PROVIDENCE, RI, August 10, 2023 /PRNewswire/ — EpiVax Inc. announces the publication of results from a research collaboration with the Food and Drug Administration aimed at streamlining generic drug evaluations. The research, initiated in 2018 with a $1M contract spanning two years (HHSF223018186C), was established to develop best practices for assessing the immunogenic potential of active pharmaceutical ingredients and their impurities for filing Abbreviated New Drug Applications (ANDAs). Additional funding of $1.1M was secured for this program in 2020 (75F40120C00157). The results of the preclinical assessment initiative are now published in “Drug Discovery Today” titled, “Immunogenicity Risk Assessment of Synthetic Peptide Drugs and Their Impurities.”
The collaboration was triggered by a draft guidance for generic peptide ANDAs released in 2018, which was later finalized in 2021 (FDA-2017-D-5767). This guidance underscores the significance of identifying and characterizing any key impurities present in a drug’s formulation before approval. Particularly, it suggests new or “higher level” impurities that differ from those in the reference listed drug undergo assessment to determine if they introduce new T cell epitope content to the product. A Broad Agency Announcement invited potential collaborators to explore these assessments 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 vaccine and biologics assessment, to evaluate the immunogenicity of generic drug impurities. The publication outlines EpiVax’s recommended “PANDA” approach, featuring case studies.
Since 2018, EpiVax’s scientists have garnered extensive experience in supporting drug manufacturers with immunogenicity assessments for ANDA submissions to various global regulatory agencies.
Thankful for the opportunity to make an impact in this domain, the EpiVax team anticipates future opportunities to develop their expertise and offerings as the generic peptide market continues to grow. As patents for over 80 approved peptide drugs approach expiration and open the door for generics, EpiVax stands ready to play a role in this expanding landscape.
EpiVax is a 25-year-old biotechnology company located in Providence, RI. Scientists at EpiVax, are identified as leaders in the field of immunogenicity assessment of vaccines and biologics. EpiVax partners with a global roster of companies, agencies, and academic collaborators to further research in the immunogenicity space, as applied to autoimmunity, infectious diseases, cancer and beyond.
Assoc. Director, Business Development