PLYMOUTH MEETING, Pa., Nov. 3, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases, and help treat cancer, and HPV-associated diseases, today announced that it has received authorization from India's Central Drugs Standard Control Organization (CDSCO)'s Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), in India for INO-4800, its DNA vaccine candidate for COVID-19. INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) to conduct the INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in India follows authorizations from health authorities in Brazil, Philippines, Mexico and Colombia.
The global Phase 3 segment of INNOVATE will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in a 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.
"As COVID-19 continues to threaten the health and safety of the global population, and many areas of the world are still awaiting sufficient access to safe and effective vaccines, 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. "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."
INNOVATE's Phase 3 segment builds upon the Phase 2 segment, which was conducted in the U.S. and funded by 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. Interim Phase 2 data from the ongoing study was disclosed in a pre-print in MedRxiv in May 2021 and showed INO-4800 to be well-tolerated and immunogenic in adults 18 and older. In another previously disclosed study using clinical samples, INO-4800 was also found to provide broad cross-reactive immune responses, including neutralizing antibodies and notable T cell responses, against variants of concern (alpha, beta, gamma and, in subsequent research, delta) – factors which could be critical in containing COVID-19 as it shifts from pandemic to endemic spread.
This news builds on INOVIO's previously announced authorization to proceed in China with two Advaccine-sponsored clinical trials investigating the safety, tolerability, and immunogenicity of heterologous boost combinations with INO-4800, as well as recent positive homologous boosting data for INO-4800, which was found to produce robust immune responses and was well-tolerated as both a two-dose series and as a homologous booster dose in all adults, including participants 65 years of age and older. Of note, a durable antibody response was observed six months following the second dose, and a homologous booster dose administered 6 to 10.5 months following the second dose also significantly increased antibody and T cell responses. INO-4800 was well-tolerated, with no treatment-related serious adverse events reported. Most adverse events were mild in severity and did not increase in frequency with age and subsequent dosing.
