ImmunityBio, Inc. (IBRX)
ImmunityBio, Inc. is a clinical-stage biotechnology firm, founded in 2014 and based in San Diego, California. The company is focused on developing groundbreaking therapies and vaccines designed to treat a wide array of cancers and infectious diseases. Its innovative approach relies on a comprehensive suite of immunotherapy and cell therapy platforms. These advanced technologies include novel antibody-cytokine fusion proteins, synthetically engineered immunomodulators, cutting-edge vaccine technologies, natural killer (NK) cell therapies, and strategies that harness the adaptive (T-cell) immune system. ImmunityBio currently has several therapeutic candidates in advanced clinical development, with agents undergoing Phase II or III trials. These investigational treatments are aimed at various liquid and solid tumors, such as bladder, pancreatic, and lung cancers, as well as significant infectious pathogens including SARS-CoV-2 and HIV. The company actively engages in strategic partnerships, holding collaboration agreements with esteemed organizations like the National Cancer Institute, the National Institute of Deafness and Communication Disorders, and Amyris, Inc. Additionally, ImmunityBio has secured licensing agreements with numerous entities, including CytRx Corporation, EnGeneIC Pty Limited, GlobeImmune, Inc., Infectious Disease Research Institute, Sanford Health, Shenzhen Beike Biotechnology Co. Ltd., Sorrento Therapeutics, Inc., and Viracta Therapeutics, Inc.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
ImmunityBio, Inc.
- Cash runway at this date: 10mo
- Cash runway at this date: 9mo
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
Aldoxorubicin, Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)
Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma
NCT02049905Enrollment433StartJan 2014Primary CompletionMay 2017CompletionMay 2017 - Phase 3Terminated
Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer
NAI + Pembrolizumab, NAI + Nivolumab + Ipilimumab
Non Small Cell Lung Cancer
NCT03520686Enrollment102StartMay 2018Primary CompletionOct 2025CompletionOct 2025 - Phase 3Recruiting
Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In
N-803, Tislelizumab
NSCLC Stage IV
NCT06745908Enrollment507StartOct 2025Primary CompletionSep 2028est.CompletionJan 2029est. - Phase 3Withdrawn
Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia
Nogapendekin alfa inbakicept (NAI), agenT-797
Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS) +3
NCT07492875Enrollment0StartApr 2026est.Primary CompletionApr 2029est.CompletionDec 2029est. - Phase 3Withdrawn
Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC
Drug: Nogapendekin alfa inbakicept (NAI), Pembrolizumab
NSCLC (Advanced Non-small Cell Lung Cancer), Metastatic NSCLC
NCT07524257Enrollment0StartMay 2026est.Primary CompletionMay 2029est.CompletionDec 2029est. - Phase 3Withdrawn
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg)
NMIBC
NCT07551544Enrollment0StartMay 2026est.Primary CompletionMay 2032est.CompletionMay 2032est. - Phase 2/3Active, not recruiting
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
N-803 and BCG, N-803
Bladder Cancer
NCT03022825Enrollment190StartJun 2017Primary CompletionOct 2024CompletionMar 2029est. - Phase 2/3Terminated
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
hAd5-S-Fusion+N-ETSD, Placebo (0.9% (w/v) saline)
COVID-19
NCT06022224Enrollment35StartDec 2020Primary CompletionJun 2022CompletionJul 2023 - Phase 2Completed
Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
INNO-206, Doxorubicin
Metastatic Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma +1
NCT01514188Enrollment126StartJan 2012Primary CompletionApr 2014CompletionDec 2014 - Phase 2Completed
Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer
INNO-206
Pancreatic Ductal Adenocarcinoma
NCT01580397Enrollment15StartMay 2012Primary CompletionMay 2013CompletionJul 2013 - Phase 2Completed
Phase 2 Study to Investigate the Efficacy and Safety of Aldoxorubicin in Subjects With Glioblastoma
250 mg/m2 aldoxorubicin, 350 mg/m2 aldoxorubicin
Glioblastoma
NCT02014844Enrollment28StartMar 2014Primary CompletionDec 2016CompletionDec 2016 - Phase 2Completed
A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma
50 mg/m2 aldoxorubicin, 100 mg/m2 aldoxorubicin
Kaposi's Sarcoma, HIV Positive +1
NCT02029430Enrollment15StartApr 2014Primary CompletionApr 2016CompletionApr 2016 - Phase 2Completed
Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer
Aldoxorubicin, Topotecan
Metastatic Small Cell Lung Cancer
NCT02200757Enrollment135StartApr 2015Primary CompletionMay 2017CompletionMay 2017 - Phase 2Terminated
QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)
aNK (NK-92), aNK (NK-92) + N-803
Stage IIIB Merkel Cell Carcinoma, Stage IV Merkel Cell Carcinoma
NCT02465957Enrollment7StartSep 2015Primary CompletionMar 2018CompletionMar 2018 - Phase 2Active, not recruiting
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
N-803 + Pembrolizumab, N-803 + Nivolumab
Non-Small Cell Lung Cancer, Small Cell Lung Cancer +11
NCT03228667Enrollment40StartDec 2018Primary CompletionAug 2029est.CompletionDec 2030est. - Phase 2Withdrawn
QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine
Leucovorin, 5-Fluorouracil
Triple Negative Breast Cancer (TNBC)
NCT03554109Enrollment0StartSep 2018est.Primary CompletionJun 2020est.CompletionFeb 2022 - Phase 2Withdrawn
QUILT-3.088: NANT Pancreatic Cancer Vaccine
Gemcitabine, Nab-paclitaxel
Metastatic Pancreatic Cancer
NCT03563144Enrollment0StartAug 2018est.Primary CompletionDec 2019est.CompletionFeb 2022 - Phase 2Withdrawn
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
Nab-paclitaxel, Cisplatin
Non Small Cell Lung Cancer
NCT03574649Enrollment0StartJun 2018est.Primary CompletionAug 2018est.CompletionAug 2018 - Phase 2Terminated
QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy
Avelumab, N-803
Merkel Cell Carcinoma
NCT03853317Enrollment9StartFeb 2020Primary CompletionSep 2021CompletionSep 2022 - Phase 2Active, not recruiting
Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
N-803, Aldoxorubicin HCl
Pancreatic Cancer
NCT04390399Enrollment328StartJul 2020Primary CompletionOct 2025CompletionMay 2026est. - Phase 2Active, not recruiting
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma
Bevacizumab, PD-L1 t-haNK
Glioblastoma
NCT06061809Enrollment34StartAug 2024Primary CompletionDec 2029est.CompletionDec 2030est. - Phase 2Recruiting
A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer
Gemcitabine, N-803
Platinum-resistant Ovarian Cancer
NCT06710288Enrollment20StartNov 2024Primary CompletionMay 2027est.CompletionMay 2027est. - Phase 2Withdrawn
Immunotherapy Before and After Surgery
N-803, ETBX-071
High-risk Prostate Cancer
NCT06765902Enrollment0StartDec 2025est.Primary CompletionJan 2031est.CompletionJun 2031est. - Phase 2Withdrawn
Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.
N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus)
High-risk Prostate Cancer
NCT06765954Enrollment0StartDec 2025est.Primary CompletionJan 2031est.CompletionJun 2031est. - Phase 2Not yet recruiting
Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
N-803 and BCG, N-803 and Gemcitabine
Non-muscle Invasive Bladder Cancer (NMIBC)
NCT06829823Enrollment20StartNov 2025est.Primary CompletionNov 2026est.CompletionNov 2029est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | Aldoxorubicin, Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide) | NCT02049905 |
| Phase 3 | Terminated | NAI + Pembrolizumab, NAI + Nivolumab + Ipilimumab | NCT03520686 |
| Phase 3 | Recruiting | N-803, Tislelizumab | NCT06745908 |
| Phase 3 | Withdrawn | Nogapendekin alfa inbakicept (NAI), agenT-797 | NCT07492875 |
| Phase 3 | Withdrawn | Drug: Nogapendekin alfa inbakicept (NAI), Pembrolizumab | NCT07524257 |
| Phase 3 | Withdrawn | BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg) | NCT07551544 |
| Phase 2/3 | Active, not recruiting | N-803 and BCG, N-803 | NCT03022825 |
| Phase 2/3 | Terminated | hAd5-S-Fusion+N-ETSD, Placebo (0.9% (w/v) saline) | NCT06022224 |
| Phase 2 | Completed | INNO-206, Doxorubicin | NCT01514188 |
| Phase 2 | Completed | INNO-206 | NCT01580397 |
| Phase 2 | Completed | 250 mg/m2 aldoxorubicin, 350 mg/m2 aldoxorubicin | NCT02014844 |
| Phase 2 | Completed | 50 mg/m2 aldoxorubicin, 100 mg/m2 aldoxorubicin | NCT02029430 |
| Phase 2 | Completed | Aldoxorubicin, Topotecan | NCT02200757 |
| Phase 2 | Terminated | aNK (NK-92), aNK (NK-92) + N-803 | NCT02465957 |
| Phase 2 | Active, not recruiting | N-803 + Pembrolizumab, N-803 + Nivolumab | NCT03228667 |
| Phase 2 | Withdrawn | Leucovorin, 5-Fluorouracil | NCT03554109 |
| Phase 2 | Withdrawn | Gemcitabine, Nab-paclitaxel | NCT03563144 |
| Phase 2 | Withdrawn | Nab-paclitaxel, Cisplatin | NCT03574649 |
| Phase 2 | Terminated | Avelumab, N-803 | NCT03853317 |
| Phase 2 | Active, not recruiting | N-803, Aldoxorubicin HCl | NCT04390399 |
| Phase 2 | Active, not recruiting | Bevacizumab, PD-L1 t-haNK | NCT06061809 |
| Phase 2 | Recruiting | Gemcitabine, N-803 | NCT06710288 |
| Phase 2 | Withdrawn | N-803, ETBX-071 | NCT06765902 |
| Phase 2 | Withdrawn | N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus) | NCT06765954 |
| Phase 2 | Not yet recruiting | N-803 and BCG, N-803 and Gemcitabine | NCT06829823 |
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