Montco Company's COVID Vaccine Approved For Next Phase Of Trials

PLYMOUTH MEETING, PA — After months of preparation following the completion of the first phase of testing, a Montgomery County biopharmaceutical company has received approval from the Federal Drug Administration to move on to Phase 2 of trials for its coronavirus vaccine.

Inovio Pharmaceuticals, based in Plymouth Meeting, is being funded by the U.S. Department of Defense, they said Monday.

"I am extremely proud of the Inovio team, which has been working tirelessly to develop a safe and effective vaccine in the fight against the COVID-19 pandemic," said Joseph Kim, the president and CEO of Inovio. "Initiation of our Phase 2 trial marks a pivotal milestone for INO-4800."

The news comes as Pfizer and BioNTech announced last week a vaccine in Phase 3 with a 90 percent rate of success. While that news was greeted enthusiastically by health professionals around the globe, there are still questions to be answered, and Inovio is among a handful of other companies fast on Pfizer's heels in offering other vaccine options as the fall surge of the virus whips across the nation.

One key difference between Inovio's vaccine and Pfizer's is that Inovio's does not need to be stored at the very cold temperatures of Pfizer's, "making it possible to manufacture at scale and transport without frozen cold chain requirements," Kim added.

Phase 2 will test the efficacy of both a one and two-dose regimen for the vaccine across three age groups: 18 to 50, 51 to 64, and 65 and older. A total of 400 participants in areas deemed "high risk" across 17 states will participate.

Inovio had planned to move to Phase 2 in September, but the FDA placed a temporary hold on Phases 2 and 3 of their trials due to concerns over the vaccine's delivery method, which requires a unique device called a Cellectra. That hold was lifted for Phase 2, but remains in place for a future Phase 3 as final questions are resolved, the company said.

The company previously received $71 million in federal funding in June for mass Cellectra production, as well as a major grant from the Bill and Melinda Gates Foundation.

The Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is funding both Phases 2 and 3, with the goal of prioritizing early doses for active duty service members and civilian personnel.

Phase 3 of the trial will take into account the right dosage determined by Phase 2, officials said. Final results will then look at how many inoculated participants ultimately test positive for coronavirus.

Inovio drew international attention when they announced their DNA-based vaccine in early March, and stated they planned to have a million doses ready by the end of 2020.