Erbitux (cetuximab) • Bavencio (avelumab) • cyclophosphamide • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-051 • ETBX-061 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)

10ms

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.

10 months ago

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)

12ms

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

12 months ago

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)

1year

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

1 year ago

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)

1year

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.

1 year ago

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)

over1year

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

over 1 year ago

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)

over1year

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 primary completion date: Jun 2024 --> Oct 2024

over 1 year ago

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)

over1year

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

over 1 year ago

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)

over1year

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

over 1 year ago

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)

over1year

Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer (clinicaltrials.gov)

P2, N=135, Completed, ImmunityBio, Inc. | Unknown status --> Completed | Phase classification: P2b --> P2

over 1 year ago

Trial completion • Phase classification • Metastases

topotecan • aldoxorubicin (INNO-206)

over1year

Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma (clinicaltrials.gov)

P2, N=126, Completed, ImmunityBio, Inc. | Unknown status --> Completed | Phase classification: P2b --> P2

over 1 year ago

Trial completion • Phase classification • Metastases

doxorubicin hydrochloride • aldoxorubicin (INNO-206)

over1year

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

over 1 year ago

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)