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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:
3d
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov)
P1/2, N=53, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
Trial completion
|
TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
|
TMB-H • MSI-H/dMMR
|
bintrafusp alfa (M7824) • epacadostat (INCB024360) • Anktiva (nogapendekin alfa inbakicept-pmln)
7d
Engineered VNP20009 expressing IL-15&15Rα augments anti-tumor immunity for bladder cancer treatment. (PubMed, Biomaterials)
In a recent clinical trial, a new super-agonist complex of IL-15 - N803, has shown promising results when used in combination with BCG to treat patients with bladder cancer who do not respond to BCG. Moreover, the sequential intravesical instillation of epirubicin (EPI), a first-line bladder cancer drug, followed by thermally activated 15&15Rα@VNP, could achieve further improved therapeutic responses, without causing significant side effects. Therefore, this study shows that 15&15Rα@VNP can be effectively used in the treatment of bladder cancer and can be used as a complementary therapy to chemotherapy agents, promising for potential clinical translation in bladder cancer treatment.
Journal
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IL15 (Interleukin 15)
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epirubicin • Anktiva (nogapendekin alfa inbakicept-pmln)
1m
3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov)
P1, N=28, Active, not recruiting, Rockefeller University | Recruiting --> Active, not recruiting
Enrollment closed
|
CD4 (CD4 Molecule)
|
Anktiva (nogapendekin alfa inbakicept-pmln)
1m
QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=50, Recruiting, ImmunityBio, Inc. | Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
Trial completion date • Trial primary completion date • Metastases
|
CD4 (CD4 Molecule) • NKG2D (killer cell lectin like receptor K1)
|
Anktiva (nogapendekin alfa inbakicept-pmln) • m-ceNK cells
1m
QUILT-88: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
P2, N=328, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Metastases
|
gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
2ms
Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate. (PubMed, Oncologist)
The epidermal growth factor receptor-targeted antibody-nanocell conjugate E-EDV-D682 provides tumor-targeted chemotherapy in the form of its anthracycline metabolite PNU159682 (nemorubicin) cargo and is currently being studied in combination with immunomodulatory EDVs delivering the adjuvant α-galactosyl ceramide (GC)...Under the initial single-patient Investigational New Drug (spIND) protocol, the patient received N-803, PD-L1 t-haNK cells, and the albumin doxorubicin conjugate aldoxorubicin for ~27 months...Due to progression, a second spIND protocol was designed whereby the patient received E-EDV-D682 plus EDV-GC for more than 24 months, which resulted in stable disease and the patient's continued survival at the time this report was written. The patient's extended survival despite the dire prognosis associated with recurrent mPC points to the merits of this temporal combination regimen in overcoming immuno-chemo resistance with enhanced immune activity required for tumor response and extended survival.
