Publication in Frontiers in Immunology

We are proud to celebrate a new publication from our team, in collaboration with Regeneron Pharmaceuticals.

Congratulations to Lisette M. Fred Lucena, Ph.D., Associate Director and Head of Project Management at Immunologix Laboratories, and the full team at Regeneron, Jenny L. Valentine, Stacey Shank, Zhiqiang Wang, Colleen McLaughlin Stern, Byung Chul Kim, Kun Lu, Saileta Prabhu, and Michael A. Partridge, on the publication of their work in Frontiers in Immunology.

📄 “Immunogenicity assessment for vidutolimod: a risk-driven approach for a simplified 1-tiered, singlicate anti-drug antibody testing strategy”

This paper tackles a question that is increasingly relevant as the therapeutic landscape expands beyond traditional biologics: when the standard 3-tiered ADA testing paradigm was developed for a very different class of molecules, does it still serve programs built around novel modalities?

For vidutolimod, a virus-like particle therapeutic with a mechanism of action that requires a robust ADA response, the answer was no. A thorough immunogenicity risk assessment led the team to design and validate a simplified 1-tiered, singlicate testing strategy, one that was fit for purpose for the clinical program rather than retrofitted from convention.

The work is a strong example of what risk-driven bioanalytical thinking looks like in practice: letting the biology inform the strategy, not the other way around.

Read the full open-access paper: https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2026.1751717/full