TABLE 4.
Examples of current clinical trials for herpes simplex virus (HSV)‐based in vivo gene therapies, grouped by indication
| Viral vector | Serotype | Gene of interest | Indication | Name (Sponsor) | Route | Trial number |
|---|---|---|---|---|---|---|
| Cancer (n = 44) | ||||||
| HSV | HSV1 | GM‐CSF | Soft tissue sarcoma | Talimogene Laherparepvec (Amgen) | Intratumoral | NCT04599062 (Phase 1/2) |
| HSV | HSV1 | GM‐CSF | Breast cancer | Talimogene Laherparepvec (Honsson Comprehensive Cancer Center) | Intratumoral | NCT04185311 (Phase 1) |
| HSV | HSV1 | GM‐CSF | Melanoma | Talimogene Laherparepvec (Amgen) | Intratumoral | NCT04427306 (Phase 2) |
| HSV | HSV1 | GM‐CSF | Peritoneal surface malignancies | Talimogene Laherparepvec (Duke University) | Intratumoral | NCT03663712 (Phase 2) |
| HSV | HSV1 | GM‐CSF | Triple negative breast cancer and colorectal cancer with liver metastases | Talimogene Laherparepvec (Amgen) | Intratumoral | NCT03256344 (Phase 1) |
| HSV | HSV1 | GM‐CSF | Rectal cancer | Talimogene Laherparepvec (National Cancer Institute) | Intratumoral | NCT03300544 (Phase 1) |
| HSV | HSV1 | GM‐CSF | Pancreatic cancer | Talimogene Laherparepvec (Amgen) | Intratumoral | NCT03086642 (Phase 1) |
| HSV | HSV1 | GM‐CSF | Hepatocellular carcinoma | Talimogene Laherparepvec (Amgen) | Intratumoral | NCT02509507 (Phase 1/2) |
| HSV | HSV2 | GM‐CSF | Solid tumor, gastrointestinal cancer | OH2 (Wuhan Binhui Biotechnology Co., Ltd.) | Intratumoral | NCT03866525 (Phase 1/2) |
| HSV | HSV1 | CYP2B1 | Liver metastases, primary liver cancers | rRp450 (Massachusetts General Hospital) | Intra‐hepatic artery | NCT01071941 (Phase 1) |
| HSV | HSV1 | Anti‐CTLA‐4 antibody, CD40 ligand, and 4‐1BBL | Advanced solid tumor | RP3 (Replimune Inc.) | Intratumoral | NCT04735978 (Phase 1) |
| HSV | HSV1 | IL‐12 | Recurrent malignant glioma | M032 (University of Alabama at Birmingham) | Intratumoral | NCT02062827 (Phase 1) |
| HSV | HSV1 | Fusogenic protein (GALV‐GP‐R−) and GM‐CSF | Advanced squamous skin cancer | RP1 (Replimune Inc.) | Intratumoral | NCT04050436 (Phase 2) |
| HSV | HSV1 | Thymidine Kinase‐m2 and GM‐CSF | Hepatocellular carcinoma | GEN2 (GenVivo, Inc.) | Intravenous | NCT04313868 (Phase 1) |
| Others (n = 2) | ||||||
| HSV | HSV1 | TGM1 | TGM‐1 related autosomal recessive congenital ichthyosis | KB105 (Krystal Biotech, Inc.) | Topical | NCT04047732 (Phase 1/2) |
| HSV | HSV1 | COL7 | Dystrophic epidermolysis bullosa | KB103 (Krystal Biotech, Inc.) | Topical | NCT03536143 (Phase 1) |
Abbreviations: Genes of Interest: 4‐1BBL, 4‐1BB ligand; COL7, collagen type VII; GM‐CSF, Granulocyte‐macrophage colony‐stimulating factor; IL‐12, interleukin‐12; TGM1, transglutaminase 1.