On April 7, Inovio Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted an application for a new clinical trial (IND) for the new coronavirus candidate DNA vaccine, INO-4800. This is the third new coronavaccine in the world to enter clinical trials and the first DNA candidate.
(Original title: First new coronavirus DNA candidate vaccine will enter clinical trials, FDA accepts application)
Journalist, Bao Yu
The company plans to launch Phase 1 clinical trial this week, with the first volunteer scheduled to be vaccinated in April. The 1st INO-4800 study will recruit 40 healthy adult volunteers from the Perelman School of Medicine at the University of Pennsylvania and the Center for Drug Research in Kansas City, Missouri, each of whom will receive two doses of INO-4800 over a four-week period, and initial immune response and safety data for the study are expected to be released by the end of the summer.
Screening for potential participants has been initiated in both places, and last week the INO-4800 study materialwas was delivered locally.
Preclinical studies of INO-4800 have shown that the vaccine has achieved satisfactory immune response results in trials targeting a wide range of animals, and these data have been shared with regulators around the world and submitted as part of IND. Other preclinical trials, including challenging studies, will continue to be conducted in parallel with Phase 1 clinical trials.
To date, the preclinical findings of INOVIO’s new coronary vaccine are consistent with the results of the Phase 1 Middle East Respiratory Syndrome (MERS) vaccine completed by INOVIO, which is also caused by coronaviruses, and in MERS vaccine studies, INOVIO’s DNA vaccine produced good tolerance in 95% of subjects and induced high levels of antibody response, while in nearly 90% of the study participants produced a wide range of T-cell reactions. Within 60 weeks of administration, the DNA vaccine (INO-4700) used in the trial maintained a long-lasting antibody response in the subjects.
INO-4800 is the world’s first new coronavirus DNA candidate vaccine in clinical trials. Prior to that, two other vaccines had entered clinical trials, namely the adenovirus vector vaccine developed jointly by the scientific team of the Chinese People’s Liberation Army Academy of Military Sciences and Concino, and the mRNA vaccine developed by ModernA Therapeutics, a biotech company funded by the National Institutes of Health (NIH).
In the wake of the new corona outbreak, Inovio Pharmaceuticals received $5 million from the Bill and Melinda Gates Foundation to speed up CELLECTRA 3PSP testing and pilot amplification. CELLECTRA 3PSP is a smart device developed by INOVIO for subcutaneous delivery of the vaccine INO-4800.
In addition, INO-4800 has received up to $9 million in funding from the Alliance for Innovation in Epidemic Prevention (CEPI). Inovio Pharmaceuticals is also one of three partners announced by the Alliance for Epidemiological Prevention and Innovation. The company’s main task is to use its DNA drug platform to rapidly develop new pandemic virus vaccines. The company now intends to accelerate the testing and pilot amplification of CELLECTRA 3PSP equipment, with a view to achieving mass production of the INO-4800 by the end of 2020.