Inovio Pharmaceuticals is an American biotechnology company focused on the discovery, development, and commercialization of synthetic DNA products for treating cancers and infectious diseases. In April 2020, Inovio was among some 100 companies, academic centers, or research organizations developing a vaccine candidate for treating people infected with COVID-19, with more than 170 total vaccine candidates in development.
Technology
The Inovio technology is based on inserting engineered DNA into cells where it becomes incorporated into proteins involved in the immune response to cancers and viruses by producing T cells and antibodies that aid recovery from infection. The technology can be "targeted" to specific types of cancer and immune diseases, such as those produced by a virus. During a meeting of the White House Coronavirus Task Force in March 2020, CEO, Joseph Kim, said that Inovio scientists had designed a vaccine candidate for the COVID-19 coronavirus in January in just three hours after the virus genetic sequence was first published.
Cellectra injection device
To facilitate use of its potential products, Inovio manufactures a proprietary injection device, called "Cellectra", which the company describes as providing a "brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA." In June 2020 - in anticipation of the Inovio COVID-19 vaccine candidate becoming successful - the US Department of Defense invested million to further develop Cellectra as a handheld device and to preorder an undisclosed number of the devices.
Vaccine development
In a 2016 dose-escalation Phase I clinical trial to assess safety after intramuscular injection in healthy adults, the Inovio vaccine candidate, INO-4700, proved to be safe with only mild symptoms and no adverse effects. The trial also demonstrated immunogenicity by dose-independent immune responses detected in more than 85% of subjects after two vaccinations that were durable a year later. In February 2020 after receiving details of the genetic sequence of the coronavirus, Inovio announced that it had produced a preclinicalDNA-based vaccine as a potential therapy for COVID-19. Inovio is in competition to develop a coronavirus vaccine with numerous other companies, which were conducting preclinical or early-stage human research on more than 170 vaccine candidates, as of late June. In April 2020, Inovio began a Phase I trial of the COVID-19 vaccine candidate, INO-4800.
Inovio is collaborating with Beijing Advaccine Biotechnology Co., a Chinese biotech firm, in order to speed its acceptance by regulatory authorities in China, with plans to begin human clinical trials of a candidate vaccine in China during the first half of 2020. Inovio has partnerships with manufacturers to scale up production of a vaccine if preliminary efficacy trials are successful. In April 2020, the company began human Phase I safety studies of its lead vaccine in the United States, and a Phase I-II trial in South Korea, to test for immunization against the COVID-19 virus. In early June, Inovio partnered with the International Vaccine Institute and Seoul National University, South Korea, to advance human research on INO-4800 in a Phase I-II safety and efficacy trial to be conducted on 120 participants at Seoul National University Hospital beginning in June. The trial is funded by the Coalition for Epidemic Preparedness Innovations and supported by the Korea Centers for Disease Control and Prevention and the Korea National Institute of Health.