• Five issued U.S. patents cover the combination of ImmunityBio's IL-15 receptor agonist (NAI) with Bacillus Calmette-Guérin (BCG) for non-muscle invasive bladder cancer treatment, with terms extending through at least 2035
• Claims cover methods of treating non-muscle invasive bladder cancer (NMIBC) including BCG-naïve disease, defined-dose pharmaceutical compositions matching the approved NAI + BCG intravesical regimen, and two-vial commercial kits
• Portfolio reinforces ImmunityBio's IL-15 receptor agonist plus BCG position as the Company executes its exclusive U.S. Tokyo-172 BCG supply agreement with Japan BCG Laboratory and continues to develop Recombinant BCG (rBCG) to enhance USA supply

ImmunityBio, Inc. ((IBRX), a vertically integrated commercial-stage immunotherapy company, today announced that five United States patents have been issued to ImmunityBio covering the combination of its IL-15 receptor agonist ANKTIVA® (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for the treatment of cancer.

The five patents (U.S. Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432) with terms extending through at least 2035 include compositions of combinations of ANKTIVA and BCG. Together they protect the approved ANKTIVA plus BCG product, the specific intravesical dosing regimen, the two-vial commercial kit, and methods of treating non-muscle invasive bladder cancer (NMIBC) including BCG-naïve disease and bladder cancer.

The issued patent portfolio establishes composition-of-matter and method-of-use protection for ImmunityBio's IL-15 receptor agonist and BCG combination platform through the next decade and beyond. This intellectual property position supports the Company's commercial ANKTIVA plus BCG franchise in BCG-unresponsive NMIBC and bladder cancer, its pending supplemental BLA for BCG-unresponsive papillary-only disease, and the advancing QUILT-2.005 registrational trial evaluating ANKTIVA plus BCG versus BCG alone in BCG-naïve NMIBC carcinoma in situ.

The patent portfolio also intersects with ImmunityBio's recently announced exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo strain of BCG (Tokyo-172), which is supported by the positive Phase III SWOG S1602 results demonstrating non-inferiority of Tokyo-172 BCG versus TICE BCG on high-grade recurrence-free survival (HR 0.82; 95.8% CI 0.63–1.08) in 984 randomized patients with BCG-naïve high-grade NMIBC. As ImmunityBio engages with the FDA to pursue U.S. approval of Tokyo-172 BCG, the issued patent estate protects the combination of any approved BCG strain with the Company's IL-15 receptor agonist platform.