Biologics

FDA OKs Resumption of Inovio Covid Vaccine Trial

FDA has authorized Inovio to proceed with the INNOVATE Phase 3 segment for its INO-4800 Covid-19 vaccine candidate. In authorizing the trial, FDA lifted a partial clinical hold after reviewing additional non-clinical, clinical, and device information submitted by the company.

Inovio says the vaccine candidate is composed of a precisely designed DNA plasmid that is injected intradermally followed by electroporation using a proprietary smart device that delivers the DNA plasmid directly into cells in the body and is intended to produce a well-tolerated immune response.

The company is partnering with Advaccine Biopharmaceuticals Suzhou to conduct the INNOVATE Phase 3 segment in multiple countries in the Americas, Asia, and Africa to evaluate the vaccine’s efficacy in a two-dose regimen administered one month apart in men and non-pregnant women age 18 and older.

FDA OKs Resumption of Inovio Covid Vaccine Trial

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