ImmunityBio secures five US patents for ANKTIVA plus BCG bladder cancer therapy through 2035

Edited by Robert McTiernan··3 min read

ImmunityBio (Nasdaq: IBRX), headquartered in Culver City, California, has received five issued US patents covering the combination of its IL-15 receptor agonist ANKTIVA BCG bladder cancer regimen, with terms extending through at least 2035. The patents collectively protect composition-of-matter, method-of-use, dosing regimen, and commercial kit configurations for the approved ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG intravesical therapy in non-muscle invasive bladder cancer treatment.

The five patents — US Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432 — span issuance dates from November 2021 through June 2025. Together they establish layered exclusivity across the approved BCG-unresponsive NMIBC indication, the pending supplemental BLA for BCG-unresponsive papillary-only disease, and the QUILT-2.005 registrational trial evaluating ANKTIVA plus BCG versus BCG alone in BCG-naïve NMIBC carcinoma in situ.

The foundational method-of-treatment patent, No. 11,173,191, covers administration of BCG with the IL-15N72D:IL-15RαSu/Fc complex with dependent claims specific to bladder cancer, NMIBC, BCG-naïve NMIBC, and intravesical administration. Subsequent patents extend protection to wild-type IL-15:IL-15RαSu combinations, closing a design-around route that would have existed had only the IL-15N72D mutant form been covered. Patent No. 12,268,731 covers the defined-dose composition matching the approved label and trial regimens, while No. 12,318,432 covers the two-vial commercial kit as supplied to physicians. The portfolio’s breadth across both mutant and wild-type IL-15 forms, specific dose configurations, and kit presentation represents a deliberate effort to foreclose incremental workarounds rather than rely on a single claim set.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex consisting of an IL-15N72D mutant fused with IL-15 receptor alpha sushi domain, designed to activate NK cells and CD8+ T cells while avoiding expansion of suppressive regulatory T cells. Delivered intravesically in combination with BCG, the mechanism is intended to reinforce the innate immune response that BCG elicits in the bladder mucosa, sustaining NK and memory T cell activity against tumor clones that escape T cell surveillance. ANKTIVA received US FDA approval in April 2024 for BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors, the first new approval in this setting in over two decades.

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The ImmunityBio patents also intersect with the company’s recently announced exclusive US Development and Supply Agreement with Japan BCG Laboratory for the Tokyo-172 BCG strain. Phase III SWOG S1602 data in 984 randomized patients with BCG-naïve high-grade NMIBC demonstrated non-inferiority of Tokyo-172 versus TICE BCG on high-grade recurrence-free survival, with a hazard ratio of 0.82 (95.8% CI 0.63–1.08). ImmunityBio is engaging with the US FDA to pursue US approval of Tokyo-172, and the issued patent estate is structured to cover the combination of any approved BCG strain with the IL-15 receptor agonist platform, not solely the TICE strain used in the approved product.

ImmunityBio’s pending supplemental BLA for BCG-unresponsive papillary-only disease and the ongoing QUILT-2.005 trial in BCG-naïve NMIBC represent the two most commercially material near-term catalysts. If approved, the papillary-only supplemental BLA would expand the addressable population beyond the current CIS-inclusive label. QUILT-2.005, evaluating ANKTIVA plus BCG versus BCG alone in the BCG-naïve setting, targets a substantially larger patient population than the approved BCG-unresponsive indication. The issued patent portfolio covers both settings, meaning exclusivity through at least 2035 would apply to any label expansions achieved within that clinical program. Specific clinical results from QUILT-2.005 remain undisclosed pending trial completion.

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