PROVIDENCE, R.I., Aug. 11, 2023 /PRNewswire/ — EpiVax Inc. announces the publication of the results of a research collaboration with the Food and Drug Administration aimed at optimizing generic drug evaluations. The research, initiated in 2018 with a $1 million contract spanning two years (HHSF223018186C), was established to develop best practices for evaluating the immunogenic potential of active pharmaceutical ingredients and their impurities for abbreviated new drug applications ( GO). Additional funding of $1.1 million has been secured for this program in 2020 (75F40120C00157). The results of the preclinical evaluation initiative are now published in “Drug Discovery Today” under the headline, “Immunogenicity Risk Assessment of Synthetic Peptide Drugs and Their Impurities.”
The collaboration was prompted by a draft guidance for ANDA of generic peptides published in 2018, which was later finalized in 2021 (FDA-2017-D-5767). This guideline underscores the importance of identifying and characterizing any key impurities present in a drug formulation prior to approval. In particular, it suggests that new or “higher level” impurities that differ from those of the reference listed drug undergo evaluation to determine whether they introduce new T-cell epitope content into the product. A broad announcement from the agency invited potential collaborators to explore these evaluations with the agency. EpiVax’s expertise in T-cell immunogenicity positioned the company as a competitive candidate for this project.
Throughout the program, EpiVax adapted in silico and in vitro immunogenicity risk assessment methods, previously leveraged for the evaluation of vaccines and biologics, to assess the immunogenicity of generic drug impurities. The publication describes the “PANDA” approach recommended by EpiVax, with case studies.
Since 2018, EpiVax scientists have gained extensive experience supporting drug manufacturers with immunogenicity assessments for ANDA submissions to various global regulatory agencies.
Grateful for the opportunity to make an impact in this domain, the EpiVax team anticipates future opportunities to build on its expertise and offerings as the generic peptide market continues to grow. As patents for more than 80 approved peptide medicines near expiration and open the door to generics, EpiVax is poised to play a role in this expanding landscape.
About EpiVax:
EpiVax is a 25-year-old biotechnology company located in Providence, Rhode Island. EpiVax scientists are identified as leaders in the field of immunogenicity assessment of vaccines and biologics. EpiVax partners with a global list of companies, agencies, and academic collaborators to further research in the immunogenicity space, as it applies to autoimmunity, infectious disease, cancer, and more.
Press Contact:Sarah MonizAssociate Director, Business DevelopmentSmoniz@epivax.com
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