Page 56 - Binder2

The focus was on immediate efficacy—on measurable
response in the first 8 to 12 weeks, on endpoints that could
pass Phase III trials, on effects strong enough to secure
FDA approval and insurance coverage.

Long-term immune compatibility? That was someone
else’s problem—or more often, no one’s.

Immunogenicity was known, yes. Scientists were aware
that large proteins made in foreign systems could provoke
immune responses. But in the rush to bring powerful new
therapies to market, those risks were often downplayed,
compartmentalized, or considered manageable after the
fact. Tolerization—the slow, silent immune rejection of
these therapies—wasn’t a design priority. It was treated as
background noise.

Biologics were hailed as precision medicine, and in many
ways they were. But they were also blunt instruments—
immune-disrupting molecules delivered in unnatural ways,
often bypassing the body’s built-in tolerance pathways.

And yet they worked—brilliantly, in many cases. Patients
who had exhausted all options suddenly found relief.
Quality of life improved. Hospitals emptied. A new era in
medicine had begun.

But what we didn’t realize—what we didn’t account for—
was that this era came with an expiration date. And for
many patients, that date would come sooner than anyone
admitted. Not because the disease changed. Not because the
drug was flawed. But because the immune system, left
undirected, would eventually decide: this molecule does not
belong here.

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