⁍ The U.S. health regulator has put a hold on Inovio Pharmaceuticals Inc’s plans to start final trials of its coronavirus vaccine.

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⁍ The drug developer said on Monday the latest delay due to the FDA’s ‘partial clinical hold’ was not due to any side effects in the early-stage study of the vaccine.

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– The FDA has put a hold on mid-to-late trials of an experimental vaccine designed to fight the deadly strain of coronavirus, sending shares of Inovio Pharmaceuticals down as much as 25%, Reuters reports. The vaccine is being developed using Inovio’s DNA-medicine platform, and the FDA is demanding more information on a delivery device used to inject genetic material into cells. Inovio said it would respond to the FDA’s queries in October, after which the US agency would have 30 days to decide whether the trial should proceed. Tentatively, the earliest the trial could start now is November. “It’s not guaranteed that Inovio will have the all-clear from the FDA to start the trial once it hears back from the agency in November,” an analyst said. Inovio planned to administer the vaccine to study participants through a device called Cellectra, which sends out an electrical pulse to open pores in a cell so DNA molecules can enter. The vaccine focuses on specific genes on the outer ‘spike’ portion of the coronavirus and was designed using Inovio’s DNA medicine platform. The company, which has no approved drug in the market, has received $71 million in funding from the US Department of Defense to scale up manufacturing of Cellectra. When it announced the funding this summer, it said it could expand production beyond its manufacturing plant in San Diego.