Journal
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL15 (Interleukin 15)
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Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
2ms
QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P1, N=19, Terminated, Altor BioScience | Phase classification: P1/2 --> P1 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Phase classification • Trial termination
|
Anktiva (nogapendekin alfa inbakicept-pmln)
2ms
Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis (clinicaltrials.gov)
P1, N=10, Completed, ImmunityBio, Inc. | Recruiting --> Completed | Trial completion date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2024 --> Sep 2024
Trial completion • Trial completion date • Trial primary completion date
|
NCAM1 (Neural cell adhesion molecule 1)
|
Anktiva (nogapendekin alfa inbakicept-pmln)
2ms
Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
P2, N=32, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Aug 2024
Trial completion • Trial completion date • Metastases
|
CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
|
bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
2ms
CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov)
P1, N=11, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | N=25 --> 11
Enrollment closed • Enrollment change • Combination therapy • Metastases • Immune cell
|
Erbitux (cetuximab) • Yervoy (ipilimumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • CIML NK
3ms
Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19 (clinicaltrials.gov)
P1, N=1, Terminated, ImmunityBio, Inc. | Phase classification: P1b --> P1 | Active, not recruiting --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Phase classification • Trial termination • Immunomodulating
|
Anktiva (nogapendekin alfa inbakicept-pmln)
3ms
QUILT-3.080: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov)
P1/2, N=3, Terminated, ImmunityBio, Inc. | Phase classification: P1b/2 --> P1/2 | N=173 --> 3 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Phase classification • Enrollment change • Trial termination
|
Avastin (bevacizumab) • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • oxaliplatin • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-021 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
3ms
Trial primary completion date • Metastases
|
gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
3ms
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors (clinicaltrials.gov)
P2, N=147, Active, not recruiting, ImmunityBio, Inc. | Phase classification: P2b --> P2 | Trial completion date: Dec 2024 --> Dec 2030 | Trial primary completion date: May 2024 --> Aug 2029
Phase classification • Trial completion date • Trial primary completion date • Checkpoint inhibition
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
3ms
Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov)
P2, N=186, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2027 --> Feb 2027
Trial completion date
|
MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • EPCAM (Epithelial cell adhesion molecule)
|
Anktiva (nogapendekin alfa inbakicept-pmln) • Tri-Ad5
3ms
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. (clinicaltrials.gov)
P1/2, N=9, Terminated, ImmunityBio, Inc. | N=79 --> 9 | Trial completion date: Oct 2023 --> Jan 2024 | Active, not recruiting --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial completion date • Trial termination
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
Avastin (bevacizumab) • cisplatin • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
4ms
QUILT-3.040t: QUILT-3.040: ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer (clinicaltrials.gov)
P1/2, N=3, Terminated, NantCell, Inc. | Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; The study was terminated before any dose escalation occurred in order to pursue other studies designed to more extensively evaluate the combination of ETBX-011 and N-803 along with other immunotherapy agents.
Phase classification • Trial termination • Combination therapy
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Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011
4ms
QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov)
P1/2, N=4, Terminated, ImmunityBio, Inc. | N=65 --> 4 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial termination
|
Avastin (bevacizumab) • Erbitux (cetuximab) • cisplatin • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Portrazza (necitumumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-021 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
4ms
Memory-like Natural Killer (NK) Cell Therapy With N-803 in Patients With Renal Cell Carcinoma or Urothelial Carcinoma (clinicaltrials.gov)
P1, N=5, Not yet recruiting, Dana-Farber Cancer Institute | Initiation date: Jun 2024 --> Sep 2024 | Trial primary completion date: Feb 2025 --> Dec 2025
Trial initiation date • Trial primary completion date • Combination therapy
|
Anktiva (nogapendekin alfa inbakicept-pmln) • CIML NK
4ms
Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov)
P2, N=186, Recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2027 --> Jul 2027
Trial completion date
|
MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • EPCAM (Epithelial cell adhesion molecule)
|
Anktiva (nogapendekin alfa inbakicept-pmln) • Tri-Ad5
4ms
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (clinicaltrials.gov)
P2, N=20, Recruiting, ImmunityBio, Inc. | Not yet recruiting --> Recruiting
Enrollment open
|
IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha)
|
Avastin (bevacizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
5ms
Nogapendekin alfa Inbakicept: First Approval. (PubMed, Drugs)
In April 2024, nogapendekin alfa inbakicept was approved for use with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours in the USA. This article summarizes the milestones in the development of nogapendekin alfa inbakicept leading to this first approval for the treatment of cancer.
