ImmunityBio Inc. (NASDAQ: IBRX) announced an exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo strain of BCG, aimed at addressing the chronic BCG shortage in the United States that has persisted for over a decade.

The agreement provides ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG. The company will serve as the sole Biologics License Application applicant and plans to engage with the Food and Drug Administration on the regulatory pathway.

The Tokyo strain is supported by positive Phase III results from SWOG S1602, a randomized study sponsored by the National Cancer Institute that enrolled 984 eligible patients with BCG-naïve high-grade non-muscle invasive bladder cancer. The study demonstrated non-inferiority of the Tokyo strain versus TICE BCG, with a hazard ratio of 0.82 and a 95.8% confidence interval of 0.63–1.08, well below the pre-specified non-inferiority margin of 1.34.

At a median follow-up of 4.6 years, the estimated 5-year high-grade recurrence-free survival was 64% in the Tokyo arm compared to 58% in the TICE arm. Complete response in carcinoma in situ at 6 months was 66.4% for Tokyo versus 70.2% for TICE.

The Tokyo strain of BCG has been used in Japan for almost 30 years for treating high-risk non-muscle invasive bladder cancer but remains investigational in the United States and has not been approved by the FDA.

This agreement gives ImmunityBio a second potential BCG source alongside its ongoing partnership with Serum Institute of India for recombinant BCG, which remains available to eligible patients under the company's FDA Expanded Access Program.

ImmunityBio is in discussions with the SWOG Cancer Research Network, the National Cancer Institute, and Fred Hutchinson Cancer Research Center to establish a Data Use Agreement for incorporating S1602 data into its planned BLA submission.