Reported Saturday, ImmunityBio Secures Exclusive US Rights To Tokyo-172 BCG After Phase 3 Trial Shows Non-Inferior Efficacy To TICE BCG

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  • Positive Phase III readout of National Cancer Institute-sponsored SWOG S1602 randomized clinical trial demonstrating non-inferior efficacy of the Tokyo strain of BCG (Tokyo-172 BCG) versus TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer
  • ImmunityBio to serve as sole U.S. Biologics License Application applicant for the Tokyo strain of BCG and plans to engage with U.S. Food and Drug Administration (FDA) on regulatory pathway to address the over decade long unresolved BCG shortage in the United States
  • Agreement positions ImmunityBio with second potential BCG source to help address U.S. supply needs
  • Through ImmunityBio's ongoing partnership with Serum Institute of India, recombinant BCG (rBCG) remains available to eligible patients under ImmunityBio's FDA Expanded Access Program
  • Details of the Japan BCG Laboratory agreement will be shared during Dr. Patrick Soon-Shiong's presentation at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, on May 16, 2026 at 1:30 p.m. EDT. A link to the livestream is included below.
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