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The question isn’t just, How do we get the drug into the
body?
It’s, How do we get the immune system to accept it?
4. A Clinical Strategy Built Around Immune
Memory
Traditional clinical trials for biologics are built to show fast
wins.
They prioritize symptom reduction over 8–12 weeks, get
the label, and let post-marketing data fill in the rest.
A tolerance-first biotech doesn’t chase speed for its own
sake.
It builds trials that capture immune durability:
• Longitudinal ADA tracking
• Sustained loss-of-response endpoints
• Treg/Th17 ratio monitoring
• Real-world follow-up built into Phase II extensions
The trial doesn’t just ask “Does it work?”
It asks “How long will it work—and what will make it
stop?”
5. Business, IP, and Regulatory Strategy Aligned
for Longevity
This shift is more than just scientific.
It touches every part of the business.
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