Review • Journal
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IL15 (Interleukin 15)
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Anktiva (nogapendekin alfa inbakicept-pmln)
5ms
Trial suspension
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PD-L1 (Programmed death ligand 1)
|
Anktiva (nogapendekin alfa inbakicept-pmln) • H1299 lung cancer cell lysate vaccine with Montanide ISA-51 VG adjuvant
5ms
Enrollment open • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Anktiva (nogapendekin alfa inbakicept-pmln)
5ms
Efficiently targeting neuroblastoma with the combination of anti-ROR1 CAR NK cells and N-803 in vitro and in vivo in NB xenografts. (PubMed, Mol Ther Oncol)
In vivo, anti-ROR1 CAR exPBNK plus N-803 significantly (p < 0.05) enhanced survival in human ROR1+ NB xenografted NSG mice compared to anti-ROR1 CAR exPBNK alone. Our results provide the rationale for further development of anti-ROR1 CAR exPBNK cells plus N-803 as a novel combination immunotherapeutic for patients with recurrent and/or refractory ROR1+ NB.
Preclinical • Journal
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ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
|
Anktiva (nogapendekin alfa inbakicept-pmln)
5ms
CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov)
P1, N=25, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Sep 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases • Immune cell
|
Erbitux (cetuximab) • Yervoy (ipilimumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • CIML NK
5ms
Phase classification • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
cyclophosphamide • Trodelvy (sacituzumab govitecan-hziy) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
5ms
QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (clinicaltrials.gov)
P1/2, N=3, Terminated, ImmunityBio, Inc. | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Trial termination
|
Avastin (bevacizumab) • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • oxaliplatin • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • GI-4000 • Neukoplast (CST-101)
6ms
Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=20, Recruiting, ImmunityBio, Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
Rituxan (rituximab) • cyclophosphamide • fludarabine IV • Anktiva (nogapendekin alfa inbakicept-pmln) • CD19.t-haNK
6ms
QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (clinicaltrials.gov)
P1/2, N=4, Terminated, ImmunityBio, Inc. | N=173 --> 4 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial termination
|
Avastin (bevacizumab) • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • oxaliplatin • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • GI-4000 • NK92-CD16-158V • aldoxorubicin (INNO-206)
6ms
Trial suspension
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
Enrollment open • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
RV582: Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission (clinicaltrials.gov)
P1, N=0, Withdrawn, Henry M. Jackson Foundation for the Advancement of Military Medicine | N=35 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal
|
CD4 (CD4 Molecule)
|
Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC) (clinicaltrials.gov)
P2, N=7, Terminated, ImmunityBio, Inc. | N=24 --> 7 | Unknown status --> Terminated
Enrollment change • Trial termination • Combination therapy • Metastases
|
Anktiva (nogapendekin alfa inbakicept-pmln) • Neukoplast (CST-101)
7ms
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov)
P1/2, N=53, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=113 --> 53
Enrollment closed • Enrollment change
|
TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
|
TMB-H • MSI-H/dMMR
|
bintrafusp alfa (M7824) • epacadostat (INCB024360) • Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
QUILT-2.005: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov)
P1/2, N=596, Recruiting, ImmunityBio, Inc. | Trial completion date: Dec 2027 --> Dec 2038 | Trial primary completion date: Dec 2025 --> Dec 2028
Trial completion date • Trial primary completion date • Combination therapy
|
Anktiva (nogapendekin alfa inbakicept-pmln)
8ms
Enrollment closed • Combination therapy
|
Anktiva (nogapendekin alfa inbakicept-pmln)
8ms
Enrollment change
|
CD4 (CD4 Molecule)
|
Anktiva (nogapendekin alfa inbakicept-pmln)
8ms
N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=28 --> 0 | Trial completion date: Aug 2026 --> Apr 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2024 --> Apr 2024
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy
|
CD4 (CD4 Molecule)
|
bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln)
8ms
New P1 trial • Combination therapy
|
Anktiva (nogapendekin alfa inbakicept-pmln) • CIML NK
8ms
Enrollment open • Metastases
|
Zynyz (retifanlimab-dlwr) • SX-682 • Anktiva (nogapendekin alfa inbakicept-pmln)
8ms
New P1 trial • Combination therapy
|
Anktiva (nogapendekin alfa inbakicept-pmln) • CIML NK