On April 7th, Inovio Pharmaceuticals announced that the US Food and Drug Administration had accepted its application for clinical trial of COVID-19 candidate DNA vaccine INO-4800. This is the third COVID-19 vaccine to enter the clinical trial stage in the world, and it is also the first DNA vaccine candidate.
The company plans to start a 1 phase clinical trial this week, and the first volunteer plans to be vaccinated in April. In the 1 phase of the INO-4800 research, 40 healthy adult volunteers will be recruited at the perelman Medical College of the University of Pennsylvania and the Drug Research Center in Kansas City, Missouri. Each participant will receive two doses of INO-4800 within four weeks. The initial immune response and safety data of this study are expected to be released at the end of this summer.
The screening of potential participants has started in these two places, and the research data of INO-4800 was delivered to the local area last week.
The preclinical study of INO-4800 shows that the vaccine has achieved satisfactory immune response results in various animal experiments. These data have been shared with global regulators and submitted as part of IND. Other preclinical trials, including challenging studies, will continue to be conducted simultaneously with the 1 phase clinical trial.
Up to now, the preclinical research results of INOVIO's COVID-19 vaccine are consistent with those of INOVIO's Middle East respiratory syndrome vaccine research completed in 1 period. MERS is also caused by coronavirus. In the study of MERS vaccine, INOVIO's DNA vaccine produced good tolerance in 95% of the subjects, and induced a high level of antibody response, and at the same time produced a wide range of T cell responses in nearly 90% of the subjects. Within 60 weeks after administration, the DNA vaccine used in this experiment maintained a lasting antibody response in the subjects.
INO-4800 is the first candidate drug for COVID-19 DNA vaccine to enter the clinical trial stage in the world. Prior to this, two other vaccines entered the clinical trial stage, namely the adenovirus vector vaccine jointly developed by the scientific team of the Academy of Military Sciences of the Chinese People's Liberation Army and Kangxinuo Company, and the mRNA vaccine developed by the biotechnology company Moderna Therapeutics funded by the National Institutes of Health.
After the outbreak of COVID-19 virus, Inovio Pharmaceuticals obtained $5 million from the Bill and Melinda Gates Foundation to accelerate the testing and pilot scale expansion of CellereTra3PSP. CELLECTRA 3PSP is an intelligent device independently developed by INOVIO company, which is used for subcutaneous delivery of vaccine INO-4800.
In addition, INO-4800 also received financial support of up to $9 million from the Epidemic Prevention Innovation Alliance. Inovio Pharmaceuticals is also one of the three partners announced by the Epidemic Prevention Innovation Alliance. The company's main task is to use its DNA drug platform to quickly develop new epidemic virus vaccines. At present, the company plans to speed up the test and pilot scale-up of CELLECTRA 3PSP equipment, and strive to realize the large-scale production of INO-4800 by the end of 2020.
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