The EpiVax team is dedicated to advancing the science of immunogenicity assessment and streamlining the preclinical drug development process for our partners worldwide. This month, we’re excited to share several updates with you, including new and updated in silico immunogenicity assessments (JanusMatrix, ADA prediction, Class I), regulatory advancements (a Model Master File to support client ANDA filings), leadership news (our new Chief Technology Officer), and upcoming events. 

AI & ML-Powered Enhancements in Immunogenicity Prediction

EpiVax has introduced significant updates to our in silico immunogenicity assessment toolkit, the ISPRI™ platform, integrating advanced AI and ML capabilities to refine immunogenicity risk assessment across therapeutic modalities by improving the accuracy of key models. 

EpiVax’s JanusMatrix model (which helps predict tolerated epitopes) has been significantly improved, increasing precision and recall by 50%. Additionally, more specific for antibody-based modalities, our latest ADA prediction models for monoclonal therapeutics have demonstrated a six-fold increase in correlation between predicted and observed anti-drug antibody (ADA) rates. These updates also reduce false negatives (cases where immunogenicity risk is underestimated) by an impressive 85%, providing drug developers with an even more reliable risk assessment framework. 

These enhanced tools will soon be available through the ISPRI™ platform, accessible via SaaS and fee-for-service options, helping biotech and pharma companies worldwide make more informed decisions to guide their preclinical R&D efforts. 

Improved Class I Immunogenicity Screening Capabilities 

We’ve just rolled out new ISPRI features to enhance HLA Class I immunogenicity screening! If you’re working with gene or cell therapies (therapies induced via mRNA, DNA-LNP, viral vectors) you know that assessing Class I risk is just as crucial as Class II. While CD8+ T cell responses can occur without CD4+ T cell help, a strong Class II response can still amplify Class I immunogenicity, making it critical to analyze both. 

We’ve expanded the Class I immunogenicity screening capabilities within the ISPRI™ toolkit, supporting developers working with these modalities. The updates provide a more comprehensive approach to predicting immunogenicity risks for these increasingly popular novel therapeutics. 

Key enhancements include improved screening tools with new reporting options and data visualizations. Examples are shown below: 

These updates enable biotech and pharma companies to better predict and mitigate immunogenicity risks in their early-stage pipeline, improving candidate selection and optimization. 

Join our upcoming webinar for a live demonstration of these new features! (Details below) 

What’s Next for ISPRI™?  

Innovation never stops at EpiVax. We’re constantly refining, expanding, and validating our tools to stay ahead in the ever-evolving world of biologic drug development. By listening to our partners and anticipating industry needs, we ensure our immunoinformatics solutions remain cutting-edge, reliable, and impactful.  

Here’s a sneak peek into advancements coming to the ISPRI™ toolkit next: 

• EpiMatrix® 2.0: A next-generation upgrade enhancing predictive accuracy for T cell epitope identification 

• Guided analysis features: Enabling users to more easily perform and interpret complex analyses with modality-specific guided access steps developed by computational immunology experts at EpiVax 

• A new user interface: Providing a more seamless and intuitive user experience.  

These updates will further empower our partners in making data-driven decisions that enhance the safety and effectiveness of their biologic therapeutics. 

PANDA® Model Master File (MMF) Filed with FDA 

EpiVax has officially filed a Model Master File (MMF) for the PANDA® In Silico Model with the FDA, marking a major step forward in streamlining regulatory filings for generic peptide drug developers.  

The PANDA® MMF is an FDA reference document that provides detailed descriptions of EpiVax’s models and methodologies for assessing the immunogenicity of peptide drugs and their impurities. Now, sponsors submitting Abbreviated New Drug Applications (ANDA) may opt to reference the PANDA® MMF as a Drug Master File (DMF) in their regulatory submissions to make this information with additional insights about the technology accessible to FDA reviewers. This milestone simplifies the approval process for generic drug developers. 

EpiVax Names Dr. Guilhem Richard as Chief Technology Officer 

We’re excited to announce that Guilhem Richard, PhD has been recently appointed as Chief Technology Officer (CTO) at EpiVax. Since joining our team in 2014, Dr. Richard has been instrumental in developing Ancer®, a personalized neoantigen-based cancer vaccine platform. From 2019 to 2024, he led the translational work of this technology.  

As CTO, Dr. Richard is now driving innovation across EpiVax’s computational immunology tools, overseeing the development of next-generation immunogenicity assessment technologies, many of which have been detailed above. His deep expertise in immunoinformatics will be key as we continuously expand and refine our platforms for the biopharma industry. 

Upcoming Webinar: Deep Dive into Class I Immunogenicity Assessment 

Date: March 12, 2025 | Time: 12:00 PM EST 

Join us for an in-depth look at the latest HLA Class I immunogenicity assessment tools and best practices. Featuring live case studies and a Q&A session with Dr. Annie De Groot and Aimee Mattei, this session is a must-attend for drug developers in gene and cell therapy. 

Registration is now closed.

Where in the World is EpiVax? 

We’re looking forward to connecting with you at upcoming industry events. Stop by our booths and check out our latest research! 

• Workshops on Recent Issues in Bioanalysis | New Orleans | April 7-11   

• Festival of Biologics | San Diego | April 23-24 | Booth #534 

• AAPS National Biotechnology Conference | Boston | May 4-7 | Booth #105 

• EpiVax’s own AI / HI & Immunoinformatics Workshop | Providence, RI | June 5-6  

• BIO International | Boston | June 16-19 | Rhode Island Pavillion  

See you there! 

Thank you for staying connected with EpiVax. 

We’re excited about the road ahead and can’t wait to continue working with you to advance immunogenicity science. Questions? We’d love to hear from you!