Inovio Says COVID-19 Vaccine Candidate Safe, Effective in Midstage Trial

(Reuters) – Inovio Pharmaceuticals Inc 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 and partner BioNTech SE and Moderna Inc received U.S. emergency use authorization as early as late last year, and Johnson & Johnson earlier this year.

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.

The preliminary results from its phase 2 trial were published as a preprint on the medRxiv server on Friday (https://bit.ly/3fb1DaP).

Inovio’s vaccine is based on DNA plasmids that deliver instructions for cells to make a SARS-CoV-2 protein to spur immune responses. The company uses its Cellectra device to deliver the vaccine into the skin with electroporation – a tiny electric charge that helps cells to take in the DNA.

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.

Open https://tmsnrt.rs/3c7R3Bl in an external browser for a Reuters graphic on vaccines in development.

Source: Read Full Article