Eastern PA Company's Coronavirus Vaccine Moving To Phase 2

PLYMOUTH MEETING, PA — Work continues on a coronavirus vaccine at a small biopharmaceutical company in the greater Philadelphia area, which plans to move into Phases 2 and 3 of its trials this month. It's one of many vaccines that is in development around the world, each with different levels of government funding and support, and with differing levels of acknowledgement in the field of vaccine research.

Inovio Pharmaceuticals, headquartered on 660 Germantown Pike in Plymouth Meeting, drew international attention back in early March when they first announced that they hoped to have a million doses of their vaccine ready for distribution by the end of 2020.

Since then, Inovio has progressed through clinical trials on monkeys as well as Phase 1 of human trials on 38 healthy adult volunteers. All participants had "immune system responses" to the vaccine without notable side effects. The volunteers were 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.

The preliminary design of the vaccine was completed almost immediately after Inovio received the genetic sequence of coronavirus from Chinese researchers in January. However, as experts and analysts in the field have noted, Inovio promised a similar "DNA vaccine" during the swine flu outbreak in 2009, but it was never made available to the public.

There is now some skepticism in the field about the viability of Inovio's technology, according to a New York Times report. After seeing its stock skyrocket in March with the announcement of the vaccine and trials, it has since dropped, indicating some level of apprehension in investors. Specifically, critics point to the lack of details in the lab results of the aforementioned Phase 1 human trials.

“The absence of funding, coupled with their ongoing litigation, coupled with the need to scale a device, coupled with the absence of complete Phase 1 data, makes people skeptical,” Stephen Willey, an analyst at the investment firm Stifel, told the New York Times.

Inovio's DNA-based vaccine requires a unique device called a Cellectra in order to administer a dose. The company has received $71 million from the U.S. Department of Defense to manufacture the tool.

But there's still the question of funding the distribution of the vaccine itself, and other related costs and hurdles that stand between bringing something that works in a lab to actually inoculating everyday Americans. Inovio also 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.

However, Dr. J. Joseph Kim, Inovio's president and CEO, 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.

There are already 14 other vaccines which have reached Phase 2 of human trials, according to the New York Times' coronavirus vaccine tracker. Meanwhile, nine have reached Phase 3, which involves more wide scale testing, and three have been approved for some very limited use. There are more than 200 in development around the world, officials say.

The three approved for limited use are all overseas: China's CanSino Biologics and Sinovac Biotech, as well as the Russian Ministry of Health's Gamaleya Research Institute.

The CanSino and Russian vaccines were approved for special use by the Chinese military and Russia, respectively, before Phase 3 ever began. The SinoVac vaccine appears the closest to approval for use by the general public, with an agreement reportedly in place to provide 40 million doses to Indonesia in spring 2021.

An international cooperative effort to develop a safe vaccine is being spearheaded by a group called Covax, side by side by with the World Health Organization. The United States is not currently participating in this initiative because of disagreements with the WHO, according to a Forbes report.

Inovio has prepared thousands of doses already for use in their Phases 2 and 3.