ImmunityBio Secures U.S. Patent Protection Through 2035 for ANKTIVA-BCG Combination Cancer Therapy
ImmunityBio has announced the issuance of five United States patents covering the combination of its IL-15 receptor agonist ANKTIVA with Bacillus Calmette-Guérin for the treatment of cancer, significantly strengthening the company’s intellectual property position in bladder cancer immunotherapy and extending commercial protection for its flagship therapeutic platform through at least 2035.
The newly issued patents represent an important milestone for ImmunityBio as the company continues expanding its commercial and clinical presence in non-muscle invasive bladder cancer (NMIBC), a disease area where treatment limitations and BCG supply challenges have created substantial unmet medical need. The patent portfolio covers multiple aspects of the ANKTIVA plus BCG platform, including compositions of matter, treatment methods, dosing regimens, and the company’s commercial two-vial administration kit.
The five patents—U.S. Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432—collectively establish broad intellectual property protection surrounding the company’s IL-15 receptor agonist technology when used in combination with BCG. According to ImmunityBio, the patents directly protect the currently approved ANKTIVA plus BCG product as well as future clinical and commercial applications involving bladder cancer treatment.
The announcement further solidifies ImmunityBio’s efforts to establish ANKTIVA plus BCG as a foundational immunotherapy platform for bladder cancer patients, particularly those with BCG-unresponsive disease. The company is also pursuing expanded indications through ongoing regulatory submissions and late-stage clinical trials.
Non-muscle invasive bladder cancer remains one of the most common forms of bladder cancer, accounting for the majority of newly diagnosed cases. Standard treatment often involves transurethral surgical resection followed by intravesical therapy using BCG, a live attenuated bacterial immunotherapy that has served as the standard of care for decades. However, many patients eventually become unresponsive to BCG therapy, leaving limited bladder-preserving treatment options aside from radical cystectomy, a major surgical procedure involving bladder removal.
ImmunityBio’s ANKTIVA platform was developed to enhance immune activation within the tumor microenvironment by leveraging the biology of interleukin-15, or IL-15, a cytokine involved in stimulating natural killer cells and CD8-positive T cells. Unlike some immunotherapies that may also expand suppressive regulatory T cells, IL-15 signaling is designed to activate anti-tumor immune responses while potentially avoiding certain immunosuppressive effects.
ANKTIVA combines an IL-15 superagonist complex with an IL-15 receptor alpha fusion protein to enhance immune system activation. When administered alongside BCG, the therapy is intended to amplify the body’s immune response against bladder cancer cells.
The new patent estate provides extensive coverage across several critical commercial and scientific dimensions. The protections include not only the underlying molecular compositions but also the specific methods of administering the therapy, intravesical dosing strategies, and the commercial packaging configuration physicians use in clinical practice.
According to ImmunityBio founder and Executive Chairman Patrick Soon-Shiong, the company has spent more than a decade building an integrated immunotherapy platform centered on IL-15 biology and its ability to activate multiple immune cell populations critical for anti-cancer activity.
Soon-Shiong stated that the patents protect the ANKTIVA plus BCG platform across all commercially important layers, including the composition of matter, treatment methods, wild-type and mutant IL-15 combinations, dosing regimens, and the two-vial product configuration used in medical practice.
He emphasized that the IL-15 and BCG combination serves as the backbone of ImmunityBio’s bladder cancer franchise and noted that the patent protections extend through at least 2035. He also highlighted that the company has separately secured patents covering combinations of ANKTIVA with checkpoint inhibitors, potentially broadening future immunotherapy applications beyond bladder cancer.
The company’s leadership views the patent portfolio as especially important given its broader commercial and regulatory expansion efforts. ImmunityBio currently markets ANKTIVA plus BCG for BCG-unresponsive NMIBC and is pursuing additional regulatory approvals, including a supplemental Biologics License Application for BCG-unresponsive papillary-only disease.
At the same time, the company continues advancing its QUILT-2.005 registrational study evaluating ANKTIVA plus BCG compared with BCG alone in patients with BCG-naïve carcinoma in situ NMIBC. This trial may help expand the therapy’s role earlier in the bladder cancer treatment continuum if successful.
ImmunityBio President and Chief Executive Officer Richard Adcock stated that the patent estate provides long-term protection for one of the company’s most important commercial franchises during a period of substantial growth and expansion.
