ImmunityBio Pipeline

Clinical
Disease
Triangle Offense
Trial Sites/Collaborators
Pre-Ind
Phase 1
Phase 2
Phase 3
Phase
Bladder Cancer:
BCG Unresponsive NMIBC Carcinoma In-Situ (CIS)
AnktivaDetails
30 Study Locations (See Clinicaltrials.gov for details)
Phase 3
x

Bladder BCG Unresponsive NMIBC Carcinoma In-Situ (CIS)

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients with BCG Unresponsive High-Grade Non-Muscle Invasive Bladder Cancer

NCT03022825

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Bladder Cancer:
BCG Unresponsive NMIBC Carcinoma Papillary Disease
AnktivaDetails
Phase 2
x

Bladder BCG Unresponsive NMIBC Carcinoma Papillary Disease

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients with BCG Unresponsive High-Grade Non-Muscle Invasive Bladder Cancer

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Lung Cancer:
1L Squamous & Non-Squamous Non-Small Cell Lung Cancer CPI Alone
AnktivaDetails
Phase 3
x

1L Squamous & Non-Squamous Non-Small Cell Lung Cancer CPI Alone

QUILT 3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors

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Lung Cancer:
1L Squamous & Non-Squamous Non-Small Cell Lund Cancer CPI + Concurrent Chemo
AnktivaDetails
Phase 3
x

1L Squamous & Non-Squamous Non-Small Cell Lung Cancer CPI + Concurrent Chemo

QUILT 3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors

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Lung Cancer:
2L or Greater Checkpoint Replased Non-Small Cell Lung Cancer
Anktiva + PD-L1 t-haNKDetails
Hollings Cancer Center at the Medical University of South Carolina
35 Study Locations (See Clinicaltrials.gov for details)
Phase 2
x

2L or Greater Checkpoint Replased Non-Small Cell Lung Cancer

QUILT 3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors

NCT03228667

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Pancreatic Cancer:
3L Metastatic Pancreatic Cancer
Anktiva + Aldox + PD-L1 t-haNKDetails
Hoag memorial Presbyterian Hospital (Newport Beach, Calif.); Avera Cancer Institute (Sioux Falls, SD); Chan Soon-Shiong Institute for Medicine (El Segundo, Calif.)
Phase 2
x

3L Metastatic Pancreatic Cancer

QUILT 88: Combination Immunotherapy Plus SOC Chemotherapy Versus SOC Chemotherapy for First-and-Second Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

NCT04390399

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Pancreatic Cancer:
1L / 2L Metastatic Pancreatic Cancer
Anktiva + Aldox + PD-L1 t-haNKDetails
Phase 2
x

1L / 2L Metastatic Pancreatic Cancer

QUILT 88: Combination Immunotherapy Plus SOC Chemotherapy Versus SOC Chemotherapy for First-and-Second Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

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Breast Cancer:
3L or Greater Triple-Negative Breast Cancer
Anktiva + Aldox + PD-L1 t-haNKDetails
Phase 1
x

3L or Greater Triple-Negative Breast Cancer

NANT Molecularly Informed Integrated Immunotherapy in Subjects with TNBC Who Have Progressed On or After Standard-of-Care Therapy.

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Breast Cancer:
3L or Greater Triple-Negative Breast Cancer
Anktiva + PD-L1 t-haNKDetails
Phase 2
Skin Cancer:
Recurrent Merkel Cell Carcinoma
Aktiva + haNKDetails
University of California San Francisco; University of Miami, Sylvester Comprehensive Cancer Center (Miami, FL); Miami Cancer Institute - Baptist Health (Miami, FL); Washington University School of Medicine in St. Louis (St. Louis, MO); Cleveland Clinic Foundation (Cleveland, OH)
Phase 2
x

Recurrent Merkel Cell Carcinoma

QUILT 3.063: A Study of N-803, haNK and Avelumab in Patients with Merkel Cell Carcinoma that Has Progressed After Checkpoint Therapy

NCT03853317

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COVID-19:
COVID-19 Vaccine Trials: TCELLVACCINE hAd5 S+N (SC+SC, SC+SL & SC+Oral) US Trial
hAd5 S+NDetails
Hoag Memorial Hospital Presbyterian (Newport Beach, Calif.)
Phase 1
x

COVID-19 Vaccine Trials: TCELLVACCINE hAd5 S+N (SC+SC, SC+SL & SC+Oral) US Trial

QUILT 4.001 & QUILT 4.005: COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers

