Inovio Swoons as Covid Vaccine Trial Slowed on FDA Queries

(Bloomberg) -- Inovio Pharmaceuticals Inc. put a partial hold on a phase 2-3 study of its Covid-19 vaccine after U.S. regulators raised questions about a delivery device used in the inoculation. The shares plunged.

The vaccine maker is working to answer questions from the U.S. Food and Drug Administration about the Cellectra 2000 device used in the trial, Plymouth Meeting, Pennsylvania-based Inovio said Monday in a statement. The hold is not due to any adverse events from the vaccine, Inovio said.

The company plans to respond in October, after which the FDA will have 30 days to notify Inovio with a decision as to whether the trial can proceed. The shares were down 27% at 11:18 a.m. Thursday in New York.

The delay creates a “management credibility challenge” for Inovio, Cantor analyst Charles Duncan said, cutting his rating to neutral from overweight and slashing his price target to $12 from $31.

The FDA “appears increasingly cautious on Covid vaccine programs,” he wrote in a research note, pointing to the FDA recently increasing the number of severe cases of the disease needed to show efficacy as well as the caution with which the agency is handling a hold on AstraZeneca Plc’s vaccine trial. The U.K. company’s international trials were stopped after a volunteer getting its vaccine came down with a spinal cord ailment, and have resumed outside the U.S.

Inovio’s inoculation uses DNA to instruct the body’s cells to produce proteins that spark a protective response. Cellectra 2000 is an electroporation device that uses brief electrical pulses to create small openings in cells that allow injected genetic material to enter more easily.

Inovio said in June that its early-stage study of 40 healthy volunteers found that 94% of trial participants demonstrated overall immune responses at week six after two doses of the vaccine.

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