, /PRNewswire/ – EpiVax, Inc., with U.S. Food and Drug Administration (FDA) and CUBRC, Inc. (Buffalo, NY) scientist collaborators, announces the publication of a study titled "Immunogenicity Risk Assessment of Peptide-Related Impurities Identified in Generic Teriparatide Products." The study uses a series of different tools to evaluate whether peptide-related impurities may influence unwanted immune responses in generic teriparatide (TPT)—an important consideration for ensuring the safety and comparability of generic peptide drugs.

Teriparatide, a recombinant peptide used to treat osteoporosis, is among the peptide products highlighted in a recent FDA guidance that recommends that applicants assess immunogenicity risk for synthetic generics submitted under an abbreviated new drug application (ANDA). While establishing active pharmaceutical ingredient sameness is a key regulatory requirement, impurities arising from manufacturing processes may introduce sequence changes with the potential to generate new "T-cell epitopes".

The study systematically evaluates teriparatide and several theoretical or observed impurities using the orthogonal methods of EpiVax’s PANDA approach: in silico assessment (leveraging T-cell epitope prediction and characterization tools, EpiMatrix® and JanusMatrix®), in vitro HLA binding assays, and human T-cell assays.

The investigators identified multiple impurities with higher predicted immunogenic potential than the reference teriparatide sequence, using the computational tools. Experimental analyses corroborated these predictions, revealing enhanced HLA binding and T-cell responses for several impurities compared to teriparatide itself. Notably, the study revealed a potentially tolerogenic region within the teriparatide sequence that may reduce responses to the drug, but that could be disrupted by sequence changes in the impurities.

"This collaboration with FDA scientists underscores the power of combining robust computational and wet-lab methods to better understand and mitigate immunogenicity risks in generic peptide development," said Dr. Vibha Jawa (CSO, EpiVax). "Our findings offer a practical framework for developers navigating the FDA guidance on impurity assessment and highlight opportunities to strengthen peptide drug safety."

The study may help generic peptide manufacturers identify impurities of concern that would contribute to immunogenicity and thus should be controlled in the generic drug product.

**FDA Funding Statement **The research described was performed by EpiVax in collaboration with CUBRC, Inc. and FDA contributors, supported by FDA contract HHSF223018186C. The contents of this release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

**Press Contact: **Sarah Moniz Director, Business Development [email protected]

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