Inovio, a US-based biotechnology company backed by the Bill and Melinda Gates Foundation, will launch phase I of the clinical trial of a candidate COVID-19 vaccine.
The US Food and Drug Administration (FDA) had previously accepted the application by Inovio Pharmaceuticals to begin Phase I clinical human testing of its INO-4800 DNA vaccine candidate under the Investigational New Drug program.
The INO-4800 DNA vaccine has shown promising results during experiments with animals by activating the expected immune response, according to studies.
The vaccine candidate of Inovio operates by inserting into a patient’s body a specially engineered plasmid, a genetic element in a cell that can replicate independently of the chromosomes. The plasmid then causes targeted antibodies to be produced by the patient’s cells which attack a specific infection.
While DNA vaccines have been used in veterinary medicine for a wide range of animal infections, approval for human use has yet to be obtained.
However, during Phase, I of the clinical trial, Inovio’s DNA vaccine candidate for Middle East Respiratory Syndrome (MERS) had previously shown promising results.
That said, in recent weeks Inovio has successfully developed thousands of doses of INO-4800 to support its clinical human trials phase I and phase II.
Inovio will administer the INO-4800 DNA vaccine to forty healthy adult volunteers in Philadelphia and Kansas City during Phase I. The firm will track the volunteers ‘immune response over the next few weeks.
When all phases of clinical trials are successful, Inovio has estimated that 1 million doses of INO-4800 will be available for use by the end of the year.
Inovio’s CEO, J. Joseph Kim said:
This is a significant step forward in the global fight against COVID-19. Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods.
Inovio is not the first organization whose candidate vaccine has reached the human testing process. Moderna, a U.S – based biotechnology company, reported last month that it has created the COVID-19 vaccine at an unprecedented pace and will begin clinical trials shortly.
The Coalition for Epidemic Preparedness Innovations (CEPI) awarded $12.5 million to both Inovio and Moderna, along with the University of Queensland, following the Coronavirus outbreak in December last year.
