Inovio will take a trip to sunny Brazil to run a phase 3 trial testing its COVID-19 vaccine, months after the U.S. turned off the lights for the late-stage study.
The Plymouth Meeting, Pennsylvania-based company received authorization from Brazilian health officials to run the phase 3 portion of the phase 2/3 trial, called Innovate, which will test the company’s vaccine INO-4800, according to a Thursday statement.
The news breathed a some life back into Inovio’s shares, which took a major hit after U.S. officials stopped funding for the vaccine candidate back in April. Inovio shares were trading up more than 7% at $9.07 as the markets opened Thursday.
Inovio has run into plenty of trouble with its DNA vaccine candidate, falling well behind chief competitors Pfizer-BioNTech and Moderna. U.S. officials pulled the plug on funding for the biotech as inoculations picked up around the country. Also, in September, the FDA placed Inovio's phase 2/3 on a partial clinical hold.
But Inovio has pressed on, promising a shelf-stable vaccine that could keep at room temperature for up to a year. This would be an improvement over the leading authorized mRNA shots, which have cold storage requirements. Many countries lag behind the U.S. in administering vaccines, so Inovio could find a market if they can get the vaccine through clinical research.
"With many countries in the world experiencing low vaccination rates and seeing an increase in infections, we feel the urgency to advance INO-4800 globally,” said Inovio President and CEO J. Joseph Kim, Ph.D., in the statement.
The phase 3 study will examine the efficacy of two INO-4800 doses administered one month apart in men and women 18 years old and up. The primary endpoint will be virologically confirmed COVID-19. Inovio will conduct the trial in Latin America, Asia and Africa.
Inovio’s phase 2 study was funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and other agencies. The vaccine also received early research funding from the Bill & Melinda Gates Foundation.
INO-4800 was found to be well-tolerated and produced an immune response in adults during earlier studies.
The biotech is also working with Sinovac Biotechnology on two clinical trials testing boosting with INO-4800 and Sinovac’s World Health Organization-approved CoronaVac.
Meanwhile, Pfizer is expecting a whopping $33.5 billion in sales for its now-approved COVID-19 shot, named Comirnaty.