Human Trials Begin On Coronavirus Vaccine Made In Montgomery Co.

PLYMOUTH MEETING, PA — A Montgomery County-based biopharmaceutical company has begun human trials on a coronavirus vaccine.

Inovio Pharmaceuticals, headquartered on 660 Germantown Pike in Plymouth Meeting, plans to give the first dose of their vaccine to human volunteers on Monday, April 6, the company announced.

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The company, which has been on the forefront of the world effort to develop a vaccine since the outbreak began, had previously said in early March that they hoped one million doses of the vaccine would be ready for mass distribution by the end of 2020.

Phase 1 clinical testing will involve up to 40 healthy adult volunteers spread across two different testing locations, one at the Perelman School of Medicine at the University of Pennsylvania, and another at the Center for Pharmaceutical Research in Kansas City, Missouri.

"This is a significant step forward in the global fight against COVID-19," Dr. J. Joseph Kim, Inovio's president and CEO, said in a statement. "Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing."

The DNA-formulated vaccine was put together in early January, within three hours after the publication of the genetic sequence of coronavirus, according to Inovio.

Since then, the lengthy vaccine production process has been accelerated. Animal studies showed "promising" immune system responses, the company said.

During the human trials, each volunteer will receive two doses of the vaccine — labeled INO-4800 — four weeks apart. Initial data on immune response and basic safety information are expected by the end of the summer.

Organizers in Philadelphia said they did not anticipate having any trouble finding enough volunteers.

"We anticipate rapid enrollment of this initial study," Pablo Tebas, professor of medicine at the Hospital of the University of Pennsylvania the study's principal investigator, said in a statement. "There has been tremendous interest in this vaccine among people who want to do what they can to help protect the greater public from this pandemic as soon as possible."

This comes as scientists at UPMC and University of Pittsburgh School of Medicine released details about their own in-progress vaccine last week. That vaccine "goes on like a Band-Aid," doesn't require refrigeration and could be massed produced rapidly to battle the global pandemic.

UPMC has approached the U.S. Food and Drug Administration about beginning clinical trials for the vaccine and UPMC officials expressed hope that the vaccine could be tested on people within a few months.

The vaccine - called PittCoVacc, short for Pittsburgh Coronavirus Vaccine — uses lab-made pieces of viral protein to build immunity. It is delivered by a microneedle array to increase potency. Trials would take at least a year, and perhaps longer.

Thousands of doses of the Inovio vaccine have already been produced to support Phase 1 and 2 of human trials. In the meantime, the company is working to scale up production of the vaccine, and restated their goal of producing a million doses by the end of the year.

However, Kim noted that "new levels of collaboration and investment between industry and government" would be needed to continue to produce enough vaccines to meet global need, as production costs are high.

Inovio compared their vaccine for COVID-19 to what they developed for Middle East Respiratory Syndrome (MERS), which created a powerful antibody response in about 95 percent of test subjects.

Inovio received a $9 million grant in January from the Coalition for Epidemic Preparedness Innovations to help them develop the vaccine, as well as funding from the Bill and Melinda Gates Foundation.

As of late Sunday, Pennsylvania has 11,510 positive cases of COVID-19, along with 150 deaths.

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