Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio - LARVOL DELTA

ImmunityBio Confirms Statistical Power in Pivotal Randomized BCG-Naïve NMIBC Trial to Detect Clinically Meaningful Differences Between ANKTIVA Plus BCG Versus BCG Alone; Supplemental BLA Submission on Track for 2026 (Businesswire) - "The QUILT-2.005 randomized clinical trial is on track for final analysis and supplemental Biologics License Application (BLA) submission in 2026 for the BCG-naïve NMIBC carcinoma in situ with or without papillary indication with no additional enrollment required; The Independent Data Monitoring Committee (IDMC) confirmed that the fully enrolled study (N=366) is adequately powered to detect the pre-specified difference in complete response rate between the experimental and control arms, and that no additional enrollment is required; A planned interim analysis was conducted by the IDMC per the protocol once 50% of enrolled patients (N=183) in Cohort A were evaluable for the primary efficacy endpoint...Supplemental BLA submission is anticipated Q4 2026."

DSMB • sBLA • Bladder Cancer

Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ImmunityBio, Inc.

New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock

Prolonged Progression-Free Survival, Disease-Free Survival and Cystectomy Avoidance with IL-15 Receptor Lymphocyte-Stimulating Agent NAI plus BCG in BCG-Unresponsive Papillary-Only NMIBC. (PubMed, J Urol) - P2/3 | "In QUILT-3.032, the efficacy of IL-15 receptor agonist, nogapendekin alfa inbakicept (NAI) in combination with BCG for BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC) was assessed...Most TRAEs were grade 1-2 (61%) with 3% grade 3, and no grade 4-5. The 12- and 36-month DFS, PFS, DSS, and cystectomy avoidance rates demonstrate the effectiveness and safety of NAI plus BCG in the management of BCG-unresponsive papillary disease."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IL15

ResQ108B-PANC: Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: ImmunityBio, Inc.

New P1 trial • Oncology • Pancreatic Cancer • Solid Tumor

A novel anti-PD-1/IL-15 fusion protein JMT108 (SYS6090) with highly selective PD-1⁺ immune cell activation and potent anti-tumor efficacy (AACR 2026) - P1/2 | "JMT108 showed markedly higher selectivity for PD-1⁺ T cell activation versus N-803, with >10,000 fold lower potency in naïve PBMCs. Notably, it reduced PD-1 expression on activated CD8⁺ T cells, in contrast to the upregulation observed with N-803. In hHSC-mice, JMT108 induced sustained expansion of CD8⁺ effector cells (PD-1⁺) without proliferation of naïve T cells."

Clinical • Immune cell • IO biomarker • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor • CD8 • IL15

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). (AUA 2026) - No abstract available

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors (ImmunityBio Press Release) - "The authorization was granted following a review that considered prior regulatory decisions by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in accordance with applicable local requirements....This approval in Macau represents the first authorization for ANKTIVA in Asia. The Company continues to engage with additional health authorities across the region as part of its international regulatory strategy."

Approval • Bladder Cancer

Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ImmunityBio, Inc.

New P2 trial • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

FL115, a novel IL-15 superagonist rationally designed to minimize safety risks for cancer immunotherapy (AACR 2026) - "Our study revealed the mechanism underlying the superior safety of FL115 over ALT803 while exhibiting comparable anti-tumor activities. These findings highlight the rational design strategy of FL115 as next-generation IL-15-based superagonist, supporting its favorable safety and preliminary clinical responses observed in multiple Phase 1 clinical studies."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IL15 • IL6

γc-cytokines in HIV Cure Research. (PubMed, Curr Opin HIV AIDS) - "Collectively, γc-cytokines show promise as dual-function agents capable of targeting latent HIV reservoirs through latency reversal and immune enhancement. Emerging preclinical and clinical data support their integration into multipronged strategies aimed at reservoir reduction and sustained immune-mediated control of HIV, laying groundwork for the development of durable functional cure approaches."

