Item 8.01. Other Events.
On June 3, 2020, Inovio Pharmaceuticals, Inc. (the “Company”) filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania seeking, among other requests for emergency relief, to compel VGXI, Inc. and GeneOne Life Science, Inc. (together, “VGXI”) to facilitate the transfer of manufacturing methods, using VGXI’s technology, under the parties’ existing supply agreement (the “Supply Agreement”). The technology transfer, which the Company has requested as permitted under the Supply Agreement, will allow for the large-scale manufacture of the Company’s product candidateINO-4800, a new vaccine candidate against the disease, known asCOVID-19, caused by the outbreak strain of the coronavirusSARS-CoV-2. The Company believes that widespread availability of its potentialCOVID-19 vaccine, which can only be achieved through accelerated large-scale manufacture following clinical trials and regulatory approval, is essential to combat the ongoing global coronavirus pandemic.
As described in the Company’s Annual Report on Form10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission on March 12, 2020, the Company and VGXI entered into the Supply Agreement in 2008. Under the Supply Agreement, VGXI produces and supplies the DNA plasmids for the Company’s research and early clinical trials for its product candidates. There are no purchase commitments by the Company under the Supply Agreement; rather, terms of purchase are determined on an individual purchase order basis. Under the Supply Agreement, the Company has agreed to treat VGXI as its most favored supplier for DNA plasmids, and VGXI has agreed to treat the Company as its most favored customer.
In January 2020, the Company began preclinical studies ofINO-4800 in an effort to develop a potential vaccine for an urgent public health need. In April 2020, the Company received approval from the U.S. Food and Drug Administration (the “FDA”) to begin a Phase 1 clinical trial ofINO-4800. If the initial safety and immunogenicity data from the Phase 1 trial are acceptable, the Company plans to advance the development ofINO-4800 into later-stage efficacy trials in the second half of 2020, subject to further regulatory guidance from the FDA. The Company has a goal of producing one million doses ofINO-4800 by the end of 2020, with its existing capacity and contract resources, for further clinical trials or emergency use.
VGXI informed the Company that it did 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 ofINO-4800, if it were to be approved for sale. The Company began discussions with other third-party contract manufacturers, as permitted by the Supply Agreement. As previously announced, in March and April 2020, the Company engaged Ology Bioservices Inc. and Richter-Helm BioLogics GmbH & Co. KG to support large-scale manufacturing ofINO-4800. Richter-Helm BioLogics has manufactured the Company’s DNA medicine candidateVGX-3100, currently in Phase 3 trials as a potential treatment for precancerous cervical dysplasia, since 2015 using a process technology that was transferred by VGXI at that time. The Company intends to engage additional contract manufacturers for the production ofINO-4800.
Following notification of VGXI’s insufficient capacity, the Company requested that VGXI provide the necessary technology transfer materials in order to allow its engaged contract manufacturers to proceed with the manufacture ofINO-4800, as required by the Supply Agreement. In May 2020, following further discussions between the parties, VGXI notified the Company of its refusal to undertake the Company’s request, leading the Company to initiate legal proceedings as an emergency action to compel the technology transfer required of VGXI by the Supply Agreement for the planned large-scale manufacture of the Company’sCOVID-19 vaccine candidate.
Forward-Looking Statements
This report contains certain forward-looking statements relating to the Company’s business that involve a number of risks and uncertainties, including statements related to expected development and manufacturing of its vaccine candidateINO-4800. These statements may be identified by introductory words such as “may,” “expects,” “plan,” “believe,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. For such statements, the Company claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including, but not limited to, the risk that the Company may not be able to procure the necessary contract manufacturing capacity in order to sufficiently produceINO-4800 on the planned timeline, as well as other factors discussed in the “Risk Factors” section of the Company’s most recently filed Annual Report on Form10-K or Quarterly Report on Form10-Q, as well as other filings that the Company makes with the SEC from time to time. There can be no assurance that any of the forward-looking information provided herein will be proven accurate.
