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    DRUG:

    Anktiva (nogapendekin alfa inbakicept-pmln)

    i
    Other names: ALT-803, IL-15N72D:IL-15RαSu/Fc fusion protein complex, ALT 803, N-803, IL-15N72D:IL-15RαSu/IgG1 Fc complex
    Company:
    ImmunityBio
    Drug class:
    IL-15 superagonist
    Related drugs:
    8d
    Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, ImmunityBio, Inc.
    New P2 trial
    |
    Avastin (bevacizumab) • cisplatin • albumin-bound paclitaxel • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    8d
    Design and preliminary report of a randomized phase IIb clinical trial of multitargeted recombinant adenovirus 5 vaccines against CEA, MUC1, and brachyury (Tri-Ad5) and the IL-15 receptor superagonist nogapendekin alfa inbakicept in Lynch syndrome (TRIAD5-Plus): the first cross-network trial of the Cancer Prevention Clinical Trials Network (CP-CTNet). (PubMed, Front Immunol)
    In LS carriers without active cancer, the combination of Tri-Ad5 + NAI was well-tolerated; the RCT phase is ongoing. https://clinicaltrials.gov/study/, identifier NCT05419011.
    Clinical • P2b data • Journal
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    MUC1 (Mucin 1) • IL15 (Interleukin 15)
    |
    Anktiva (nogapendekin alfa inbakicept-pmln) • Tri-Ad5
    11d
    Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer (clinicaltrials.gov)
    P2, N=18, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Dec 2027 --> Jan 2026 | Trial primary completion date: Jan 2027 --> Dec 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    13d
    Decoding Immune Mechanisms in BCG-unresponsive Non-muscle Invasive Bladder Cancer. (PubMed, Front Biosci (Landmark Ed))
    In parallel, we highlight emerging intravesical immunotherapies for BCG-unresponsive NMIBC with carcinoma in situ, including nadofaragene firadenovec (Adstiladrin), nogapendekin alfa inbakicept-pmln (Anktiva), cretostimogene grenadenorepvec (CG0070), and detalimogene voraplasmid (EG-70). The lack of comparative data, coupled with the absence of predictive biomarkers of response, complicates treatment selection. Our review underscores that developing effective therapies for BCG-unresponsive disease will require combination strategies targeting multiple immune escape mechanisms that shape immune dynamics within the TME.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • HLA-E (Major Histocompatibility Complex, Class I, E) • KLRC1 (Killer Cell Lectin Like Receptor C1)
    |
    Adstiladrin (nadofaragene firadenovec-vncg) • Anktiva (nogapendekin alfa inbakicept-pmln) • cretostimogene grenadenorepvec (CG0070) • detalimogene voraplasmid (EG-70)
    21d
    FLINN: First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, Washington University School of Medicine | Trial completion date: Mar 2032 --> Jun 2032 | Initiation date: Mar 2026 --> Jun 2026 | Trial primary completion date: Mar 2032 --> Jun 2032
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Anktiva (nogapendekin alfa inbakicept-pmln)
    24d
    ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer (clinicaltrials.gov)
    P3, N=0, Withdrawn, ImmunityBio, Inc. | Not yet recruiting --> Withdrawn | N=688 --> 0
    Enrollment change • Trial withdrawal
    |
    Anktiva (nogapendekin alfa inbakicept-pmln)
    25d
    Lung-MAP Non-Match Sub-Study: Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) (clinicaltrials.gov)
    P2/3, N=82, Active, not recruiting, SWOG Cancer Research Network | Trial primary completion date: Feb 2027 --> Jun 2027
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • ALK fusion • ROS1 fusion • MET mutation • NTRK fusion
    |
    Keytruda (pembrolizumab) • gemcitabine • docetaxel • Cyramza (ramucirumab) • pemetrexed • Anktiva (nogapendekin alfa inbakicept-pmln) • Hemady (dexamethasone tablets)
    1m
    NAI for Sepsis With Persistent Lymphopenia (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, ImmunityBio, Inc.
    New P2 trial
    |
    Anktiva (nogapendekin alfa inbakicept-pmln)
    1m
    Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS) (clinicaltrials.gov)
    P2, N=0, Withdrawn, ImmunityBio, Inc. | N=20 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Anktiva (nogapendekin alfa inbakicept-pmln) • AgenT-797
    1m
    Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    Anktiva (nogapendekin alfa inbakicept-pmln)
    1m
    Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia (clinicaltrials.gov)
    P3, N=0, Withdrawn, ImmunityBio, Inc. | N=10 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Anktiva (nogapendekin alfa inbakicept-pmln) • AgenT-797
    1m
    Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer. (clinicaltrials.gov)
    P2, N=0, Withdrawn, ImmunityBio, Inc. | N=20 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Anktiva (nogapendekin alfa inbakicept-pmln) • m-ceNK cells