Inovio Pharmaceuticals filed suit against VGXI, a subsidiary of South Korea’s GeneOne Life Sciences, last month, accusing it of not transferring technical details pertaining to manufacturing doses of INO-4800, Inovio’s DNA vaccine compound with promising results against SARS-CoV-2.
Inovio details in the lawsuit that VGXI does not possess the capacity to scale up manufacturing, which is essential for regulatory clearance.
The production issue is vital for the U.S. to gain control of the virus since its resurgence in recent weeks. Herd immunity will require immunizing 60% to 80% of the population.
“We don’t know which vaccines will be successful. This process is typically sequential,” David Simchi-Levi, director of the MIT Data Science Lab and professor of engineering systems, told Supply Chain Dive. After lab testing, researchers move to animal testing and ultimately to humans. Then they build up manufacturing capability depending on the vaccine technology used. “We cannot afford a sequential process. We need to start the manufacturing capacity today, and the problem is it requires significant investment,” he said.
GeneOne Life Science, Inc. is headquartered in Seoul, South Korea. The company is focused on gene-based therapies and vaccines, and its shares are listed on the Korean KOSPI index. GeneOne’s focus into biotechnology began in 2005 and was associated with a change in name from Dong-Il Fabric to VGXI International, Inc. The company was re-named as GeneOne Life Science, Inc. in 2014 to better reflect the core mission of the company.
GeneOne’s financial HQ and R&D group are based in Seoul, and its global clinical development group is based in Blue Bell, PA, USA. VGXI, Inc., a wholly owned subsidiary of GeneOne is based in Woodlands, TX, USA and it is well known as the largest pure-play Contract Manufacturing Organization supplying cGMP grade DNA plasmids, and soon cGMP mRNA, for clinical use.
“Inovio got greedy. It saw the opportunity to reap vast riches and keep its stock price soaring if it could win the race to a COVID-19 vaccine, but Inovio did not want to pay VGXI for the manufacturing,” VGXI said in response to the lawsuit.
VGXI also alleges that Inovio chose to unfairly take possession of VGXI’s proprietary technology and manufacturing processes and pass on to as many as 10 other manufacturers around the world, including in China and India.