Biotech firm Inovio Pharmaceuticals has launched a lawsuit against its partner VGXI, claiming the contract development and manufacturing organisation breached their supply agreement by refusing to provide the necessary technology transfer materials to other third-party manufacturers to produce COVID-19 vaccine candidate, INO-4800.
In a US Securities and Exchange Commission filing, Inovio Pharmaceuticals said it filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania on June 3, claiming that the refusal by VGXI, a subsidiary of South Korean Geneone Life Sciences, had blocked its planned manufacturing scale-up and roll-out of the vaccine.
Inovio said that in April 2020, after gaining US Food and Drug Administration approval to begin a Phase 1 clinical trial of INO-4800, it was informed by VGXI “that it did not have the capacity to manufacture the…full order of DNA plasmids on the requested timeline, nor would it be able to manufacture plasmids for the commercial sale of INO-4800, if it were to be approved for sale.”
Inovio claims that in May 2020, after it had begun discussions with other CDMOs – as permitted in the supply agreement -- VGXI notified it of its refusal to initiate the tech transfer.
In a statement, VGXI said it was “surprised” by Inovio’s court filing, claiming the allegations in the complaint were inaccurate.
“VGXI has already manufactured sufficient doses of the vaccine candidate for Inovio’s planned large-scale COVID-19 clinical trials, and VGXI continues manufacturing Inovio’s COVID-19 vaccine candidate,” it said. “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. Inovio is in breach of its obligations under the supply agreement, and VGXI provided Inovio a notice of termination on May 7, 2020. For these and other reasons, VGXI is eager to have this matter resolved in a court of law.”
Inovio plans to enter INO-4800 into later-stage efficacy trials in the second half of 2020 and has targeted one million doses of the vaccine by the end of 2020, with its existing capacity and contract resources, for further clinical trials or emergency use.