EpiVax, Inc. ("EpiVax") and CUBRC, Inc. ("CUBRC") announce that they have been awarded a two-year, $2 million contract (#75F40124C00094) from the Office of Generic Drugs (OGD) of the Food and Drug Administration (FDA) to develop standardized controls for T cell assays performed to assess the immunogenicity risk of generic drugs in support of ANDA applications as outlined in the relevant FDA guidance. The new contract will establish new "standards" that may be used to enhance specificity and sensitivity across industry assay methods.

Generic peptide drugs (including generic versions of well-known brands like Ozempic and Wegovy) play a vital role in improving healthcare access by providing affordable and effective treatment options at a lower cost. FDA has been working to facilitate access to needed medicines at lower costs without sacrificing  standards that result in high-quality, safe, and effective medications. See, for example, information provided by the FDA here.

The new FDA-funded collaboration builds on research performed by EpiVax during two previous FDA contracts that evaluated the immunogenicity risk of generic drug impurities. Under the first contract, EpiVax demonstrated the value of in silico and in vitro methods for immunogenicity risk assessment of two well-known generic peptide drugs. Under the second contract, EpiVax developed the What-if Machine (WhIM), an algorithm designed to perform iterative modifications to the amino acid sequence of a synthetic peptide drug (in silico), generating a comprehensive list of impurities for that sequence, and prospectively identifying high and low risk impurities to allow for the de-risking of drug products. This information helps to 'frame' the risk for each generic drug and may assist drug developers and FDA reviewers to differentiate impurities that are potentially riskier  from those that are lower risk.

For the latest research program, EpiVax will identify and qualify standard peptide-sized positive and negative controls to support generic peptide drug ANDA applications for common generic drug peptides such as teriparatide, exenatide, liraglutide and tirzepatide. EpiVax's Peptide Abbreviated New Drug Application (PANDA®) 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.