FDA Awards $1.1M Contract to CUBRC and EpiVax for Validation of New Immunoinformatic Tool for Prospective Immunogenicity Assessment of Peptide Drugs and Their Impurities

PROVIDENCE,Rhode Island,Oct. 22,2020 --EpiVax,Inc. ("EpiVax") and CUBRC,Inc. ("CUBRC") announced today that they have been awarded a two-year,$1.1 million contract from the Office of Generic Drugs (OGD) in the Center of Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) in response to a Broad Agency Announcement (BAA),FDA BAA-20-00123.

This program continues research performed during a previous two-year collaboration between EpiVax and CUBRC. Under the previous FDA contract,EpiVax demonstrated the value of in silico tools and in vitro validation methods for the evaluation of generic peptide drugs and their impurities. EpiVax analyzed the immunogenic risk of two generic peptide drugs,applying the concepts outlined in FDA draft guidance,ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin,published in 2017.

Since initiating the program,EpiVax has produced the What-if Machine (WhIM) – an advanced immunoinformatics tool that performs iterative modifications to synthetic peptide drugs entirely in silico,generating a comprehensive list of all potential impurities that may occur due to deletions,insertions,duplications or side chain modifications at any residue of the active pharmaceutical ingredient (API). EpiVax uses existing algorithms to rank the impurities produced by the WhIM for their immunogenic potential in global patient populations. This output will enable one to identify high-,moderate-,and low-risk impurities prospectively. The new contract will provide proof of concept for the WhIM,again using two case studies as validation. EpiVax will continue to work with Katie Edwards,PhD (CUBRC),Prime Technical Program Lead,to achieve the goals set out in the contract.

Annie De Groot,MD (CEO/CSO,EpiVax) stated,"The WhIM has significant potential to contribute to prospective identification of high-risk impurities,allowing for generic peptide drug products to be de-risked early in the development process."

About the Draft FDA Guidance on Generic Peptide ANDAs

The draft guidance issued by the Office of Generic Drugs highlighting the use of in silico analysis in accelerated new drug applications for generic peptide drugs can be found here (UCM578365).

About EpiVax

EpiVax is a biotechnology company leading in the fields of immunogenicity risk assessment of biologic products and computational vaccinology with expertise in T cell epitope prediction,immune modulation,and rapid vaccine design. Visit www.epivax.comfor more information.

About CUBRC

CUBRC is an independent not-for-profit scientific corporation that executes Research,Development,Testing and Systems Integration programs in Medical Sciences,Chemical and Biological Defense,Data Science and Information Fusion,Command and Control,and Hypersonics. Visit www.cubrc.orgfor more information.

FDA Funding Statement

The FDA sponsors the project referenced in this press release. The content of the information does not necessarily reflect the position or the policy of the federal government,and no official endorsement should be inferred. The entire project (~$1.1M) will be financed with federal money.

Press Contact:

Katie Porter,Business Development Manager,EpiVax

E: KPorter@epivax.com

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