Yesterday, Inovio Pharmaceuticals announced it received approval to initiate a Phase I trial of its Zika DNA vaccine GLS-5700, which it said induced robust antibody and T cell responses in small and large animal models during preclinical tests.
The product is being co-developed by Korean firm GeneOne Life Science and made at its Houston, Texas-based subsidiary VGXI which specialises in clinical material for DNA vaccines – immunisation using plasmid DNA genetically-modified to include DNA coding specific proteins from a pathogen.
“DNA vaccines are composed of purified, circular DNA molecules produced by bacterial fermentation,” Christy Franco, business development manager at VGXI told Biopharma-Reporter.com.
“Unlike traditional vaccines that contain dead or weakened virus, DNA vaccines do not contain any viral particles and are therefore much safer for patients. Since they do not require eggs or mammalian cells for production, DNA vaccines are also much safer and faster to manufacture.”
New small scale GMP production plant
The contract manufacturing organisation (CMO) has already provided the clinical material for the first-in-man study, but Franco said it is looking to continue to support the Zika clinical programme through a site expansion completed earlier this month.
The firm has opened a small scale cGMP manufacturing facility at its site in The Woodlands, near Houston, adding fermentation capacities from 10L to 40L and full scale purification of clinical-grade plasmid DNA.
“The motivation behind this expansion was the increasing clinical success of DNA Vaccines and gene therapies, which have led to an increasing demand for VGXI’s highly specialized plasmid production services and extensive experience in this area,” Franco told us.
“The expansion includes an additional, small scale GMP production plant to augment our current large scale facility. The second plant provides greater manufacturing capacity as well as flexibility for multiple client campaigns to run in parallel. It will be critical in allowing VGXI to continue to support clinical programmes such as the one for the Zika vaccine.”