When Inovio joined the race for a COVID-19 vaccine, questions swirled. After all, critics often note, it has pitched into previous pandemics, including Ebola and Zika, but after 40 years in business, the company has failed to get a DNA vaccine—or any product—approved. Now, the FDA has questions, too.
The agency slapped a partial clinical hold on the phase 2/3 study of Inovio’s COVID-19 vaccine because it has “additional questions” about the trial, the company revealed Monday. Details were slim, with the company saying only that the Investigational New Drug (IND) application for the phase 2/3 study would be on hold until the FDA’s questions “have been satisfactorily addressed.”
“The company is actively working to address the FDA’s questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed,” the company said in the statement.
Inovio’s shares were halted Monday morning and fell 33.6% in premarket trading.
The hold is not a response to any side effects seen in the phase 1 study of the vaccine, INO-4800, Inovio said in a statement. That trial, which is testing the jab in 40 healthy people, carries on, as does Inovio’s other work. In addition to vaccines for Ebola and Zika, the company’s pipeline includes programs in other infectious diseases, such as HIV and MERS, as well as cancers, both related and unrelated to HPV.
Inovio’s technology delivers plasmids to cells via injections into the muscle or the skin’s dermis layer, using a hand-held device that opens small pores in the cell with an electrical pulse. The pores, the company claims, open briefly to allow the plasmids to enter, surmounting a hurdle faced by other DNA and mRNA vaccines. Inside the cell, the plasmid DNA instructs the cell’s own machinery to generate antigens to provoke an immune response to prime the body against coronavirus.
Not everyone is buying it. In May, Citron Research, a well-known resource for short sellers, questioned Inovio’s COVID-19 promises in a report, comparing the company to Theranos, the medtech company that promised to deliver diagnoses for many diseases using a single drop of blood. Theranos founder Elizabeth Holmes is facing fraud charges, and the company is now defunct.
Citron’s report was “inflammatory” and inappropriate, Inovio CEO J. Joseph Kim, Ph.D., said in a previous interview, adding: “There’s really no comparison between the two companies,” and that, “We have published almost 150 preclinical and clinical studies in the last 10 years between Inovio and our collaborators.”
Even so, the company’s track record isn’t exactly encouraging. Some industry watchers have wondered why Inovio’s decades of DNA vaccine R&D haven’t parlayed into approved and marketed products. In 2015, it picked up $45 million from the U.S. Defense Advanced Research Projects Agency to develop a DNA vaccine against Ebola as that virus was spreading in Africa. In 2016, Inovio rushed a Zika vaccine into human testing as the mosquito-borne disease took hold in the Americas.
Kim had an answer for that, too: Those vaccines didn’t advance because those diseases waned over time, and resources along with them. That’s not the case with the latest pandemic.
“For COVID-19, we would all agree that this is not going to go away anytime soon,” Kim said.