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

Phase 3 Trial Supports Regulatory Push

The randomized Phase 3 study enrolled nearly 1,000 eligible patients between 2017 and 2020. Patients received either TICE BCG, Tokyo-172 BCG, or intradermal priming followed by Tokyo-172 BCG.

At a median follow-up of 4.6 years, the study met its primary endpoint of high-grade recurrence-free survival. The Tokyo strain demonstrated a hazard ratio of 0.82 compared with TICE BCG, 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 Expands Patent Protection For ANKTIVA Plus BCG Franchise

Concurrently on Monday, ImmunityBio said it secured five U.S. patents tied to the use of its IL-15 receptor agonist ANKTIVA with Bacillus Calmette-Guérin (BCG) for cancer treatment, strengthening intellectual property protection for its bladder cancer franchise through at least 2035.

The company said the patents cover multiple aspects of the ANKTIVA plus BCG platform, including compositions, dosing regimens, treatment methods, and the commercial two-vial kit used in non-muscle invasive bladder cancer (NMIBC).

ImmunityBio also noted that the patent estate aligns with its recently announced exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo-172 strain of BCG.

IBRX Price Action: ImmunityBio shares were down 1.13% at $7.88 at the time of publication on Monday, according to Benzinga Pro.

Over the past month, IBRX has gained about 2.9% versus a 4.2% rise in the S&P 500 and is up roughly 290% year-to-date compared to the index’s 7.7% gain.

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