India Launches Clinical Study for Pennsylvania's COVID-19 Vaccine

Pennsylvania-based INOVIO announced that it had received authorization from the Drug Controller General of India to proceed with the Phase 3 segment of INOVIO's global Phase 2/3 clinical trial for INO-4800, its DNA vaccine candidate for COVID-19.

India's regulatory authorization in India follows similar actions in Brazil, Colombia, Mexico, and the Philippines.

The global Phase 3 segment of INNOVATE study will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in 2-to-1 randomization in men and non-pregnant women 18 years of age and older.

The primary endpoint of this case-driven Phase 3 trial is virologically confirmed symptomatic COVID-19.

"INOVIO is pleased to receive regulatory authorization to proceed with our efficacy Phase 3 trial in India," said Dr. J. Joseph Kim, President, and CEO of INOVIO, in a press statement issued on October 3, 2021.

"INOVIO remains steadfast in its mission to fight COVID-19 through the development of INO-4800, which is designed to serve the needs of those in India and beyond, as both a primary series and a booster vaccine."

INOVIO has partnered with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to conduct the INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa.

This news builds on INOVIO's previously announced authorization to proceed in China with two Advaccine-sponsored clinical trials investigating heterologous boost combinations' safety, tolerability, and immunogenicity with INO-4800.

The INO-4800 DNA vaccine candidate is composed of a precisely designed DNA plasmid injected intradermally followed by electroporation using a proprietary smart device, which delivers the DNA plasmid directly into cells in the body and is intended to produce a well-tolerated immune response.

As one of the only nucleic-acid-based vaccines stable at room temperature for more than a year, INO-4800 has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage.

Furthermore, INO-4800 is anticipated to be well-positioned for a primary series immunization as well as a booster, says the company.