The U.S. Food and Drug Administration has suspended Inovio Pharmaceuticals' plans to begin its third-stage tests of an experimental COVID vaccine as the health regulator seeks more convincing data, including specifics on a device used to administer genetic material into human cells.
The setback means the Phase 2 and 3 tests of the biotech's candidate treatment will not get underway until next month. The company said it's working to address the FDA's concerns, the Wall Street Journal bared.
The agency has up to 30 days to inform Inovio on whether the clinical test can move forward. Tentatively, the soonest the test could commence is November, the company said.
Inovio disclosed on Monday that the delay because of the health regulator's partial clinical hold was not a result of any side effects in its initial phase coronavirus vaccine studies, which is ongoing.
According to Piper Sandler analyst Christopher Raymond, it is not guaranteed that Inovio will have the "all-clear from FDA to begin its tests once the company hears back from the regulator in November," Reuters quoted the analyst as saying.
The company's candidate treatment aims to function by administering human subjects with synthetic DNA to trigger a strong immune reaction. No DNA-based drug has been developed and mass-produced.
Inovio, based out of Pennsylvania, develops its candidate COVID-19 vaccine at the group's San Diego research facility. Globally, over a hundred research firms and private companies are scrambling to produce a vaccine that can safely and effectively contain the disease.
Inovio has been granted $71 million in capital by the U.S. Department of Defense to fast-track its development of Cellectra, a device that generates an electrical charge to create cell pores to enable DNA molecules to penetrate.
The biotech disclosed initial data from its 40-subject Stage 1 test for a potential drug in June this year. Based on the results, the vaccine produced an immune reaction in almost all participants and is proven safe.
