2Fepivax.com%2Fimmunogenicity-assessment%2Fpanda-screening&a=PANDA+program+for+generic+peptide+impurities ) is currently used by a wide range of generic peptide sponsors from the USA, Europe, India, and Korea. Information on PANDA is available by contacting firstname.lastname@example.org.
According to Dr. Amy Rosenberg, EpiVax’s Senior Director of Immunology and Protein Therapeutics “Host Cell Proteins have strong potential to enhance immunogenicity of biological therapeutics. Rapid and accurate methods for identifying of higher risk and lower risk HCP will permit drug developers to improve the safety profile of their biologic products.”
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $1,999,984.00 USD with 100 percent funded by FDA/HHS. The contents of this Press Release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
EpiVax is a biotechnology company with expertise in T cell epitope prediction, immune modulation, and rapid vaccine design. EpiVax’s immunogenicity screening toolkits for therapeutics and vaccines, ISPRI and iVAX, are employed in advancing the research of a global roster of companies.
For more information about EpiVax, visit www.epivax.com.
Katie Porter, Associate Director, Business Development & Marketing
SOURCE EpiVax Inc.