ImmunityBio signs exclusive U.S. supply agreement with Japan BCG Laboratory for Tokyo strain of BCG

ImmunityBio, Inc.

Agreement grants ImmunityBio exclusive U.S. rights to develop and commercialize Tokyo-172 BCG for 10 years after FDA approval.
Positive Phase III SWOG S1602 trial demonstrated non-inferiority of Tokyo strain vs TICE BCG in high-grade NMIBC (HR 0.82; 95.8% CI 0.63–1.08).
ImmunityBio plans to engage FDA for BLA submission as sole applicant; no payment due until FDA approval; vials for regulatory submission provided at no cost.
Agreement provides second BCG source alongside Serum Institute's rBCG; rBCG remains available to eligible patients under FDA Expanded Access Program.

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