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NCT04591717
NCT04732468


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COVID-19:
COVID-19 Vaccine Trials: TCELLVACCINE hAd5 S+N (SC+SC, SC+SL & SC+Oral) South Africa Trial
hAd5 S+NDetails
University of Cape Town, South Africa
Phase 1
x

COVID-19 Vaccine Trials: TCELLVACCINE hAd5 S+N (SC+SC, SC+SL & SC+Oral) South Africa Trial

ProVIVA-SA-1 & 2: COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults

NCT04710303

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HIV:
HIV ACTG / NIAID: HIV Broadly Neutralizing Antibodies
ceNK: Allogeneic Cytokine Induced Memory-Like Natural Killer CellsDetails
Phase 1
x

HIV ACTG / NIAID: HIV Broadly Neutralizing Antibodies

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

NCT04340596

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HIV:
HIV Thai Red Cross: Reducing HIV Persistence by IL-15
AnktivaDetails
Henry M. Jackson Foundation for the Advancement of Military Medicine Walter Reed Army Institute of Research (WRAIR)
Phase 2
x

HIV Thai Red Cross: Reducing HIV Persistence by IL-15

Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Acute HIV Infection

NCT04505501

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Pre-Clinical
Disease
Triangle Offense
Trial Sites/Collaborators
Pre-Ind
Phase 1
Phase 2
Phase 3
Phase
N-820:
Liquid Tumors: IL-15 Superagonist + Anti DC20 Fusion Protein
IL-15 / CD20 Details
Preclinical
x

N-820: Liquid Tumors: IL-15 Superagonist + Anti DC20 Fusion Protein


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N-809:
Solid Tumors: IL-15 Superagonist + Anti PD-L1 Fusion Protein
IL-15 / PD-L1 Details
Preclinical
x

N-809: Solid Tumors: IL-15 Superagonist + Anti PD-L1 Fusion Protein


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N-830:
Solid Tumors: Tumor Necrosis Targeting (TNT) TNT + TGFb Trap Fusion Protein
TNT / TGFb Details
Preclinical
x

N-830: Solid Tumors: Tumor Necrosis Targeting (TNT) TNT + TGFb Trap Fusion Protein


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N-812
Solid Tumors: Tumor Necrosis Targeting (TNT) TNT + IL-12 Fusion Protein
TNT / IL-12 Details
Preclinical
x

N-812: Solid Tumors: Tumor Necrosis Targeting (TNT) TNT + IL-12 Fusion Protein

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CD19 t-haNK:
Diffuse Large B Cell Lymphoma
CD-19 t-haNK Details
Preclinical
x

CD19 t-haNK: Diffuse Large B Cell Lymphoma


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HER2 t-haNK:
HER2+ Breast Cancer/Gastric Cancer
HER2 t-haNK Details
Preclinical
x

HER2 t-haNK: HER2+ Breast Cancer/Gastric Cancer


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EGFR t-haNK:
EGFR+ Squamous Cell Carcinoma
EGFR t-haNK Details
Preclinical
M-ceNK:
All Solid & Liquid Tumors
M-ceNK Details
Preclinical
x

M-ceNK: All Solid & Liquid Tumors


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Anktiva™ (N-803) is an IL-15RαFc Superagonist, a proprietary therapeutic cytokine designed to induce expansion of native NK and CD8+ T-cells without concurrent stimulation of T-regulatory cells; Aldoxorubicin (Aldox) is a proprietary albumin-bound doxorubicin complex that is designed to preferentially accumulate in a tumor’s low pH environment. Both agents are in late-stage clinical development by ImmunityBio, which has exclusive, worldwide rights to the agents. Avelumab is an FDA approved checkpoint inhibitor marketed by Pfizer.
QUILT stands for QUantum Integrative Lifelong Trial.

How Can ImmunityBio Help You?

Solutions for Patients

ImmunityBio is developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.

Opportunities for Trial Investigators

Natural killer cell-based immunotherapies are key to future cancer treatments. Our investigational NK-92®-engineered cells have demonstrated wide therapeutic potential across multiple tumor types, and, in clinical studies, have proven to be well-tolerated, making them ideal for clinical trial investigations.

Solutions for Research Scientists

Our NK-92® cell line provides a versatile bioanalytical testing solution that helps researchers develop functional killing assays that are more consistent and reliable than donor blood and reporter gene assays.

ImmunityBio is continuously pursuing new immunotherapies designed to attack disease by enhancing the patient’s immune system, not weakening it.