Office of Generic Drugs (OGD/FDA) Awards $1M FDA Contract to CUBRC and EpiVax for Demonstration and Validation of Immunogenicity Risk Assessment

PROVIDENCE, Rhode Island, Oct. 2, 2018 /PRNewswire/ -- EpiVax, Inc. ("EpiVax") and CUBRC, Inc. ("CUBRC") announced today that they have been awarded a two-year $1 million contract from the Food and Drug Administration (FDA) in response to a Broad Agency Announcement (BAA), FDA BAA-17-00123.

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The research program will identify best practices and procedures for assessing generic peptides and related impurities for immunogenic potential. "EpiVax has worked hard to be at the forefront of the immunogenicity assessment field. Our proprietary immunoinformatics tools make it possible to perform risk assessments accurately and expeditiously. We look forward to working with FDA scientists to set new standards for immunogenicity risk assessment for generic peptide drug products," stated Annie De Groot, MD, EpiVax's CEO/CSO.

The FDA recently issued a draft guidance for generic peptide drugs and issued a BAA for immunogenicity risk assessment tools. In response to this BAA, EpiVax scientists will demonstrate and validate risk assessment methods for generic peptides. OGD scientists will also have access to the EpiVax ISPRI Toolkit for selected peptide drugs and their impurities.

CUBRC will leverage its technical expertise in biomedical research and development along with its experience leading large federal government grants and contracts in collaboration with EpiVax to execute the research. "CUBRC plans to leverage our 3+ year partnership with EpiVax to provide systems integration and program management expertise to advance EpiVax's highly specialized immunoinformatic tools which will help the FDA with evaluation of new generic peptide drugs," stated Katie Edwards, Ph.D., CUBRC's Prime Technical Program Lead.

About the Draft FDA Guidance on Generic Peptide ANDAs The new draft guidance issued by the Office of Generic Drugs highlighting the use of in silico analysis in accelerated new drug applications for generic peptide drugs can be found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) [https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578365.pdf].

About EpiVax EpiVax is a 20-year old privately-held biotechnology company located in Providence RI, with a broad portfolio of projects including vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. Scientists at EpiVax, led by co-founders Annie De Groot and Bill Martin, lead the field in immunogenicity risk assessment. The ISPRI [http://www.epivax.com/immunogenicity-screening/ispri-web-based-immunogenicity-screening/] and iVAX [http://www.epivax.com/vaccine-design-redesign/ivax-web-based-vaccine-design/] toolkits for therapeutics and vaccines are used by a global roster of companies. Visit www.epivax.com [http://www.epivax.com/] for more information.

EpiVax's spin-out company, EpiVax Oncology, is leveraging a peptide-driven approach to personalized cancer immunotherapy. Visit www.epivaxonco.com [http://www.epivaxonco.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 [http://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 (~$1.0M) will be financed with federal money.

Press Contact Annie De Groot, MD EpiVax, Inc. 401-272-2123 KNelson@EpiVax.com [mailto:KNelson@EpiVax.com]

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Web site: http://www.epivaxonco.com/

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