Inovio Pharmaceuticals, one of the biotechs developing a vaccine to prevent COVID-19, has received the FDA’s OK to start testing its candidate in healthy volunteers.
The Plymouth Meeting, PA-based company, which also conducts research in San Diego, plans to enroll as many as 40 adults across two trial locations. Inovio (NASDAQ: INO) said Monday it anticipated dosing its first patient that day.
The trials are taking place at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia and at the Center for Pharmaceutical Research in Kansas City, MO. Those enrolled in the study will get two doses of INO-4800 four weeks apart. Initial data on the participants’ immune responses and the vaccine’s side effects are anticipated by late summer.
Inovio’s stock price rose 9 percent Monday to $8.44 per share from $7.74 apiece as of market close Friday. As recently as mid-February its stock was trading at under $4 per share.
In January Inovio was awarded a grant of up to $9 million by the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a COVID-19 vaccine, funds its anticipated would support development through Phase 1 testing in the US. Previously CEPI awarded Inovio a grant of up to $56 million for the development of vaccines against Lassa fever, an illness endemic in parts of West Africa, and Middle East respiratory syndrome (MERS), which is caused by one of the seven coronaviruses known to affect people.
In mid-March the Bill & Melinda Gates Foundation awarded Inovio a $5 million grant to speed up testing and production of the battery-powered device it plans to use to deliver INO-4800, Cellectra 3PSP. The device uses electroporation—a short electrical pulse intended to open small pores in the cell—to get the material into cells, where the antigens meant to trigger an immune response will be produced.
Inovio’s longtime manufacturing partner, GeneOne Life Science subsidiary VGXI, expedited INO-4800’s manufacture, testing, and release, and in March the Department of Defense awarded an $11.9 million contract to Ology Bioservices, a contract development and manufacturing organization, to work with Inovio to quickly make its more of the experimental DNA vaccine.
Inovio, with Beijing Advaccine Biotechnology Co., is also advancing the candidate into human tests in China. The company aims to make up to 1 million doses of a potential vaccine by the end of 2020 with its existing resources. Those doses will be for additional clinical trials or emergency use.
Many vaccines inject killed or weakened pathogens into the body to show the immune system examples of what to fight. Inovio’s DNA vaccine uses plasmids to encode cells with antigen that mimic the surface of the virus in order to prompt an immune response.
Other companies working on DNA vaccines for COVID-19 include Sanofi (NYSE: SNY), which is working with the US Biomedical Advanced Research and Development Authority on its development. Sanofi has also expanded an existing partnership with Translate Bio (NASDAQ: TBIO) to pursue a vaccine that deploys messenger RNA (mRNA) to prompt the body’s cell to produce proteins that could treat the disease or spark immunity to it. Moderna (NASDAQ: MNA), which has the most advanced COVID-19 vaccine in testing, is also using mRNA.