PROVIDENCE, R.I., Dec. 29, 2020 /PRNewswire/ — EpiVax, Inc. (“EpiVax”) today provides an update on the advancement of the company’s peptide therapeutic immunogenicity assessment program.
The PANDA (Peptide Abbreviated New Drug Application) immunogenicity assessment program was originally developed for screening generic peptide drugs and their impurities following the publication of the ANDA draft guidance by the Food and Drug Administration (FDA). EpiVax performed validation studies of the in silico tools and in vitro validation methods used in the PANDA program in collaboration with CUBRC under contract to the FDA between 2018 and 2020. Work performed by EpiVax under this initial FDA contract is in preparation for publication. Meanwhile, EpiVax announced a new FDA OGD contract in October 2020.
In parallel with the contracted PANDA peptide immunogenicity research, EpiVax has seen its peptide immunogenicity screening services increase, growing as a source of commercial revenue to almost twenty percent of total revenue between 2017 and 2020. In the past 12 months, EpiVax worked with over fifteen pharmaceutical and biotechnology companies developing both novel and generic peptide therapeutics, applying in silico screening, HLA binding assays, and T cell assays to assess the immunogenic risk of their products utilizing the PANDA approach.
EpiVax’s CEO/CSO, Annie De Groot, MD, says, “Having performed protein immunogenicity risk assessment for more than 20 years, we’re thrilled to not only be able to add immunogenicity risk assessment of generic peptides and their impurities to our repertoire of services, but also to see the PANDA approach becoming increasingly useful for assessing the potential immunogenicity of novel peptide therapeutics. The application of our PANDA research aims to help peptide drug developers reduce the risk of failure in the clinical phase of development. We look forward to learning more about the immunogenicity of generic and novel peptide therapeutics and growing our program further in 2021.”
For more information about non-clinical immunogenicity assessment for generic peptide products, register for the FDA’s Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling webinar on January 26, 2021.
EpiVax is a biotechnology company with expertise in immunoinformatics, immune modulation, and rapid vaccine design. EpiVax’s immunogenicity screening toolkits for therapeutics and vaccines, ISPRI and iVAX, are employed by EpiVax scientists and developers that work in globally distributed Pharma companies.
For more information about EpiVax and the PANDA program, visit www.epivax.com.
Katie Porter, Business Development Manager
SOURCE EpiVax Inc.
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