EpiVax and CUBRC Awarded FDA Contract Worth $2M for Development of Control Peptides for Immunogenicity Risk Assessment Assays Supporting Regulatory Filings of Generic Peptide Drugs

EpiVax, Inc. India Rhode Island

approach uses the same orthogonal methods utilized to identify and assess potentially immunogenic impurities for the FDA. The approach is described in a  review titled "Immunogenicity Risk Assessment of Synthetic Peptide Drugs and Their Impurities." The details of one of the FDA-contracted programs were expanded upon in, "Assessing the Immunogenicity Risk of Salmon Calcitonin Peptide Impurities Using In Silico and In Vitro Methods."

EpiVax looks forward to executing this latest FDA-funded research in collaboration with CUBRC and continuing to improve access to safe and effective generic peptide drug products by leading in the development of new industry standards for generic peptide drug immunogenicity assessment.

About EpiVax
EpiVax is a leader in the industry of immunogenicity assessment and sequence optimization for peptide therapeutics, biologic therapeutics, and vaccines. EpiVax partners with a global roster of companies, agencies, and academics to accelerate immunogenicity risk assessment, immune modulation and rapid vaccine design. Visit www.epivax.com for 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.org for 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 (~$2M) will be financed with federal money.

Press Contact
Sarah Moniz
Director, Business Development
EpiVax
[e-mail]

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