Inovio accuses manufacturing partner of hampering COVID-19 vaccine scale-up in lawsuit
Vaccine maker Inovio has had a rough week after the U.S. government left the biotech off its list of candidates most likely to produce a viable COVID-19 shot within the year. Now, the company has taken its frustration out on a longtime manufacturing partner it accused of withholding technical knowledge and killing a scaled-up shot rollout.
Inovio earlier this week accused contract manufacturing partner VGXI, a subsidiary of South Korean Geneone Life Sciences, of refusing to pass technical know-how to CDMOs helping manufacture doses of its COVID-19 vaccine hopeful, according to a lawsuit filed in Pennsylvania state court.
In its suit, Inovio said VGXI did not have the needed manufacturing capacity to produce its vaccine at scale, requiring the transfer of its technical information to speed a regulatory approval. By not doing so, VGXI violated its contract and has kept Inovio’s “vaccine and world health hostage, perhaps to squeeze more money from Inovio or because it’s having buyer’s remorse over its existing contract,” the lawsuit said.
Inovio expects the contractual dispute to be “resolved shortly,” the biotech said in a statement.
VGXI said in a statement that it has been working with Inovio to help produce its DNA vaccine candidate, INO-4800, which is currently in phase 1 human testing, and called the complaint “inaccurate.”
“For reasons unknown to VGXI, rather than continue working with VGXI to achieve accelerated manufacturing levels, Inovio has instead filed this court action to try to take VGXI’s intellectual property,” the CDMO said.
With the backing of $17.2 million from the Coalition for Epidemic Preparedness Innovations (CEPI), Inovio has inked multiple deals to scale manufacturing of its vaccine to 1 million doses by the end of 2020.
In April, the biotech agreed to expand its existing deal with German contract manufacturer Richter-Helms Biologic to flesh out production of the COVID-19 shot using technology transferred from VGXI. Inovio and Richter-Helms have worked together since 2014 to produce Inovio’s HPV vaccine candidate, VGX-3100.
The vaccine maker signed a similar deal with Ology BioServices in late March to scale up clinical supply of the vaccine with funding from an $11.9 million grant from the U.S. Department of Defense.
Inovio has an established relationship with CEPI, which granted the drugmaker up to $56 million over five years in 2018 for its work on Middle East respiratory syndrome (MERS) and Lassa fever vaccine candidates. Despite the government’s repeated backing, Inovio has yet to produce an FDA-approved vaccine.