The biotechnology company Inovio, dedicated to the production of DNA drugs designed to treat and protect people from infectious diseases, cancer and those associated with HPV, announced this Monday that it received authorization from Invima of Colombia to carry out a clinical trial in the country as part of the phase 3 segment of the global phase 2/3 Innovate trial for its DNA vaccine candidate for Covid-19 (INOVIO INO-4800 Vaccine Trial for Efficacy).
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Inovio is working with its partner Advaccine Biopharmaceuticals Suzhou Co. (Advaccine) on Inovio’s Phase 3 segment in several countries, with a focus on Latin America, Asia and Africa. The company also recently announced that it has received regulatory clearance to conduct trials in Brazil, the Philippines and Mexico.
Innovate’s Phase 3 global segment 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 non-pregnant men and women , over 18 years. The endpoint of this trial is based on virologically confirmed COVID-19 cases..
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Inovio President and CEO Dr. J. Joseph Kim said: “Inovio is pleased to share the news of regulatory clearance to proceed with our phase 3 trial in Colombia. With covid-19 infection rates increasing in many areas and with still limited access to vaccines in many countries around the world. We thank the health authorities for supporting our efforts to make more vaccines available and accessible. If approved, the INO-4800 DNA vaccine candidate can further boost vaccination in Colombia and other countries, because it can serve as a first-line or booster vaccine, with an adequate thermostability profile and the ability to generate neutralizing antibodies and robust T-cell responses “.
Innovate’s Phase 3 segment builds on the Phase 2 segment, which took place in the United States. And it was funded by the Executive Office of the U.S. Department of Defense Joint Program 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. . Phase 2 data was released in May 2021 and INO-4800 was found to be well tolerated and immunogenic in people over 18 years of age in the trial.. In another previously disclosed study, using clinical samples, INO-4800 was also found to provide extensive cross-reactive immune responses, including neutralizing antibodies and robust T-cell responses, against variants of interest (alpha, beta, gamma and, in subsequent research , delta). Factors that could be critical to contain COVID-19 as it transitions from pandemic to endemic spread.
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Inovio also recently announced authorization to proceed in China with two clinical trials, sponsored by Advaccine, investigating the safety, tolerability and immunogenicity of heterologous booster combinations with INO-4800.