ImmunityBio, Inc. (NASDAQ:IBRX) has announced an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo strain of BCG (Tokyo-172 BCG).
The agreement grants ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG. The company will serve as the sole U.S. Biologics License Application applicant and Marketing Authorization Holder upon approval.
The Tokyo strain is supported by results from the SWOG S1602 Phase III clinical trial sponsored by the National Cancer Institute. The trial enrolled 984 eligible patients with BCG-naïve high-grade non-muscle invasive bladder cancer.
At a median follow-up of 4.6 years, the Tokyo strain demonstrated non-inferiority versus TICE BCG on high-grade recurrence-free survival, with a hazard ratio of 0.82.
ImmunityBio plans to engage with the FDA regarding the regulatory pathway for U.S. approval.
