ImmunityBio, Inc.

IBRX

Held by 1 specialist biotech fund

High short interest · No specialist buying

1 fund opened new positions. Next phase3 readout (N-803 and BCG): Oct 2024. Short interest: 30.9% of float.

BiotechnologyCEO: Richard Gerald AdcockIPO: 2015Website ↗

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.

Catalysts

Phase 2Q2 2013INNO-206Pancreatic Ductal AdenocarcinomaNCT01580397

Phase 2PositiveQ2 2014INNO-206Metastatic Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Unresectable Soft Tissue SarcomaNCT01514188

Phase 2Q2 201650 mg/m2 aldoxorubicinKaposi's Sarcoma, HIV Positive, AIDSNCT02029430

Primary: Objective Response Rate (up to 6 months)Enrollment:15/15Sites: 1RANDOMIZED, TREATMENT

Phase 2Q4 2016250 mg/m2 aldoxorubicinGlioblastomaNCT02014844

Phase 2Q2 2017AldoxorubicinMetastatic Small Cell Lung CancerNCT02200757

Phase 3Q2 2017AldoxorubicinMetastatic, Locally Advanced or Unresectable Soft Tissue SarcomaNCT02049905

Primary: Progression-Free Survival (PFS) (24 months)Enrollment:433/433Sites: 74RANDOMIZED, TREATMENT

Phase 2NegativeQ4 2017CyclophosphamidePancreatic CancerNCT03136406

Phase 2NegativeQ1 2018aNK (NK-92)Stage IIIB Merkel Cell Carcinoma, Stage IV Merkel Cell CarcinomaNCT02465957

Phase 2Q2 2018170 mg/m2 aldoxorubicinMetastatic, Locally Advanced, or Unresectable Soft Tissue SarcomaNCT02235701

Phase 2NegativeQ3 2018Aldoxorubicin HClPancreatic CancerNCT03387098

Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs), Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. (30 days after last dose, up to 8 months)Enrollment:4/4Sites: 1NA, TREATMENT

Phase 2Q1 2019avelumabNon Hodgkin LymphomaNCT03169790

Primary: Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (1 year)0NA, TREATMENT

Phase 2Q1 2019AvelumabHead and Neck Squamous Cell CarcinomaNCT03169764

Phase 2Q1 2019avelumabColorectal CancerNCT03169777

Phase 2Q1 2019AvelumabMerkel Cell CarcinomaNCT03167164

Phase 2Q1 2019avelumabTriple Negative Breast CancerNCT03175666

Phase 2Q1 2019avelumabUrothelial CarcinomaNCT03197571

Phase 2Q1 2019AvelumabMelanomaNCT03167177

Primary: Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03. (1 year)0NA, TREATMENT

Phase 2Q1 2019AvelumabOvarian CancerNCT03197584

Phase 2NegativeQ2 2019Aldoxorubicin HClSquamous Cell CarcinomaNCT03387111

Phase 2NegativeQ2 2019Aldoxorubicin HClPancreatic CancerNCT03586869

Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) (Up to 230 days)Enrollment:3/3Sites: 1NA, TREATMENT

Phase 2NegativeQ2 2019Aldoxorubicin HydrochlorideColorectal Cancer Metastatic, m CRCNCT03563157

Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) (30 days after last dose, up to 6 months or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest.)Enrollment:2/2Sites: 1RANDOMIZED, TREATMENT

Phase 2Q3 2019ETBX-011Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma RecurrentNCT03563170

Primary: Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 4.03 (2 years)0Sites: 1RANDOMIZED, TREATMENT

Phase 2Q4 2019GemcitabineMetastatic Pancreatic CancerNCT03563144

Phase 2Q2 2020LeucovorinTriple Negative Breast Cancer (TNBC)NCT03554109

Primary: Pathological Complete Response Rate (8 months)0Sites: 1RANDOMIZED, TREATMENT

Phase 2Q3 2020Aldoxorubicin HydrochlorideChordoma, Unresectable Malignant NeoplasmNCT03647423

Primary: Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03. (9 weeks)0Sites: 1RANDOMIZED, TREATMENT

Phase 2NegativeQ3 2021AvelumabMerkel Cell CarcinomaNCT03853317

Phase 2Q4 2021hAd5-S-Fusion+N-ETSD vaccineCovid19NCT04845191

Primary: Phase 1 Safety: Incidence of MAAEs and SAEs (through 1 week post final vaccine administration)0RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q4 2021hAd5-S-Fusion+N-ETSD vaccineCovid19NCT04843722

