Inovio Pharmaceuticals Inc. (NASDAQ: INO) shares soared on Monday after the company provided an update for its coronavirus vaccine candidate. Basically, the firm is pushing forward with its midstage study with the support of the U.S. Food and Drug Administration (FDA).
Accordingly, Inovio received clearance from the FDA to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate.
The planned Phase 2/3 clinical trial, named INNOVATE, is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 and will be conducted in adults in the United States.
One important thing to note is that the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency, will fund this trial.
The Phase 2 segment of the trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 to confirm the more appropriate dose, or doses, for each of three age groups with high risks of infection (18 to 50 years, 51 to 64 years and 65 years and older) for the subsequent Phase 3 efficacy evaluation.
As it stands now, the Phase 3 segment of the trial remains on partial clinical hold until the company satisfactorily resolves the FDA’s remaining questions related to the CELLECTRA 2000 device that will be used to deliver INO-4800 directly into the skin.
Inovio expects to resolve the remaining device questions during the conduct of Phase 2 segment and prior to the start of the Phase 3 segment of the trial.
The Defense Department has agreed to provide funding for both the Phase 2 and Phase 3 segments of the clinical trial, in addition to the $71 million of funding previously announced in June for large-scale manufacturing. Inovio has a market cap of roughly $2.1 billion.
Inovio Pharma stock traded up about 9% on Monday to $12.25, in a 52-week range of $2.25 to $33.79. The consensus price target is $13.29.