ImmunityBio Secures Exclusive U.S. Rights to Tokyo-172 BCG After HR 0.82 Phase III Readout
ImmunityBio secured exclusive U.S. rights to develop, import and commercialize the Tokyo-172 BCG strain under a new agreement with Japan BCG Laboratory. This strain showed non-inferiority to TICE BCG in Phase III SWOG S1602 (HR 0.82; 95.8% CI 0.63–1.08) and creates a second supply source to address U.S. BCG shortages.
1. Agreement Details
ImmunityBio entered an exclusive U.S. development and supply agreement with Japan BCG Laboratory granting exclusive rights to develop, import and commercialize intravesical Tokyo-172 BCG for high-grade non-muscle invasive bladder cancer.
2. Phase III SWOG S1602 Results
The Tokyo-172 strain demonstrated non-inferiority to TICE BCG in the Phase III SWOG S1602 trial (HR 0.82; 95.8% CI 0.63–1.08), with 5-year high-grade recurrence-free survival of 64% versus 58% for TICE.
3. Regulatory and Commercial Strategy
ImmunityBio will lead all FDA interactions, BLA submissions and future commercialization as the sole marketing authorization holder upon approval, aiming to secure U.S. approval for the Tokyo strain.
4. Supply Partnerships
The new agreement establishes a second BCG supply alongside ImmunityBio’s recombinant BCG collaboration with the Serum Institute of India, addressing a decade-long shortage in the U.S. market.