PartnershipMay 18, 2026, 05:26 PM
ImmunityBio secures exclusive US rights for Tokyo-172 BCG strain
AI Summary
ImmunityBio entered an exclusive development and supply agreement with Japan BCG Laboratory for the Tokyo-172 strain of Bacillus Calmette-Guerin (BCG) for the U.S. market. This aims to address the decade-long BCG shortage for high-grade non-muscle invasive bladder cancer (NMIBC) patients. The agreement grants ImmunityBio exclusive U.S. rights for 10 years post-FDA approval, with no upfront payments. The Tokyo strain demonstrated non-inferior efficacy to TICE BCG in the NCI-sponsored SWOG S1602 Phase III trial, with a 5-year high-grade recurrence-free survival of 64% for Tokyo vs. 58% for TICE. This provides ImmunityBio a second potential BCG source, alongside its existing rBCG partnership.
Key Highlights
- ImmunityBio secured exclusive U.S. development and supply rights for Tokyo-172 BCG.
- Agreement with Japan BCG Laboratory is for 10 years post-FDA approval, with no upfront payment.
- Tokyo-172 BCG showed non-inferior efficacy to TICE BCG in Phase III SWOG S1602 trial.
- High-grade recurrence-free survival (HGRFS) HR 0.82 (95.8% CI 0.63–1.08).
- Estimated 5-year HGRFS was 64% for Tokyo arm vs. 58% for TICE arm.
- ImmunityBio will be the sole BLA applicant and commercializer in the U.S.
- This provides a second potential BCG source to address U.S. supply needs.
Price Impact
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