ImmunityBio Inc. (NASDAQ:IBRX) on Monday said it entered an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory to develop, import, and commercialize the Tokyo strain of BCG for bladder cancer treatment in the U.S.

ImmunityBio Secures Exclusive Rights To Tokyo-Strain BCG

The agreement gives ImmunityBio exclusive U.S. rights to intravesical Tokyo-172 BCG, an investigational therapy that has not yet received Food and Drug Administration (FDA) approval.

The company said the partnership follows positive Phase 3 data from the SWOG S1602 trial, sponsored by the National Cancer Institute, which showed the Tokyo strain was non-inferior to TICE BCG in patients with BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC).

ImmunityBio will 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