Way back in January, Invoio was among the first groups to get involved in COVID-19 vaccine research under a $9 million grant from the Coalition for Epidemic Preparedness Innovations. Now that the company has advanced to human testing, it’s also scored a much larger contract from the U.S. government for delivery devices.
The U.S. Department of Defense (DOD) inked a $71 million supply deal with the Pennsylvania biotech to manufacture devices that use electrical pulses to deliver the company’s vaccines into the skin. The biotech’s vaccine candidate entered human testing in April, and the company plans to report results from that study this month.
The DOD deal will support manufacturing of Inovio's next-gen Cellectra 3PSP and purchase of its older Cellectra 2000. The new device runs on AA batteries and can “function reliably in challenging environments,” the biotech says, which can be beneficial during pandemics when vaccine demand is extremely high, and in some countries where health systems and supply chains are underdeveloped.
The contract “further supports Inovio's large-scale production of devices and arrays to deliver potentially hundreds of millions of doses of INO-4800 next year to combat the global COVID-19 pandemic,” Inovio CEO Joseph Kim said in a statement
Inovio is among dozens of companies advancing COVID-19 vaccines, with many of pharma’s biggest players also involved. The company has jumped into emerging disease vaccine research during past outbreaks, but its work has yet to deliver an approved vaccine. After reporting phase 1, the company hopes to start a phase 2/3 trial in July, Kim previously told Fierce Biotech.
That company expects that study will take about a year, and Inovio may file for an emergency approval before the trial wraps up, Kim added.
Even as the company moves forward with its COVID-19 vaccine, it's also engaged in a legal fight with a manufacturing partner. In a lawsuit this month, the company accused VGXI, a subsidiary of South Korean Geneone Life Sciences, of hindering the ramp-up by refusing to pass technical know-how to CDMOs so those companies could make doses. In a statement, the biotech said it expected the dispute to be “resolved shortly.”
Inovio’s candidate, a DNA vaccine, is one of 13 COVID-19 programs worldwide in human testing, according to a Monday update from the World Health Organization. Aside from those programs, another 130 are in preclinical stages. Moderna and AstraZeneca are in midstage testing, with phase 3 studies planned to kick off this summer.
As the candidates race forward, one group of analysts recently predicted that “at least one” vaccine could be authorized by the FDA by this November.