ImmunityBio (ImmunityBio (IBRX)) just made a big move in the bladder cancer space. On Monday, the company announced 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 United States. The goal? To finally address a BCG shortage that has plagued the U.S. for more than a decade.
The deal gives ImmunityBio exclusive U.S. rights to intravesical Tokyo-172 BCG, an investigational therapy that hasn't yet received FDA approval. But the company has some compelling data to back up its regulatory push.
Phase 3 Data Looks Promising
The partnership follows positive results from the SWOG S1602 trial, a Phase 3 study sponsored by the National Cancer Institute. The trial enrolled nearly 1,000 patients between 2017 and 2020, comparing the Tokyo strain to the standard TICE BCG in patients with BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC).
At a median follow-up of 4.6 years, the Tokyo strain met its primary endpoint of high-grade recurrence-free survival, showing a hazard ratio of 0.82 compared with TICE BCG—well below the pre-specified non-inferiority margin of 1.34. The estimated five-year high-grade recurrence-free survival rate was 64% in the Tokyo arm versus 58% in the TICE arm. Complete response rates in carcinoma in situ at six months were 66.4% for Tokyo BCG and 70.2% for TICE BCG.
ImmunityBio will serve as the sole U.S. Biologics License Application applicant for the Tokyo strain and plans to engage with the FDA on a regulatory pathway to address the long-standing BCG shortage.
Patents Bolster the Franchise
In a concurrent announcement on Monday, ImmunityBio said it secured five U.S. patents tied to the use of its IL-15 receptor agonist ANKTIVA with BCG for cancer treatment. The patents cover compositions, dosing regimens, treatment methods, and the commercial two-vial kit used in NMIBC, extending intellectual property protection for its bladder cancer franchise through at least 2035.
The company noted that the patent estate aligns with its new exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo-172 strain. It's a one-two punch: a new supply source and stronger IP protection.
Stock Action
ImmunityBio shares were down 1.13% at $7.88 at the time of publication on Monday. Over the past month, IBRX has gained about 2.9% versus a 4.2% rise in the S&P 500, and it's up roughly 290% year-to-date compared to the index's 7.7% gain.
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