PR97763

PROVIDENCE, R.I., Sept. 12, 2022 /PRNewswire=KYODO JBN/ --

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.

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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 rnolan@epivax.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

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 & Marketing

EpiVax

kporter@epivax.com

SOURCE  EpiVax Inc.