Journal • Human Immunodeficiency Virus • Infectious Disease • IL15 • IL2

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). (AUA 2026) - No abstract available

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Vadim S Koshkin | N=18 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: ImmunityBio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase II Trial of Neoadjuvant (NA) Pembrolizumab + N-803 alone or in combination with PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma (HNSCC) (MHNCS 2026) - P2 | "TBD"

Clinical • Combination therapy • IO biomarker • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL15 • IL2 • PD-L1

Peripheral immune dynamics and biomarkers of clinical response in patients with castration-resistant prostate cancer treated with combination immunotherapy* (AACR-IO 2026) - P1/2 | "The phase I/II Quick Efficacy Seeking Trial (QuEST1, NCT03493945) evaluating the potential of combination immunotherapy in CRPC was designed to generate a tumor-directed immune response with BNVax (a vaccine targeting brachyury, a transcription factor linked to invasion/metastasis) and facilitate the resulting anti-tumor activity with ICB (with bintrafusp alfa (BA), a bifunctional dual inhibitor of PD-L1 and TGF-β) and a lymphocyte stimulating immunocytokine (the IL-15 receptor superagonist nogapendekin alfa inbakicept-pmln (NAI), also known as N-803). These findings indicate that the addition of NAI to tumor-targeted vaccine and ICB results in increased clinical activity, enhanced ALC levels, and immune activation of both NK and T cells. These observations warrant further investigation of easily accessible peripheral biomarkers, including ALC, in patients with CRPC and suggest that evaluation of an array of circulating biomarkers may be beneficial in predicting..."

Biomarker • Clinical • IO biomarker • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD8 • IFNG • IL15 • TGFB1

QUILT-3.076 Safety Phase I Trial of M-ceNK Cells (Businesswire) - "Patient infusions to date: N=10. All infusion performed in an outpatient setting; Cancer types (2^nd line & greater): Breast (N=4), Colon (N=1), Duodenum (N=1), Renal (N=1), Pancreatic (N=1), Rectal (N=1), Osteosarcoma (N=1); Range of M-ceNK infusions (2 to 5 bags infused) with NAI subcutaneously; Safety: Zero (0%) TRAE Grade 4 or 5. Zero (0%) cytokine storm."

P1 data • Breast Cancer • Colon Cancer • Osteosarcoma • Pancreatic Cancer • Rectal Cancer • Renal Cell Carcinoma

Characterization of the anti-tumor efficacy of memory cytokine enriched NK cells against tumors with neuroendocrine features (AACR-IO 2026) - "M-ceNK are derived from an apheresis product (from healthy donors or cancer patients) and exposed to a cocktail of cytokines including N-803, IL-12, and IL-18 until a highly purified CD3 NEG CD56 HIGH cell population results. In: Proceedings of the AACR Immuno-Oncology Conference (AACR IO): Discovery and Innovation in Cancer Immunology: Revolutionizing Treatment through Immunotherapy; 2026 Feb 18-21; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Immunol Res 2026;14(2 Suppl):Abstract nr A018."

Clinical • IO biomarker • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Neoplasm • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • GZMB • IFNG • IL12A • IL15 • IL18 • KLRG1 • NCAM1 • TIGIT

005IC - Bladder Cancer in the Office from Indolent to Aggressive: A Practical Guideline-based Approach (AUA 2026) - "With the proliferation of options (e.g. Adstiladrin, Anktiva, gemcitabine/docetaxel, pembrolizumab), it is critical to understand 1) indications for these agents, 2) timing and sequencing of administration, and 3) management of common side effects...New systemic therapies have emerged (e.g. enfortumab vedotin, pembrolizumab, erdafitinib) and urology providers need to be aware of the changing landscape of advanced disease...Learning Objective 7: Identify patients that are candidates for new systemic therapies for advanced bladder cancer, including the FDA-approved indications. Learning Objective 8: Identify the common side effects and management strategies of new systemic therapies for advanced bladder cancer."

