ImmunityBio has announced an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo strain of BCG (Tokyo-172 BCG), aiming to help address the long-standing BCG shortage in the United States for patients with high-grade non-muscle invasive bladder cancer (NMIBC).
The agreement follows positive Phase III results from the National Cancer Institute-sponsored SWOG S1602 clinical trial, which demonstrated that Tokyo-172 BCG achieved non-inferior efficacy compared to TICE BCG in BCG-naïve high-grade NMIBC patients. The study reported a hazard ratio of 0.82 (95.8% CI 0.63–1.08), remaining below the pre-specified non-inferiority margin of 1.34.
Under the agreement, ImmunityBio will hold exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG and plans to engage with the U.S. Food and Drug Administration (FDA) regarding the regulatory pathway. The Tokyo strain of BCG remains investigational in the United States and has not yet received FDA approval.
The SWOG S1602 Phase III trial enrolled approximately 1,000 patients with BCG-naïve high-grade NMIBC between 2017 and 2020. Results presented at the 2026 ASCO Genitourinary Cancers Symposium showed similar progression-free survival between Tokyo-172 BCG and TICE BCG, with estimated 5-year high-grade recurrence-free survival rates of 64% and 58%, respectively.
ImmunityBio also confirmed ongoing discussions with the SWOG Cancer Research Network, the National Cancer Institute, and Fred Hutchinson Cancer Research Center regarding use of the SWOG S1602 data in a future Biologics License Application (BLA).
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The agreement provides ImmunityBio with a second potential BCG source for the U.S. market alongside its ongoing partnership with Serum Institute of India for recombinant BCG (rBCG), which remains available to eligible patients through the company’s FDA Expanded Access Program.
“SWOG and the National Cancer Institute have our deep respect for designing and completing SWOG S1602, a randomized controlled trial of approximately one thousand patients in BCG-naïve high-grade NMIBC that took nearly a decade to read out,” said Patrick Soon-Shiong. “Its non-inferiority finding for the Tokyo strain of BCG, alongside our rBCG partnership with Serum Institute and the FDA-approved use of ANKTIVA® with BCG in BCG-unresponsive disease, points to a future where U.S. patients with bladder cancer will have the supply and treatment options they need.”
ImmunityBio’s FDA-approved ANKTIVA is currently indicated in combination with BCG for adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors.
