Inovio Pharmaceuticals (Nasdaq: “INO”) reports the company’s on track to commence mid-stage study of its INO-4800 vaccine targeting SARS-CoV-2, the virus behind the COVID-19 pandemic. During a first-quarter analyst call this past Monday, the company reports an unprecedented global collaboration is underway in a bid to develop a successful vaccine product. It has been a whirlwind since the advent of the pandemic: in eighty-three days, the company has gone from laboratory development to its first human dosing. Its stock has been on a roller coaster ride over the last few months: from a low of $3.19 in Feb to a high of $14.59 in April—today it sits at $13.37.
CEO J Joseph Kim reported ongoing engagement with existing funders—from government entities to private financiers—including the U.S. Department of Defense, The Coalition for Epidemic Preparedness Innovations and the Bill & Melinda Gates Foundation.
The vaccine sponsor’s study requires extensive collaboration with labs to contact manufacturers to continue ongoing investigations into safety and efficacy while preparing for manufacturing capacity. The Philadelphia Business Journal reports locally the team has engage with the Wistar Institute and the University of Pennsylvania.
INO-4800 is INOVIO’s DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was designed using INOVIO’s proprietary DNA medicine platform rapidly after the publication of the genetic sequence of the coronavirus that causes COVID-19. INOVIO has deep experience working with coronaviruses and is the only company with a Phase 2a vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).
Phase I Study
The sponsor completed the first of two doses on 40 healthy participants in April in the Phase I clinical trial testing INO-4800 at the University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City, MO.
Based at the company’s lab In Kate E. Broderick serves the company as vice president for research and development reported that the sponsor is on track for all full second dosing of all participants by the last week of May. She noted in the analyst call that preliminary safety data and immunogenicity data will be complete by late June.
Barbara Bradshaw serves as the Program Manager for the study site in Kansas City. While at the University of Pennsylvania, Eileen Donaghy serves as a contact liaison. Inovio’s Shu Ping Yang, MD, PhD, serves as overall study director.
Phase I Activity in Asia
Inovio reports that it will initiate Phase I clinical trials in China and South Korea in the summer. They are working with partners in those parts of the world including Advaccine for China and IVI in South Korea reported the Philadelphia Business Journal.
Phase II Clinical Trial
With Moderna just announcing FDA Fast Track designation and rapid preparations for a Phase II clinical study Inovio also readies to progress to the next study step—a Phase II/III efficacy trial that could potentially start, according to Ms. Broderick, “in the July, August time frame.” This Phase II study will include frontline health care workers as participants in a national, multi-center trial.
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