The United States health regulator has suspended Inovio Pharmaceuticals Inc’s plans to begin final testing of its coronavirus vaccine. The US agency asked the drugmaker for more information, including details about a device to be used to inject genetic material into cells., reports Reuters.
The shares of pharmaceutical company Inovio, the second-best performing company on the Nasdaq biotechnology index this year, until last Friday (up more than 400% in 2020), fell 33% before the opening bell on Wall Street. The company hoped to start the final phases of its clinical trials as early as this month.
According to Reuters, the drugmaker explained in a statement on Monday that the “partial pause in clinical trials” imposed by the United States Food and Drug Administration (FDA) was not due to any adverse side effects recorded during the first phase of vaccine clinical trials, that are in progress, unlike what happened with the Astra Zeneca vaccine and the University of Oxford.
Inovio said it will answer questions from the FDA in October, after which the US health agency will have 30 days to decide whether trials should proceed or not.
The company planned to administer the vaccine to trial participants via an electronic device called Cellectra. To do this, Inovio received up to $ 71 million (about € 60 million) in funding from the U.S. Department of Defense to speed up Cellectra’s scale production.
The company advanced encouraging results in June from the initial phase of clinical trials in humans. In August, Inovio revealed that it would begin testing the vaccine, INO-4800, in the intermediate to advanced phases of the trials, after obtaining FDA approval.
Inovio’s development program is already lagging behind rivals such as Moderna Inc, Pfizer Inc and AstraZeneca, all of which have already started the advanced phases of clinical trials of the respective coronavirus vaccine candidates.