Phase 3NegativeQ2 2022hAd5-S-Fusion+N-ETSDCOVID-19NCT06022224

Primary: Number of Participants With Adverse Events (Up to 7 months (From day 1 to 6 months after last dose))Enrollment:35/35Sites: 1RANDOMIZED, TRIPLE, TREATMENT

Phase 2NegativeQ3 2022N-803Advanced Triple Negative Breast CancerNCT04927884

Primary: Number of Participants With Treatment Emergent Adverse Events (30 days after last dose, up to 65 weeks and 5 days)Enrollment:3/3Sites: 1NA, TREATMENT

Phase 2NegativeQ1 2024AAHI-SC2 VaccineCOVID-19NCT05370040

Phase 3Q4 2024N-803 and BCGBladder CancerNCT03022825

Primary: Complete Response (60 Months)Enrollment:190/190Sites: 28NA, TREATMENT

Phase 2Q1 2025HCW9218Advanced Pancreatic CarcinomaNCT05304936

Primary: Occurrence of Adverse Events and Treatment-Related Adverse Events (12 Months)Enrollment:21/21Sites: 5NA, TREATMENT

Phase 3NegativeQ4 2025NAI + PembrolizumabNon Small Cell Lung CancerNCT03520686

Phase 2Q4 2025N-803Pancreatic CancerNCT04390399

Primary: Progression Free Survival (PFS) (8 weeks)Enrollment:Target 328Sites: 4RANDOMIZED, TREATMENT

Phase 2Q3 2026AnktivaLong COVID, Long COVID Syndrome, Long Covid 19NCT07123727

Primary: Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration. (Through 30 days post final study drug administration.)Enrollment:Target 40Sites: 1NA, TREATMENT

Phase 2Q3 2026BCG (50mg/instillation) + N-803 (400 μg/instillation)Non-muscle Invasive Bladder CancerNCT02138734

Primary: Complete Response (CR) Rate (6 Months)Enrollment:369/369Sites: 108RANDOMIZED, TREATMENT

Phase 2Q4 2026N-803 (IL-15 Superagonist)Long COVIDNCT07108036

Phase 2Q4 2026N-803 and BCGNon-muscle Invasive Bladder Cancer (NMIBC)NCT06829823

Primary: Efficacy of Arms A and B at Month 3 and Month 6 (At Month 3 and Month 6)Enrollment:Target 20RANDOMIZED, TREATMENT

Phase 2Q2 2027CD19 t-haNK- IV AdministrationRelapsed B-Cell Non Hodgkin LymphomaNCT07125872

Phase 2Q2 2027GemcitabinePlatinum-resistant Ovarian CancerNCT06710288

Phase 2Q3 2027Nogapendekin alfa inbakicept (NAI)Sepsis, Septic Shock, LymphopeniaNCT07578558

Phase 2Q4 2027CD19 t-haNK- IV AdministrationRelapsed B-Cell Non-Hodgkin LymphomaNCT07477366

Phase 2Q1 2028Intravesical Recombinant Mycobacterium (rMBCG)NMIBCNCT06800963

Phase 2Q2 2028Nogapendekin alfa inbakicept (NAI)SepsisNCT07783789

Phase 3Q3 2028N-803NSCLC Stage IVNCT06745908

Phase 3Q2 2029Nogapendekin alfa inbakicept (NAI)Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS), SepsisNCT07492875

Phase 2Q3 2029N-803 + PembrolizumabNon-Small Cell Lung Cancer, Small Cell Lung Cancer, Urothelial CarcinomaNCT03228667

Phase 2Q4 2029BevacizumabGlioblastomaNCT06061809

Phase 2Q4 2030Nogapendekin Alfa Inbakicept (NAI)HPV-Positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Head and Neck CancerNCT07628062

Phase 2Q1 2031N-803 (IL-15 Superagonist)High-risk Prostate CancerNCT06765954

Phase 2Q1 2031N-803High-risk Prostate CancerNCT06765902

Phase 3Q2 2032BCG (50 mg) plus ANKTIVA (400 µg)NMIBCNCT07551544

ImmunityBio, Inc.

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