EpiVax Enhances Technological Leadership with Immunoinformatics Advances

EpiVax Strengthens Its Position in Immunoinformatics

EpiVax, Inc., a leader in the evaluation of immunogenicity for peptide therapies, is making headlines with the recent appointment of Guilhem Richard as Chief Technology Officer (CTO). Dr. Richard, who joined EpiVax's immunoinformatics team in 2014, brings a wealth of experience to this role, including leading the development of a personalized cancer vaccine platform based on neoantigens known as Ancer®.

In his previous role between 2019 and 2024, he managed translational efforts for EpiVax Therapeutics, Inc., demonstrating his capability to steer innovative endeavors in biotechnology. In his new position, Dr. Richard will oversee EpiVax's innovation initiatives, focusing on the development of new and improved computational tools for assessing immunogenicity. His impressive academic background includes a Master's degree in bioinformatics from the National Institute of Applied Sciences (INSA) in Lyon, France, and a Ph.D. in bioinformatics from Boston University.

Major Technological Advancements

Dr. Richard's elevation comes at a pivotal time as EpiVax reports numerous significant advancements in its technology landscape and offerings. The company has revealed notable updates that leverage sophisticated artificial intelligence (AI) and machine learning (ML) techniques for several key immunoinformatics assets integrated into their ISPRI platform. These enhancements are set to improve the immunogenicity risk assessment functionalities, a critical element for developing biological therapeutic products.

EpiVax researchers have refined the prediction of tolerated epitopes by 50%, resulting in increased accuracy and recall of their JanusMatrix model. Additionally, innovative immunogenicity models predicting anti-drug antibody (ADA) rates for monoclonal therapeutic products have shown a remarkable six-fold improvement in correlation between predicted and observed values compared to existing methodologies. Furthermore, the updated tools significantly reduce false negative rates, highlighting a decrease of 85% in cases of low predicted immunogenicity alongside high observed immunogenicity.

These advanced tools will soon be accessible on EpiVax's ISPRI platform, which is available as a Software as a Service (SaaS) model, offering pay-per-use functionalities in the upcoming months. This will bolster the precision of results during a crucial evaluation step in the development process for clients and collaborators within the global biotechnology and pharmaceutical sectors.

New Model Master File and Regulatory Goals

In addition to technological improvements, EpiVax has submitted a new Model Master File (MMF) for its in silico PANDA® model to the FDA. This submission aims to facilitate the filing of Abbreviated New Drug Applications (ANDAs) for peptide-based generic drugs. The PANDA® MMF provides comprehensive descriptions of its models and methodologies for assessing the immunogenicity of peptide drugs and their impurities, and it can now be referenced as a Drug Master File (DMF) in the FDA's ANDA filings.

The availability of the PANDA® MMF marks a significant milestone in streamlining the preparation and review processes for ANDAs, allowing sponsors to simplify their regulatory filing and enabling FDA reviewers to access in-depth background and validation information regarding EpiVax's immunogenicity models.

Commitment to Innovation

EpiVax remains committed to fostering innovation, with various enhancements planned for the ISPRI platform, including an upcoming version of EpiMatrix® designed to further augment predictive capabilities. Additionally, guided analytics features and an updated user interface for ISPRI will provide a more user-friendly experience, enabling partners to strengthen their pipelines effectively.

About EpiVax

EpiVax is renowned for its expertise in preclinical immunogenicity assessment and optimization of sequences for peptide therapies, biological therapies, and vaccines. By partnering with companies, agencies, and academic institutions globally, EpiVax aims to accelerate immunogenicity risk assessments, immune modulation, and the rapid design of vaccines.

For media inquiries, please contact:
Sarah Moniz
Business Development Director
EpiVax
Email: [email protected]