Inovio Pharmaceuticals has asked VGXI to scale-up manufacturing of a potential DNA vaccine against COVID-19 after an initial production run provided materials for a Phase I trial that began this week.
The first dosing of INO-4800, a DNA vaccine candidate designed to prevent COVID-19, took place this week after the US Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application.
The Phase I study of INO-4800 will enroll up to 40 healthy adult volunteers at the Perelman School of Medicine at the University of Pennsylvania and at the Center for Pharmaceutical Research, Kansas City. According to Inovio, study supplies of INO-4800 arrived at the sites last week and each participant will receive two doses four weeks apart.
Image: iStock/Vladislav Novitskiy
The candidate, funded through a Coalition for Epidemic Preparedness Innovations (CEPI) grant, is supported by several partners, including the Wistar Institute, which is providing its DNA technology platform, and synthetic DNA developer Twist Bioscience.
Contract development and manufacturing organization (CDMO) VGXI – a subsidiary of GeneOne Life Science – is also on board and was integral in expediting the manufacture to support the trials, according to spokesperson Christy Franco.
“All aspects of the project were expedited,” she told us, claiming the initial batch of vaccine, which manufactured enough vaccine for thousands of doses, was four times faster than traditional plasmid DNA production. “VGXI’s entire team including process development, manufacturing, QC testing, and quality assurance have worked very hard to make this timeline possible.”
Manufacturing process
DNA vaccines are composed of synthetic, circular DNA plasmids encoding parts of the viral protein. The plasmid DNA is inserted into cells, which are then grown in large fermenters.
“As the cells multiply, they make many copies of the DNA plasmid which is later isolated using VGXI’s proprietary AIRMIX technology and purification process to form the final, highly pure DNA vaccine product,” Franco explained.
Thousands of doses have been produced at the CDMO’s facilities in The Woodlands, Texas, but going forward Inovio is looking to have one million doses of the vaccine available by year-end for additional trials and emergency use.
“VGXI has already been contracted by our client to perform additional manufacturing of the vaccine starting in 2Q of 2020,” Franco confirmed.
VGXI added a pilot plant at its site in December last year, but also laid plans to establish a larger scale facility with commercial capability. The 240,000 square-foot commercial facility will include expanded manufacturing capabilities and multiple flexible production suites.
“We are seeking additional resources to expedite and expand this facility to include dedicated manufacturing capacity for the coronavirus vaccine.”