Page 156 - Binder2

In a tolerance-first biotech, immune modeling is present
at the beginning:

• Antigen selection incorporates predictive ADA risk
and self-similarity screening
• Platforms are chosen based not just on expression
yield, but on immune signal minimization
• Protein engineering focuses as much on
acceptability as on potency—glycosylation
profiles, epitope shielding, Fc region design

From Day 1, every decision is run through a single lens:
Will the immune system allow this to stay?

2. Preclinical Development That Trains, Not Just
Tests

The standard preclinical flow asks:

• Does the drug bind the target?
• Does it show efficacy in disease models?
• Is it safe at escalating doses?

A tolerance-focused pipeline asks:

• Does the drug engage tolerogenic pathways?
• Does it induce or preserve regulatory T cells in
early exposure windows?
• Does it avoid activation of dendritic cells in danger-
associated contexts?

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