^
Contact us  to learn more about
our Premium Content:  News alerts, weekly reports and conference planners
DRUG:

Anktiva (nogapendekin alfa inbakicept-pmln)

i
Company:
ImmunityBio
Drug class:
IL-15 superagonist
Related drugs:
8d
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=55, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Jan 2025 --> Jan 2027
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
16d
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 --> Jan 2028 | Trial primary completion date: Feb 2027 --> Jul 2027
Trial completion date • Trial primary 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
22d
QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma. (clinicaltrials.gov)
P1/2, N=0, Withdrawn, ImmunityBio, Inc. | Phase classification: P1b/2 --> P1/2
Phase classification
|
Erbitux (cetuximab) • Bavencio (avelumab) • cyclophosphamide • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-051 • ETBX-061 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
25d
New P2 trial
|
gemcitabine • Anktiva (nogapendekin alfa inbakicept-pmln)
26d
IL-15 transpresentation by ovarian cancer cells improves CD34+ progenitor-derived NK cell's anti-tumor functionality. (PubMed, Oncoimmunology)
However, others have substantiated that systemic administration of ALT/N-803, a soluble molecule mimicking transIL-15, leads to T cell-mediated rejection of the infused allogeneic NK cell product...Superior killing and granzyme B secretion were also observed in transIL-15 OC spheroids. Our results demonstrate that local delivery of IL-15 and IL-15Rα mRNA to OC tumors may be a safer strategy to boost HPC-NK cell therapy of OC through IL-15 transpresentation.
Journal
|
IFNG (Interferon, gamma) • CD34 (CD34 molecule) • GZMB (Granzyme B) • IL15 (Interleukin 15)
|
Anktiva (nogapendekin alfa inbakicept-pmln)
29d
First-in-human evaluation of memory-like NK cells with an IL-15 super-agonist and CTLA-4 blockade in advanced head and neck cancer. (PubMed, J Hematol Oncol)
CIML NK cells combined with N-803 and ipilimumab to treat head and neck cancer is safe, and associated with a more proliferative NK cell phenotype. However, the combination leads to reduced HLA mismatched NK cell persistence, resulting in an important limitation affecting NK cell combination therapies in clinical trials. These results inform evaluation of CIML NK therapy for advanced malignancies, with considerations for combination with IPI.
P1 data • Journal
|
CD8 (cluster of differentiation 8)
|
Yervoy (ipilimumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • CIML NK
30d
Trial initiation date
|
gemcitabine • Anktiva (nogapendekin alfa inbakicept-pmln) • m-ceNK cells
1m
Case report: PD-L1-targeted high-affinity natural killer cells and IL-15 superagonist N-803-based therapy extend overall survival of advanced metastatic pancreatic cancer patients. (PubMed, Front Oncol)
From late 2019 to 2021, single-patient Investigational New Drug (spIND) protocols for five mPC patients were designed and approved that generally comprised combined Abraxane (nab-paclitaxel) and gemcitabine therapy with experimental therapeutics N-803, PD-L1-targeted high-affinity natural killer (PD-L1 t-haNK) cells, and aldoxorubicin, a serum albumin-binding doxorubicin prodrug. Some patients also received stereotactic body radiation therapy (SBRT), cyclophosphamide, pembrolizumab, nivolumab, and/or experimental ETBX-051 (brachyury) and/or ETBX-061 (MUC1) vaccines...The OS of 13, 26.9, and 23.2 months for three patients is particularly notable. The findings here support the ongoing clinical investigations of N-803 and PD-L1 t-haNK cells in combination therapy.
Journal
|
PD-L1 (Programmed death ligand 1) • MUC1 (Mucin 1) • CA 19-9 (Cancer antigen 19-9)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • gemcitabine • albumin-bound paclitaxel • cyclophosphamide • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-051 • ETBX-061 • PD-L1.t-haNK • aldoxorubicin (INNO-206)
2ms
Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption (clinicaltrials.gov)
P1, N=46, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Apr 2026 --> Dec 2026 | Trial primary completion date: Oct 2025 --> Jun 2026
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
Anktiva (nogapendekin alfa inbakicept-pmln)
2ms
Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation (clinicaltrials.gov)
P2, N=60, Recruiting, Washington University School of Medicine | Trial completion date: Jan 2026 --> Jul 2026 | Trial primary completion date: Jan 2026 --> Jul 2026
Trial completion date • Trial primary completion date
|
cyclophosphamide • Anktiva (nogapendekin alfa inbakicept-pmln)
2ms
Immunotherapy Before and After Surgery (clinicaltrials.gov)
P2, N=20, Not yet recruiting, ImmunityBio, Inc.
New P2 trial
|
Anktiva (nogapendekin alfa inbakicept-pmln) • m-ceNK cells
3ms
New P3 trial • Checkpoint inhibition • Metastases
|
docetaxel • Anktiva (nogapendekin alfa inbakicept-pmln)
3ms
CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov)
P1, N=11, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases • Immune cell
|
Erbitux (cetuximab) • Yervoy (ipilimumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • CIML NK
3ms
Enrollment open • Enrollment change • Checkpoint inhibition
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
|
PD-L1 expression • BRAF V600E • MSI-H/dMMR • PD-L1 overexpression • BRAF V600 • BRAF wild-type
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • docetaxel • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
3ms
QUILT-3.060t: QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (clinicaltrials.gov)
P1/2, N=6, Terminated, ImmunityBio, Inc. | N=80 --> 6 | 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
3ms
QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (clinicaltrials.gov)
P1/2, N=2, Terminated, ImmunityBio, Inc. | Phase classification: P1b/2 --> P1/2 | N=332 --> 2 | Active, not recruiting --> Terminated; low enrollment
Phase classification • Enrollment change • Trial termination • Metastases
|
Erbitux (cetuximab) • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • Stivarga (regorafenib) • 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
Enrollment open • Combination therapy
|
gemcitabine • Anktiva (nogapendekin alfa inbakicept-pmln) • m-ceNK cells
4ms
New P2 trial • Combination therapy
|
gemcitabine • Anktiva (nogapendekin alfa inbakicept-pmln) • m-ceNK cells
4ms
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)
4ms
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
|
IL15 (Interleukin 15)
|
epirubicin • Anktiva (nogapendekin alfa inbakicept-pmln)
5ms
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)
5ms
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
5ms
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)
5ms
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
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL15 (Interleukin 15)
|
Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
6ms
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)
6ms
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)
6ms
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)
6ms
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
6ms
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)
7ms
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)
7ms
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)
7ms
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
|
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
7ms
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
7ms
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)
7ms
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
|
Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011
7ms
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)
8ms
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
8ms
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
8ms
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
8ms
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
|
IL15 (Interleukin 15)
|
Anktiva (nogapendekin alfa inbakicept-pmln)
9ms
Trial suspension
|
PD-L1 (Programmed death ligand 1)
|
Anktiva (nogapendekin alfa inbakicept-pmln) • H1299 lung cancer cell lysate vaccine with Montanide ISA-51 VG adjuvant