TABLE 3.
Examples of current clinical trials for adenovirus‐based in vivo gene therapies, grouped by indication
| Viral vector | Serotype | Gene of interest | Indication | Name (Sponsor) | Route | Trial number |
|---|---|---|---|---|---|---|
| Cancer (n = 26) | ||||||
| Ad | Ad5 | p53 | Solid tumor | Ad‐p53 (MultiVir, Inc.) | Intratumoral | NCT03544723 (Phase 2) |
| Ad | Ad5 | N/A | Hepatocellular carcinoma | H101 (Sun Yat‐sen University) | Intravenous | NCT03780049 (Phase 3) |
| Ad | Ad5 | N/A | Refractory malignant ascites | H101 (Fudan University) | Intravenous | NCT04771676 (Phase 2) |
| Ad | EnAd | Anti‐CD40 antibody | Metastatic cancer, epithelial tumor | NG‐350A (PsiOxus Therapeutics Ltd) | Intratumoral | NCT03852511 (Phase 1) |
| Ad | Ad VCN‐01 | RB1 | Refractory retinoblastoma | VCN‐01 (Fundació Sant Joan de Déu) | Intravitreal | NCT03284268 (Phase 1) |
| Ad | Ad5 | IL‐12 | Glioblastoma | Ad‐RTS‐hIL‐12 (Ziopharm) | Intratumoral | NCT02026271 (Phase 1) |
| Ad | Ad5/35 | TMZ‐CD40L and 4‐1BBL | Pancreatic cancer | Delolimogene mupadenorepvec (Lokon Pharma AB) | Intratumoral | NCT02705196 (Phase 1/2) |
| Ad | Ad5 | HSV‐tk | Prostate cancer | ADV/HSV‐tk (The Methodist Hospital System) | Intratumoral | NCT03541928 (Phase 2) |
| Ad | Not specified | IL‐12 | Triple negative breast cancer | N/A (The Methodist Hospital System) | Intratumoral | NCT04095689 (Phase 2) |
| Ad | Ad5 | HSV‐tk | Non‐small cell lung cancer | Aglatimagene besadenovec (Candel Therapeutics, Inc.) | Intratumoral | NCT04495153 (Phase 2) |
| Ad | Ad5 | IFNγ | Basal cell carcinoma | ASN‐002 (Ascend Biopharmaceuticals Ltd) | Intratumoral | NCT04416516 (Phase 2) |
| Ad | Ad5 | Fas‐TNFR1 | Glioblastoma | VB‐111 (Dana‐Farber Cancer Institute) | Intravenous | NCT04406272 (Phase 2) |
| Ad | Ad5 | yCD, mutTKSR39rep‐ADP | Pancreas cancer | Ad5‐yCD/mutTKSR39rep‐ADP (Seoul National University Bundang Hospital) | Intratumoral | NCT04739046 (Phase 2) |
| Infectious diseases (n = 53) | ||||||
| Ad | Ad26 | Ebola envelope glycoprotein | Ebola virus disease | Ad26.ZEBOV | Intramuscular | NCT04152486 (Phase 3) |
| Ad | ChAd3 | Ebola virus glycoprotein | Ebola virus disease | ChAd3‐EBO Z, VSVG‐ZEBOV (National Institute of Allergy and Infectious Diseases) | Intramuscular | NCT02344407 (Phase 2) |
| Ad | Ad26 | Spike protein | COVID‐19 | Ad26.COV2.S | Intramuscular | NCT04838795 (Phase 3) |
| Ad | Ad26, Ad5 | Spike protein | COVID‐19 | Gam‐COVID‐Vac | Intramuscular | NCT04564716 (Phase 3) |
| Ad | Ad5 | Spike protein | COVID‐19 | Ad5‐nCoV (CanSino Biologics Inc.) | Intramuscular | NCT04526990 (Phase 3) |
| Ad | ChAd | Spike protein | COVID‐19 | AZD1222 | Intramuscular | NCT04516746 (Phase 3) |
| Ad | Ad | Spike protein | COVID‐19 | BBV154 (Bharat Biotech International Limited) | Intramuscular | NCT04751682 (Phase 1) |
| Ad | ChAd68 | Spike protein | COVID‐19 | ChAdV68‐S, ChAdV68‐S‐TCE (National Institute of Allergy and Infectious Diseases) | Intramuscular | NCT04776317 (Phase 1) |
| Ad | Ad26, Ad5 | Envelope protein | MERS | BVRS‐GamVac (Gamaleya Research Institute of Epidemiology and Microbiology) | Intramuscular | NCT04130594 (Phase 1/2) |
| Ad | Ad26 | Evn sequence, Gag and Pol sequence | HIV infection | Ad26.Mos.HIV, MVA‐Mosaic (Janssen Vaccines & Prevention B.V.) | Intramuscular | NCT02315703 (Phase 1/2) |
| Ad | ChAd | Fusion HBc and HBs antigen | Hepatitis B infection, chronic | ChAd155‐hIi‐HBV (GlaxoSmithKline) | Intramuscular | NCT03866187 (Phase 1) |
| Ad | ChAdY25 | M.tb antigen 85A | TB infection | ChAdOx185A, MVA85A (University of Oxford) | Intramuscular | NCT03681860 (Phase 1/2) |
| Others (n = 3) | ||||||
| Ad | Ad5 | IL‐1Ra | Knee osteoarthritis | FX201, aka humantakinogene hadenovec (Flexion Therapeutics, Inc.) | Intra‐articular | NCT04119687 (Phase 1) |
| Ad | Not specified | VEGF | Coronary artery disease | XC001 (XyloCor Therapeutics, Inc.) | Transthoracic epicardial | NCT04125732 (Phase 1/2) |
| Ad | Not specified | VEGF | Refractory angina pectoris | AdvVEGF‐D (Kuopio University Hospital) | Intramyocardial | NCT03039751 (Phase 1/2) |
Abbreviations: Serotypes: ChAd, chimpanzee adenovirus; EnAd, enadenotucirev. Genes of Interest: 4‐1BB ligand, 4‐1BBL; IL‐12, interleukin; HSV‐tk, herpes simplex virus thymidine kinase; IL‐1Ra, interleukin‐1 receptor antagonist; RB1, RB Transcriptional Corepressor 1; VEGF, vascular endothelial growth factor. Indication: HIV, human immunodeficiency virus; MERS, Middle East Respiratory Syndrome; TB, tuberculosis.