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    DRUG CLASS:

    IL-15 superagonist

    Related drugs:
    14d
    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
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    Avastin (bevacizumab) • cisplatin • albumin-bound paclitaxel • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    14d
    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)
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    Anktiva (nogapendekin alfa inbakicept-pmln) • Tri-Ad5
    17d
    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
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    PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive
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    Keytruda (pembrolizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    17d
    SOT201: cis-acting PD-1/IL-15 mutein-based immunocytokine under investigational study in solid tumors. (PubMed, Expert Opin Investig Drugs)
    This strategy has been shown to induce durable antitumor immunity and, in some cases, promote immune memory formation while limiting systemic toxicity. Ongoing clinical evaluation and rational combination approaches will ultimately define its therapeutic positioning in precision cancer immunotherapy.
    Journal
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL2 (Interleukin 2) • IL15 (Interleukin 15)
    27d
    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
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    PD-L1 (Programmed death ligand 1)
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • Anktiva (nogapendekin alfa inbakicept-pmln)
    1m
    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
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    Anktiva (nogapendekin alfa inbakicept-pmln)
    1m
    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)
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    BRAF mutation • ALK fusion • ROS1 fusion • MET mutation • NTRK fusion
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    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
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    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
    BGB-R046-101: A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors (clinicaltrials.gov)
    P1, N=42, Terminated, BeOne Medicines | N=75 --> 42 | Trial completion date: Dec 2027 --> Apr 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2027 --> Apr 2026; This decision is due to a company business decision with a strategy change on the BGB-R046 development in Advanced or Metastatic Solid Tumors.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • First-in-human
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    Tevimbra (tislelizumab-jsgr)