Inovio Files Complaint to Break Ties With CMO Over COVID-19 Vaccine Production Issues
Inovio Pharmaceuticals was one of the earlier companies to identify a potential vaccine candidate against COVID-19, but the company has run into manufacturing problems that have stymied its development plans, while other biopharma groups have pushed ahead in their own development programs.
Inovio’s development issues for its vaccine candidate have become mired in a conflict with the contract manufacturing organization it has worked with on previous projects. Because of the issues with the CMO, Korea-based VGXI, Inc., Inovio has filed a lawsuit seeking to break the impasse and transfer an existing supply agreement to another agency. VGXI, according to the company’s lawsuit, is unable or unwilling to manufacture its vaccine candidate in large quantities. Inovio has been pushing to develop its vaccine candidate, INO-4800, but without the large-scale manufacturing necessary, the company’s efforts have been slowed down considerably. Inovio had a goal of producing one million doses of INO-4800 by the end of 2020 to support its clinical trials and emergency use. VGXI could not meet that demand.
Inovio and VGXI have been partners since 2008. VGXI produces and supplies the DNA plasmids for Inovio’s research and early clinical trials for its product candidates. Inovio has no purchase commitments under this supply agreement. The company said purchase agreements are determined on an individual purchase order basis. Under the Supply Agreement, Inovio said it agreed to treat VGXI as its most favored supplier for DNA plasmids, and VGXI agreed to treat Inovio as its most favored customer.
As COVID-19 took gripped the world, Inovio began to develop its vaccine candidate and in April, received permission from the U.S. Food and Drug Administration to initiate a Phase I study. As the company eyes a potential Phase II, VGXI informed Inovio that is does not have the capacity to manufacture the company’s 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 achieved regulatory approval.
On June 3, Inovio filed a complaint in the Court of Common Pleas of Montgomery County in Pennsylvania seeking emergency relief to compel VGXI to “facilitate the transfer of manufacturing methods, using VGXI’s technology, under the parties’ existing supply agreement,” the company said in a filing with the U.S. Securities and Exchange Commission. The technology transfer is permitted under the existing supply agreement and, if it goes through, would allow Inovio to find another manufacturer who can meet its needs. When VGXI told the company it did not have the capabilities to meet its demands, Inovio said it began discussions with other third-party contract manufacturers, as permitted by the Supply Agreement. Inovio struck a deal with Ology Bioservices Inc. and Richter-Helm BioLogics GmbH & Co. KG to support large-scale manufacturing of INO-4800 and sought to have VGXI turn over the technology required. VGXI refused, which prompted the lawsuit.
In its filing, Inovio said it believes the widespread availability of INO-4800 is essential in quest to develop a medication against the disease that has been linked to the deaths of more than 390,000 people across the globe, including 108,000 in the United States.