Page 127 - Binder2

1. Immunogenicity Tracking Must Be
Standardized, Frequent, and Central

Today, immunogenicity data—specifically ADA
formation—is inconsistently measured and inconsistently
reported. Some trials test only for binding antibodies.
Others assess neutralizing antibodies. Some measure at
baseline and Week 12; others omit post-induction data
entirely.

To take immune tolerance seriously, ADA surveillance
must become a core trial metric, not a checkbox.

Previously we discussed the FDA’s guidance on ADAs.
This is a step in the right direction, but to create an accurate
and equitable assessment expansion needs to occur.

Key Principle Description
ADA (anti-drug antibody)
formation is not static and can arise
unpredictably over time. Relying
only on early or predefined
Frequent Testing endpoints risks missing important
Throughout the immune responses. Regular, high-
Study
resolution ADA sampling enables
better understanding of the
biologic-immune system
interaction.

Short-term windows (e.g., 12–24
Longitudinal weeks) may capture initial efficacy
Tracking of ADA but miss later ADA emergence,
Over Time which often lags behind. Patients
may lose response months after

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