According to Adcock, the company is simultaneously broadening the clinical utility of ANKTIVA plus BCG, strengthening its BCG supply chain, and generating significant revenue growth. He noted that the combination of durable patent protection, validated clinical data, and diversified manufacturing supply could help position ANKTIVA plus BCG as a long-term standard of care in bladder cancer treatment.
The patent announcement also intersects with another major strategic initiative recently announced by ImmunityBio involving a supply agreement with Japan BCG Laboratory. The exclusive U.S. development and supply agreement centers on the Tokyo-172 strain of BCG, which could potentially serve as an additional BCG source for the U.S. market.
BCG supply shortages have been a longstanding challenge in bladder cancer treatment, creating treatment delays and limiting access for patients worldwide. By securing additional supply partnerships, ImmunityBio aims to improve long-term manufacturing stability and commercial scalability for its bladder cancer franchise.
The Tokyo-172 BCG strain has also been supported by clinical data from the Phase III SWOG S1602 trial. That study demonstrated non-inferiority of Tokyo-172 compared with TICE BCG in patients with high-grade BCG-naïve NMIBC. The trial enrolled 984 randomized patients and showed favorable recurrence-free survival outcomes.
ImmunityBio is currently engaging with the FDA regarding potential U.S. approval of Tokyo-172 BCG. Importantly, the company noted that its patent estate protects the combination of ANKTIVA with any approved BCG strain, including future commercial applications involving Tokyo-172.
The individual patents issued to ImmunityBio each address distinct aspects of the ANKTIVA plus BCG platform strategy.
U.S. Patent No. 11,173,191, issued in November 2021, covers the foundational method of treating cancer through administration of BCG together with the IL-15N72D:IL-15 receptor alpha complex known as ALT-803 or ANKTIVA. The patent includes claims specifically directed toward bladder cancer, NMIBC, BCG-naïve disease, and intravesical delivery. According to the company, this patent directly aligns with the FDA-approved use of ANKTIVA plus BCG.
U.S. Patent No. 11,679,144, issued in June 2023, expands protection to pharmaceutical compositions combining BCG with a wild-type IL-15 receptor complex. The patent also covers the commercial two-vial kit format consisting of separate BCG and IL-15 components packaged together with instructions for use in cancer treatment.
U.S. Patent No. 11,890,323, issued in February 2024, focuses specifically on methods of treating NMIBC, including BCG-naïve disease, using intravesical administration of BCG plus a wild-type IL-15 receptor complex. ImmunityBio noted that this patent complements earlier protection by covering both mutant and wild-type IL-15 formulations, reducing opportunities for competitive design-around strategies.
U.S. Patent No. 12,268,731, issued in April 2025, protects the defined-dose composition itself, including the specific intravesical dosing regimen utilized in the FDA-approved ANKTIVA labeling and in the company’s QUILT clinical studies. The patent also extends to the associated two-vial treatment kit configuration.
Finally, U.S. Patent No. 12,318,432, issued in June 2025, specifically protects the commercial two-vial kit supplied to physicians. The patent covers the packaging arrangement involving one vial containing BCG and a second vial containing ANKTIVA’s dimeric IL-15 receptor alpha fusion complex with IL-15N72D molecules, along with treatment instructions for neoplastic diseases.
The breadth of the intellectual property portfolio highlights ImmunityBio’s broader strategy of building layered protection around both its core immunotherapy platform and its commercial delivery infrastructure. By securing patents covering molecular compositions, treatment methods, dosing regimens, and packaging formats, the company aims to establish long-term barriers to competitive entry while supporting future lifecycle expansion opportunities.
The announcement comes during a period of increasing interest in cytokine-based immunotherapies and combination immune-oncology approaches. While checkpoint inhibitors have transformed cancer treatment over the past decade, researchers continue seeking complementary immunomodulatory strategies capable of enhancing anti-tumor immune activation and improving durable clinical responses.
IL-15-based therapies have attracted particular attention because of their ability to stimulate natural killer cells and cytotoxic T cells, two immune populations critical for tumor elimination. ImmunityBio believes the combination of IL-15 agonism with intravesical BCG immunotherapy may offer a differentiated approach capable of producing durable immune responses in bladder cancer patients.
As the company continues pursuing additional regulatory approvals, expanding clinical trials, and strengthening manufacturing partnerships, the newly issued patents provide an important foundation supporting the long-term commercial future of ANKTIVA plus BCG across multiple bladder cancer treatment settings.
About ANKTIVA ® (nogapendekin alfa inbakicept-pmln)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.
ANKTIVA® is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
