Montgomery County Judge Jeffrey S. Saltz, said Monday he will rule quickly on Inovio’s request for an emergency injunction forcing one of its partners to provide key manufacturing information needed for the large-scale production of a potential COVID-19 vaccine, according to an article by John George in the Philadelphia Business Journal.
Blue Bell-based Inovio Pharmaceuticals Inc. has sued GeneOne Life Science Inc. of South Korea and its VGXI contract manufacturing unit in The Woodlands, Texas. Inovio is a front runner in development of a vaccine, which is now in human clinical trials. In early March, the Herald had a story about a local scientist’s involvement in the creation of a vaccine.
VGXI manufactured vaccine doses for Inovio’s test runs.
In its lawsuit, the business journal says, Inovio alleges VGXI is “breaching its explicit contractual obligation to transfer critical technology needed to manufacture Inovio’s COVID-19 candidate currently in human phase-I clinical trials and showing significant progress.”
In virtual court testimony, Inovio officials argued VGXI was contractually required to turn over the information it is seeking because it does not have the manufacturing capacity to produce the high volume of doses of DNA-based, COVID-19 vaccine candidate INO-4800. A technology transfer contract with VGXI was canceled in May but VGXI says the the contract did not include the transfer of patented intellectual property.
If Inovio’s experimental vaccine is approved by the Food and Drug Administration, Inovio will need to immediately start distributing up to 100 million doses. Inovio has already made arrangements with other manufacturers but those negotiations are on hold.
Dr. J. Joseph Kim, president and CEO of Inovio Pharmaceuticals, said without the technology transfer his company would be in a bind, according to the Business Journal.
In January, Inovio began preclinical studies of INO-4800 in animal models — and published positive data from those studies last month.
The company subsequently began a phase-I clinical trial testing the safety of INO-4800 in 40 volunteers. One of the test sites is the Perelman School of Medicine at the University of Pennsylvania.
If the phase-I study results are positive, Inovio plans to begin larger, later-stage efficacy studies of its vaccine candidate in the second half of 2020, subject to further regulatory guidance from the FDA.