- Cross-trial analyses comparing ANKTIVA + BCG with nadofaragene firadenovec-vncg and TAR-200 provide important context, particularly in the absence of head-to-head data, highlighting its efficacy, durability, and safety in patients with CIS ± papillary disease and informing treatment selection and sequencing within current paradigms
- Exploration of intravesical recombinant BCG (rBCG) in BCG-naïve patients points to continued innovation and potential expansion into earlier lines of care
- Updates on company’s efforts to expand BCG access and on the status of randomized controlled BCG Naïve registrational trial
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced it will present new treatment comparison results evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus nadofaragene firadenovec-vncg and TAR-200 in patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease, at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18. An additional oral presentation will include new insights into research of intravesical recombinant BCG (rBCG) in BCG-naïve patients.
These analyses are clinically relevant for urologists managing an increasingly complex NMIBC treatment landscape, particularly among patients with BCG-unresponsive disease. In the context of limited direct comparative data, cross-trial analyses may provide important context to inform treatment selection and sequencing. By evaluating ANKTIVA + BCG relative to other available options, these data may help characterize comparative efficacy and durability of response within current treatment paradigms.
Dr. Soon-Shiong will be presenting on “The Role of IL15 in the Urological Setting” where he will discuss the mechanisms driving T cell and NK cell activation, examine current clinical evidence, and outline emerging combination approaches in bladder and prostate cancer.
“At AUA 2026, we are advancing the conversation around bladder cancer treatment with new comparative analyses that help contextualize the clinical value of ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS with or without papillary disease,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “These findings, along with emerging insights into recombinant BCG, reflect our commitment to expanding treatment options and addressing critical challenges such as BCG supply constraints. We also continue to prioritize research advancing next-generation immunotherapies for patients with urological cancers, including bladder and prostate cancers, and look forward to sharing this research at the upcoming AUA Annual Meeting.”
Oral Presentations
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The phase 1/2 ResQ133A-NMIBC trial: A study of intravesical recombinant Mycobacterium Bacillus Calmette Guérin (rBCG) in BCG naïve participants with non-muscle invasive bladder cancer
Meeks J. Oral Podium Presentation: Clinical Trials in Progress: Bladder Cancer, Sunday, May 17, 9:16 am – 9:24 am EDT, The Square, Learning Lab, Hall B, Walter E. Washington Convention Center
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Indirect Treatment Comparison of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and Nadofaragene Firadenovec-vncg in patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Edwards B. Oral Podium Presentation PD25-15. Session PD25: Bladder Cancer: Non-invasive V, Monday, May 18, 8:52 am - 9:00 am EDT, Room 206, Walter E. Washington Convention Center
Poster Presentation
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An Indirect Treatment Comparison (ITC) of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and TAR-200 in patients with BCG-unresponsive, Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Flanders S. Poster IP50-12. Session IP50: Bladder Cancer: Non-invasive IV, Sunday, May 17, 7:00 am – 9:00 am EDT, Room 146A, Walter E. Washington Convention Center
ImmunityBio Product Theater Presentation
Dr. Soon-Shiong will provide an update on the company’s efforts to expand BCG access and advance research in the BCG naïve setting, and will discuss the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer.
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The Role of IL15 in the Urological Setting
Dr. Patrick Soon-Shiong, ImmunityBio Product Theater, Saturday, May 16, 1:30 pm EDT, Product Theater booth 2701, Walter E. Washington Convention Center
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 receptor superagonist 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 dendritic cell membrane-bound IL-15 receptor alpha 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.
About ImmunityBio
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor superagonist, ANKTIVA® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy, safety, and durability of ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG; the interpretation of indirect treatment comparisons; the development of intravesical recombinant BCG; and the potential to address unmet needs in non-muscle invasive bladder cancer.
These statements are based on current expectations and are subject to risk and uncertainties that could cause actual results to differ materially, including risks related to the limitations of cross-trial comparisons; clinical development and regulatory approval; the timing and results of clinical trials; the ability to demonstrate safety and efficacy; regulatory decisions; manufacturing and supply constraints, including BCG availability; competition; and market acceptance.
More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov.
ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.
Contacts
ImmunityBio Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com
