Page 364 - Binder2

cold-chain-free, and built to endure—not just metabolically,
but immunologically.

Despite these achievements and NIH funding, no major
pharmaceutical company stepped in. The program moved
forward under academic leadership, outside the purview of
a system unwilling to upend its own infrastructure.

Oral Tolerance for Hemophilia: A Second Front

While the insulin program was the first to reach human
trials, an equally significant collaboration between Dr.
Daniell and Zea Biosciences focused on another high-
stakes challenge: hemophilia A.

Patients with hemophilia A lack Factor VIII, a clotting
protein, and rely on frequent injections of recombinant
FVIII to prevent bleeding. But up to 30% of these patients
develop inhibitory antibodies—immune responses that
render the therapy ineffective and life-threatening.

Dr. Daniell’s solution? Use lettuce chloroplasts to express
key epitopes of Factor VIII and deliver them orally. The
bioencapsulated FVIII fragments were designed not to
replace therapy, but to teach the immune system to stop
attacking it.

The approach:

● Trains mucosal immune cells to recognize FVIII as
non-threatening
● Increases Treg induction
● Suppresses inhibitor formation before it starts

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