Inovio says COVID-19 vaccine candidate safe, effective in mid-stage trial

(Reuters) – Inovio Pharmaceuticals Inc (INO.O) said its COVID-19 vaccine candidate was safe, well-tolerated and produced immune response against the new coronavirus in a mid-stage clinical trial, sending the drug developer’s shares up over 3%.

The trial, which enrolled about 400 participants aged 18 and above, helped the company confirm an appropriate dose for testing in a late-stage Phase 3 trial, Inovio said on Monday.

Inovio has lagged behind rivals in the race to develop a COVID-19 vaccine after the U.S. Food and Drug Administration (FDA) last year put the Phase 3 portion of its mid-to-late stage trial on hold for more information on the device used to deliver the vaccine candidate into skin cells.

Shots from Pfizer Inc (PFE.N) and partner BioNTech SE (22UAy.DE)and Moderna Inc (MRNA.O) received U.S. emergency use authorization as early as late last year, and Johnson & Johnson (JNJ.N) earlier this year.

FILE PHOTO: The word “COVID-19” is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration

Inovio said it plans to use data from the mid-stage trial to answer pending regulatory questions about its delivery device before beginning the Phase 3 portion of the study, on partial hold, after FDA’s approval to proceed.

Last month, the company said the U.S. government pulled the funding for a late-stage study testing its vaccine candidate, citing increasing availability of authorized COVID-19 vaccines, and it would now conduct the trial largely outside the country. read more

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