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EpiVax and CUBRC Awarded FDA Contract Worth $2M for Development of Control Peptides for Immunogenicity Risk Assessment Assays

Oct 24, 2024over 1 year ago

Contract Type

contract

ProvidenceBiotechnology

Description

EpiVax, Inc. and CUBRC, Inc. have been awarded a two-year, $2 million contract from the FDA to develop standardized controls for T cell assays to assess immunogenicity risk of generic drugs, supporting ANDA applications as outlined in the relevant FDA guidance.

Company Information

Company

EpiVax

Location

Providence, Rhode Island, United States

About

EpiVax has developed advanced immunogenicity risk assessment tools (ISPRI and 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 rnolan@epivax.com.The 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 smoniz@epivax.com.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. About EpiVax: 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.Press Contact:Katie Porter, Associate Director, Business Development & MarketingEpiVax kporter@epivax.comSOURCE EpiVax Inc.

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