1.1 DNA Therapeutics for Human Use
The primary development focus of naked plasmid therapeutics is angiogenic factors gene therapy. As of now, there are a total of two approved naked plasmid drugs for human use globally: Neovasculgen, launched in Russia in 2011, and Collategene, introduced to the Japanese market in 2019. Several other naked plasmid drugs are currently in the Phase II-III clinical stages. Encoding genes include HGF, VEGF-A, SDF-1 (CXCL12), and among others.
1.2 DNA Therapeutics for Animal Use
Different from human medicines, DNA vaccines have been more successful for animal use, including veterinary and pet.
Approved naked plasmid DNA in human and animal
| Application | Product | Species | Target | Indication | Company | Licensed date/Country |
| Gene therapy | Neovasculgen, Cambiogenplasmid, PI-VEGF165 | Human | VEGF-A | CLI, critical limb ischemia | Human Stem Cell Institute | 2011/ Russia |
| Gene therapy | Collategene, beperminogene perplasmid, AMG0001 | Human | HGF | CLI, critical limb ischemia | AnGes | 2019/Japan |
| Gene therapy | LifeTideSW5 | Swine | Porcine growth hormone-releasing hormone (GHRH) | Increase the number of piglets weaned | VGX Animal Health | 2008/Australia |
| Cancer Immunotherapy | Oncept | Canine | Human tyrosinase | Oral malignant melanoma (OMM) | Merial, Boehringer Ingelheim Animal Health | 2010/USA |
| Antimicrobials | Zelnate | Bovine | CpG motif | Bovine respiratory disease (BRD) due to Mannheimia haemolytica | Bayer Animal Health, Elanco | 2015/USA |
Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Plasmid DNA
- Microbial Strain Engineering and Screening
- Microbial Cell Banking (PCB/MCB/WCB)
- Upstream Process Development
- Downstream Process Development
- Formulation Development
- GMP Manufacturing
- Fill and Finish
- Analytical and Testing
- Regulatory Affairs
Reference:
[1] Pagliari S, Dema B, Sanchez-Martinez A, Montalvo Zurbia-Flores G, Rollier CS. DNA Vaccines: History, Molecular Mechanisms and Future Perspectives. J Mol Biol. 2023 Dec 1;435(23):168297. doi: 10.1016/j.jmb.2023.168297.
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