Pertussis Challenge Model.Hvivo is the only company that has it.25 Mar 2026 11:12
So Iliad are tied to Hvivo to get it done.
A competitor would have to start from scratch with a "Characterization Study" to prove to regulators (like the FDA or MHRA) that their specific strain of B. pertussis is safe, predictable, and effective at inducing the disease in humans.
This is why hVIVO has such a massive moat for this ILiAD contract:
Dose-Finding (6–12 months): A new company has to test various "titrations" (strengths) of the bacteria on small groups of volunteers to find the exact dose that causes colonization without making people dangerously ill.
GMP Manufacturing (6–12 months): They must manufacture the "challenge agent" (the bacteria) under Good Manufacturing Practice (GMP) standards, which requires specialized facilities and rigorous stability testing to ensure it doesn't change over time.
Regulatory Review: Each of these steps requires its own clinical trial application and safety data review before a "Pivotal" Phase 3 could even be discussed.
For ILiAD, waiting 2 years for a competitor to build a model would destroy their 2027 goal and burn through their $115 million in "lights-on" costs. They are effectively tethered to hVIVO for this trial.