EpiVax Strengthens Technology Leadership Amid Immunoinformatics Advancements

In addition, EpiVax has filed a new Model Master File (MMF) for its PANDA® In Silico Model to the FDA, supporting regulatory filing of Abbreviated New Drug Applications (ANDA) of generic peptide drugs. EpiVax's PANDA® MMF provides detailed descriptions of its models and methodologies for assessing the immunogenicity of peptide drugs and their impurities and can now be referenced as a Drug Master File (DMF) in FDA ANDA fillings. The accessibility of EpiVax's PANDA® MMF represents an important step in streamlining the preparation and review of ANDAs, enabling sponsors to simplify their regulatory package and FDA reviewers to access in-depth background and validation information regarding  EpiVax's immunogenicity models.

In addition, EpiVax has filed a new Model Master File (MMF) for its PANDA® In Silico Model to the FDA, supporting regulatory filing of Abbreviated New Drug Applications (ANDA) of generic peptide drugs. EpiVax's PANDA® MMF provides detailed descriptions of its models and methodologies for assessing the immunogenicity of peptide drugs and their impurities and can now be referenced as a Drug Master File (DMF) in FDA ANDA fillings. The accessibility of EpiVax's PANDA® MMF represents an important step in streamlining the preparation and review of ANDAs, enabling sponsors to simplify their regulatory package and FDA reviewers to access in-depth background and validation information regarding  EpiVax's immunogenicity models.

EpiVax remains committed to driving innovation with several planned improvements for the ISPRI platform upcoming, including a new version of EpiMatrix® to further enhance the toolkit's predictive capabilities. Additionally, guided analysis features and an updated user interface for ISPRI will provide a more user-friendly experience, empowering our partners in strengthening their pipelines.

About EpiVax
EpiVax is a leader in preclinical immunogenicity assessment and sequence optimization for peptide therapeutics, biologic therapeutics, and vaccines. EpiVax partners with a global roster of companies, agencies, and academics to accelerate immunogenicity risk assessment, immune modulation, and rapid vaccine design.

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

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