VGXI will make Inovio Pharmaceuticals’ investigational vaccine as part of a collaborative effort to halt the progress of the coronavirus that has recently emerged in Wuhan, China.

At the time of publication, 170 people have died and almost 8,000 people infected by the novel coronavirus (2019-nCoV). Wuhan, the Chinese city where the outbreak began, is under lockdown but cases of infection have been reported across the globe, including in Australia, France, and the US.

There is no specific treatment for the virus, nor a vaccine. And while the World Health Organization (WHO) states “it can take a number of years for a new vaccine to be developed,” it has not stopped a collaboration forming with intentions to accelerate the development of one.

Image: iStock/sofirinaja

Funded through a $9 million Coalition for Epidemic Preparedness Innovations (CEPI) grant, the project hopes to expedite the development of Inovio Pharmaceuticals’ investigative vaccine INO-4800 into human trials.

As part of the collaboration, contract development and manufacturing organization (CDMO) VGXI – a subsidiary of GeneOne Life Science – has been selected to manufacture the DNA vaccine from its facilities in The Woodlands, Texas.

“The genome sequence for 2019-nCoV was published on January 10, 2020,” VGXI spokesperson Christy Franco told Bioprocess Insider.

“This DNA sequence information is used by Inovio and their collaborators at the Wistar Institute to design a synthetic DNA plasmid for manufacturing at VGXI. No viral particles or proteins are involved in the manufacturing process. When delivered as a vaccine, the DNA plasmid can elicit a protective immune response.”

The current and potential future production scales have not been disclosed, but Franco said the CDMO is preparations are underway at this time to begin manufacturing.

Other partners in the project include the aforementioned Wistar Institute, which is providing its DNA technology platform aimed at rapidly translating a vaccine against an emerging virus with pandemic potential, and synthetic DNA developer Twist Bioscience.

Capabilities and experience

According to Franco, VGXI is in a prime position to support this collaboration, having worked on projects to counter other infectious disease.

“VGXI has been manufacturing DNA vaccines for use in human clinical testing for nearly 20 years,” she told us. “VGXI’s DNA manufacturing platform can be rapidly deployed and has been proven at large scales. As one example of VGXI’s capabilities, the company provided expedited manufacturing of a DNA vaccine for Zika virus, enabling the fastest development timeline in history from the initial concept to receipt of FDA approval by its collaborator, GeneOne Life Science.”

VGXI’s capabilities include high purity plasmid preparations for preclinical DNA vaccine along with injectable-grade plasmid DNA suitable for use in human clinical trials. According to the firm, a typical plasmid DNA manufacturing run at VGXI can vary from four to eight months and includes E. coli fermentation scales up to 500 L.

In December 2019, the CDMO opened a GMP-grade mRNA manufacturing unit aimed at supporting projects from initial plasmid construction through linearization, in vitro translation, mRNA purification, and quality control testing.