U.S. officials have pulled the plug on funding a phase 3 trial for Inovio’s COVID-19 vaccine, telling the biotech that another vaccine is no longer needed as inoculations pick up around the country.
The Plymouth Meeting, Pennsylvania-based biotech’s shares tumbled around 28% on the news as the market opened, dropping to $6.60 from $9.13 the day before.
Inovio was hoping to offer a vaccine that would be stable at room temperature for up to a year, a crucial attribute in the early days of vaccine development as both the Pfizer-BioNtech and Moderna vaccines that made it to market first have extreme cold storage requirements.
But the world figured out the storage problem. More than a quarter of all Americans are now fully vaccinated—leaving little room for Inovio’s product at this time. All Americans 16 years and older are now eligible to receive a vaccine.
The Department of Defense (DOD) put up funding for the phase 2 and 3 portions of Inovio’s trial for INO-4800 called Innovate. Earlier in April, Inovio said the candidate had shown effectiveness against several of the prominent variants that have spread rapidly in the later waves of the pandemic. The funding specifically came from DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.
Funding will continue for the ongoing phase 2 trial as originally planned, Inovio said.
"The decision results from the changing environment of COVID-19 with the rapid deployment of vaccines,” the JPEO-CBRND said in correspondence shared by Inovio on April 23. “This decision is not a reflection of the awardee or product, rather a fast-moving environment associated with the former Operation Warp Speed on decisions related to future products."
Inovio will now seek a location outside of the U.S. to conduct a phase 3 trial for INO-4800 with Chinese partner Advaccine and the International Vaccine Institute. The company has a second COVID-19 candidate called INO-4802 that has been dubbed a “pan-variant” vaccine.
“INOVIO remains well-positioned to support both pandemic and endemic vaccine needs with INO-4800 and INO-4802,” the company said.
The phase 2/3 trial for INO-4800 was placed on hold by the FDA in September 2020, with the agency raising questions about the Cellectra 2000 delivery device that would be used.
Inovio says the 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 technology has been questioned and Inovio does not have a single approved product after decades of DNA vaccine R&D. The company previously inked other contracts with the U.S. government to develop vaccines for Ebola and Zika, neither of which made it to market.