#USA #FDA #EpiVax #Providence, RI #Teriparatide

New Study by EpiVax and FDA on Immunogenicity Risks

EpiVax, Inc. has announced groundbreaking research in conjunction with scientists from the U.S. Food and Drug Administration (FDA) and CUBRC, Inc. This study, titled "Immunogenicity Risk Assessment of Peptide-Related Impurities Identified in Generic Teriparatide Products," explores significant immunogenicity risks linked to peptide impurities found in generic Teriparatide formulations. Teriparatide, a synthetic peptide used in osteoporosis treatment, is part of the FDA's recent guidance mandating that applicants assess the immunogenicity risks associated with synthetic generics under a shortened approval process called Abbreviated New Drug Application (ANDA).

In the pharmaceutical landscape, ensuring the comparability of drug substances is paramount, especially as manufacturing processes can introduce various impurities that may alter peptide sequences. These changes could lead to the generation of new T-cell epitopes, which can trigger unwanted immunological responses. The study examines Teriparatide alongside different theoretical or observed impurities using a robust range of methodologies. This includes EpiVax's PANDA approach for in-silico evaluations, complemented by in vitro HLA binding assays and human T-cell assays.

Through this multi-faceted evaluation, the research team identified numerous impurities that exhibited a higher predicted immunogenic potential compared to the reference Teriparatide sequence. Experimental analyses underpin these predictions, revealing enhanced HLA binding and T-cell activation across several of these impurities as compared to Teriparatide. Notably, the team discovered a possibly tolerogenic region within the Teriparatide sequence, which could minimize immune responses; however, alterations caused by various impurities could disrupt this tolerance.

Dr. Vibha Jawa, Chief Scientific Officer at EpiVax, emphasized the importance of this collaboration. She stated, “This work highlights the advantages of integrating robust computational tools with practical lab techniques to better understand and mitigate immunogenicity risks in generic peptide development.” The findings offer a valuable framework for drug developers to align with the FDA's guidelines concerning the assessment of impurities, thereby facilitating improved safety measures for peptide-based medications.

The implications of this study resonate deeply within the pharmaceutical manufacturing sector, as it enables generic peptide producers to pinpoint concerning impurities that may contribute to immunogenic reactions. Consequently, it raises the stakes for quality control within the production of generic medicines. EpiVax's commitment to advancing science while sustaining pharmaceutical safety standards underlines the critical nature of these findings.

This initiative is backed by funding from the FDA, confirming the regulatory body’s involvement in enhancing the safety and efficacy of peptide drugs. Importantly, while the conclusions drawn in this statement represent the authors’ insights, they do not necessarily reflect the official positions of the FDA or the U.S. government.

Conclusion

As EpiVax continues to pave the way for safer therapeutic options, the study serves as a significant milestone in the realm of biopharmaceuticals. It also presents an urgent call to action for manufacturers of generic peptides to enhance their understanding of impurities, ensuring the continued safety and efficacy of treatments available to patients worldwide.