(Reuters) – Inovio Pharmaceuticals Inc is focused on launching the global late-stage trial of its COVID-19 vaccine candidate next month, chief executive Joseph Kim said in a call, with the drug developer expecting trial data in the first half of next year.
In May, Inovio said it would begin the study of INO-4800 in summer this year, after the vaccine candidate was found to be safe and well-tolerated, and produced an immune response against the new coronavirus in a mid-stage clinical trial.
The company started developing INO-4800 last year, but fell behind rivals after the U.S. Food and Drug Administration (FDA) put a part of the U.S. study on hold for more information on the vaccine delivery device.
INO-4800 is a DNA plasmid-based vaccine that is delivered into the skin with a small electrical charge by the company’s proprietary Cellectra electroporation device.
The FDA’s decision was followed by the U.S. government pulling funding for the late-stage study, citing the fast-moving environment of vaccine development.
The global trial will initially focus on Latin America, Asia Pacific and regions in Africa, the company said.
“We were initially focusing on Latin America and Asia Pacific, but looking at the rapidly changing vaccination rates and the virus epidemiology, we are including regions in Africa,” a company executive said during a post-earnings call on Monday.
Inovio, which has no approved drug on the market, has so far received about $85 million in combined funding from the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation and the U.S. Department of Defense for the advancement and manufacture of INO-4800.
Earlier this year, Inovio expanded a partnership with China’s Advaccine Biopharmaceuticals to conduct the late-stage trial. Under the expanded deal, the companies expect to equally share its total cost.
China’s medical product regulator has approved two Advaccine -sponsored clinical trials to study the safety and ability to elicit immune responses of the combined use of the INO-4800 and a vaccine from China’s Sinovac Biotech, Inovio said in a press release.
Click https://tmsnrt.rs/3lwr2Ak for a Reuters graphic on vaccines in development.
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