Bladder Cancer • Genito-urinary Cancer • Oncology • Palliative care • Solid Tumor • Urology

Phase III trial ResQ201A of NAI plus tislelizumab and docetaxel vs. docetaxel monotherapy for advanced or metastatic NSCLC resistant to ICI therapy (ELCC 2026) - P3 | "Prior phase II studies have demonstrated the potential for IL-15 superagonist nogapendekin alfa inbakicept (NAI), that proliferates and activates NK and T cells, to enhance ICI efficacy, prolonging overall survival (OS) when used in combination with an ICI. Exploratory samples are being collected for analysis. ResQ201A is a global trial and participants have been enrolled."

Metastases • Monotherapy • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK

IL 15 enhances preclinical efficacy of anti-core 1 O-glycans monoclonal antibody NEO-201 against human endometrial and ovarian cancer. (PubMed, Front Immunol) - "A previous study showed that IL-15 superagonist complex (N-803) enhanced ADCC activity mediated by NEO-201 in vitro against several human carcinoma cells, by modulating NK cells activation and cytotoxicity. In this study we demonstrated that IL-15 enhanced ADCC mediated by NEO-201 in vitro against human endometrial and ovarian cancer cell lines expressing NEO-201 target antigen, and that the combination of IL-15 and NEO-201, using purified human NK cells as effectors, had a modest effect in prolonging the survival of mice bearing human ovarian cancer, compared to IL-15 or NEO-201 alone. The ability of IL-15 to enhance NEO-201 efficacy, with NK cells as effectors, supports the hypothesis of combining NEO-201 and IL-15 with NK cell therapy (i.e. IL-15-secreting CAR-NK cells with a longer IL-15 in vivo half-life and stronger NK activity) for the treatment of gynecological cancers expressing O-glycans recognized by NEO-201."

Journal • Preclinical • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • IL15

Advances in Intravesical Therapy for Non-Muscle-Invasive Bladder Cancer. (PubMed, Crit Rev Oncol Hematol) - "Intermediate-risk patients could benefit from either intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) instillation, with emerging therapies such as UGN-102 chemoablation showing promise...Moreover, alternative agents such as sequential gemcitabine and docetaxel instillation have demonstrated favorable outcomes in both BCG-naïve and BCG-unresponsive patients...Gene therapy (nadofaragene firadenovec), oncolytic viral therapy (CG0070), interleukin-15 superagonist (Nogapendekin alfa-inbakicept), and innovative drug delivery systems (TAR-200) have shown encouraging clinical potential in this population. This review provides an overview of current intravesical treatment strategies for NMIBC across different risk groups and highlights promising new approaches aimed at overcoming the limitations of BCG therapy."

Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • IL15

ImmunityBio Announces NCCN Clinical Practice Guidelines in Oncology Have Been Updated to Include ANKTIVA Plus BCG for Patients With BCG-Unresponsive NMIBC With Papillary-Only Disease (Businesswire) - "This update expands previous NCCN clinical guideline recommendations, which included patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary disease, to now also recognize patients with BCG-unresponsive NMIBC with papillary-only disease as candidates for treatment with ANKTIVA plus BCG. Both recommendations are Category 2A."

NCCN guideline • Bladder Cancer

Novel Interleukin-15 Superagonist (n-803) and Invariant Natural Killer T Cell (agent-797) Combination Immunotherapy for Unresolving Coccidioides Immitis Infection (ATS 2026) - No abstract available

Infectious Disease • IL15

A COST-CONSEQUENCE ANALYSIS OF NOGAPENDEKIN ALFA INBAKICEPT-PMLN (NAI) IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN (BCG) VERSUS TAR-200 FOR BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU±PAPILLARY DISEASE (NMIBC CIS) (ISPOR 2026) - "These results demonstrate that NAI+BCG offers an improvement in complete response rates for BCG‑unresponsive NMIBC CIS patients, with a lower cost per sustained responder outcome within a Medicare population."

Combination therapy • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy. (PubMed, J Med Econ) - "Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data. Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1."

HEOR • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor