EpiVax and CUBRC win $1M FDA contract to establish best practices for assessing generic peptide drugs

EPIVAX AND CUBRC have been awarded a two-year, $1 million federal contract from the U.S. Food and Drug Administration to establish best practices and procedures for assessing generic peptides and related impurities for immunogenic potential. EpiVax CEO and Chief Science Officer Dr. Anne S. De Groot said generic peptides drugs are a quickly growing market. / PBN FILE PHOTO/MICHAEL SALERNO
EPIVAX AND CUBRC have been awarded a two-year, $1 million federal contract from the U.S. Food and Drug Administration to establish best practices and procedures for assessing generic peptides and related impurities for immunogenic potential. EpiVax CEO and Chief Science Officer Dr. Anne S. De Groot said generic peptides drugs are a quickly growing market. / PBN FILE PHOTO/MICHAEL SALERNO

PROVIDENCE – EpiVax Inc. and CUBRC Inc. have been awarded a two-year, $1 million federal contract from the U.S. Food and Drug Administration to establish best practices and procedures for assessing generic peptides and related impurities for immunogenic potential, EpiVax announced Tuesday.

EpiVax CEO and Chief Science Officer Dr. Anne S. De Groot told PBN that the project will involve EpiVax using its immunogenicity risk assessment expertise in the growing field of generic peptides to find impurities that could cause unexpected immune responses following the administration of a generic peptide drug, such as insulin, glucagon, ACTH and calcitonin, among others.

De Groot noted that while EpiVax has been in the immunogenicity risk assessment field for more than 15 years, the company has not yet applied its tools to generic peptides.

“EpiVax has worked hard to be at the forefront of immunogenicity assessment using our proprietary immunoinformatics tools. These 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,” De Groot said in a statement Tuesday.

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In a guidance on peptide drugs, the FDA noted that impurities in a generic peptide drug that imitates a previously approved drug could affect the safety or effectiveness of the generic drug, while other impurities could be acceptable and not affect the effectiveness nor the safety of a particular drug.

The newly-funded project will use computer-driven tools to expedite the identification of impurities – which could be missing amino acids, unintentionally inserted amino acids or duplicated amino acids – so that lab work may focus on problematic impurities, De Groot said.

The grant is overseen by the FDA’s Office of Generic Drugs, which will also have access to EpiVax’s Interactive Screening and Protein Reengineering Interface Toolkit for selected peptide drugs and their impurities.

The companies said that CUBRC, which is based in Buffalo, N.Y., will leverage its expertise in biomedical and research development as well as its experience in leading large federal government grants and contracts to execute the research in conjunction with EpiVax.

“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 to Katie Edwards, CUBRC’s prime technical program lead.

De Groot noted that the project falls under FDA director Scott Gottlieb’s mandate to apply new technologies to improve the safety profile of drugs used by patients.

Chris Bergenheim is the PBN web editor. Email him at Bergenheim@PBN.com.