In late March, “60 Minutes” featured two under-the-radar biopharma companies that are racing to develop COVID-19 vaccines: Inovio and Moderna. Since then, shares of both companies have doubled. But while Moderna has been able to parlay its market run-up into a planned $1.34 billion secondary offering—along with kudos and major headlines—Inovio has been targeted by short-sellers labeling its executive team “a group of charlatans.”
Inovio CEO J. Joseph Kim, Ph.D., isn’t rattled. Earlier this week, his company released animal data showing its DNA vaccine, INO-4800, generated neutralizing antibodies against SARS-CoV-2, the virus that causes the infection, along with a promise that preliminary data from a phase 1 human trial will be out in June.
“Our 40 volunteers should be getting their second dose by early next week, after the Memorial Day holiday,” he told FierceBiotech. Starting in mid-June, he added, “our team will be working overtime to run all of the assays as rapidly as possible.”
Inovio hopes to start a phase 2/3 efficacy trial in July, Kim added, which would generate long-term efficacy data on INO-4800 in about a year. But if the company has the opportunity to seek approval earlier than that, it will.
“If an emergency approval path is available, based on safety and immune responses to date, we will file for that approval,” Kim said.
So why is doubt swirling around Inovio’s COVID-19 vaccine effort? Critics often point out that the company is 40 years old and has so far failed to get a DNA vaccine—or any product—approved. And before the pandemic, it was struggling: One year ago, AstraZeneca pared down a research partnership with Inovio; a couple of months after that, Inovio slashed a bladder cancer development program along with 28% of its staff.
Earlier this month, Citron Research—a well-known resource for short-sellers—took issue with Inovio’s COVID-19 promises, comparing the company to disgraced blood-testing startup Theranos and predicting its stock would fall to $1. Inovio is currently trading around $14 a share.
Citron’s report was “inflammatory,” said Kim, who added that he found the reference to Theranos and its founder Elizabeth Holmes inappropriate. (Holmes is currently facing fraud charges and her company is defunct.) “There’s really no comparison between the two companies,” Kim said. “We have published almost 150 preclinical and clinical studies in the last 10 years between Inovio and our collaborators.”
Still, some Inovio followers have raised questions about why the company’s many years of DNA vaccine R&D haven’t translated into marketable products. In 2015, the company was awarded $45 million from U.S. Defense Advanced Research Projects Agency (DARPA) to develop a DNA vaccine against Ebola, as that virus was spreading in Africa. And when the mosquito-borne disease Zika was exploding in 2016, Inovio rushed a DNA vaccine into human testing.
Those vaccines didn’t advance, Kim said, due to a combination of the diseases waning over time and a lack of resources. “Zika became irrelevant in North America, and for Ebola, the funding dried up. The market reality and the funding reality keeps us from further development,” he said.
Kim doesn’t envision similar troubles with INO-4800. “For COVID-19 we would all agree that this is not going to go away anytime soon,” he said.
But could Inovio’s funding go away if another player zooms to the front of the development pack?
“No, because we’re keeping pace,” Kim says. “We’re not yet largely funded but we have the potential to demonstrate the clinical benefits of a vaccine in the very near future.”
Perhaps, but Inovio’s COVID-19 vaccine efforts have been overshadowed by Moderna’s progress of late. The two companies’ approaches are similar in that their vaccines are designed to prompt the immune system to recognize and attack the virus based on the spike protein that normally allows it to infect cells. On Monday, Moderna’s stock skyrocketed when it released positive data from a small human trial of its mRNA vaccine, mRNA-1273.
In addition to raising money from the public market, Moderna is set to receive as much as $483 million from the Biomedical Advanced Research and Development Authority (BARDA) for late-stage development and manufacturing of mRNA-1273.
Other players in the COVID-19 vaccine race threaten to knock Inovio out, too. They include AstraZeneca, which picked up $1.2 billion from BARDA for its vaccine development effort Thursday and announced Friday a move into a 10,000-patient phase 2/3 trial. CureVac, Johnson & Johnson and Sanofi are also advancing COVID-19 vaccine candidates.
Kim’s confidence that Inovio will be able to keep up with bigger and better-funded rivals stems largely from its experience developing a DNA vaccine to prevent MERS, which is also a coronavirus. In April, Inovio and its partner, Korea-based GeneOne Life Science, announced positive phase 1 data from a phase 1/2a trial of that vaccine, INO-4700. The company is planning a phase 2 trial in the Middle East, backed by $56 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
CEPI has also provided $17.2 million in funding for Inovio’s COVID-19 vaccine work. The company is working with Richter-Helm BioLogics, a German firm, to prepare for large-scale manufacturing of INO-4800.
As for the critics who doubt Inovio will be able to find a path to market with its vaccine to combat COVID-19, Kim said he has no choice but to ignore them and forge ahead. “Our revenge is going to be our success,” he said. “We want to be successful because there’s such an urgent demand.”