On April 7, Inovio Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s application for an Investigational New Drug (IND) for its new coronavirus DNA vaccine candidate, INO-4800, in clinical trials. This is the third neocoronavirus vaccine in the world to enter clinical trials and the first DNA vaccine candidate. The company plans to initiate the Phase 1 clinical trial this week, with the first volunteer scheduled to receive the vaccine in April. 40 healthy adult volunteers will be recruited for the Phase 1 INO-4800 study at the Perelman School of Medicine at the University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City, Missouri, and each participant will receive two doses of INO-4800 administered four weeks apart, with initial immune response and safety data expected late this summer. safety data from this study are expected to be published late this summer. Screening of potential participants has been initiated at both sites, and study supplies of INO-4800 were shipped there last week. Preclinical studies of INO-4800 have demonstrated satisfactory immune response results for the vaccine in trials against a wide range of animals, and these data have been shared with global regulatory agencies and submitted as part of the IND. Additional preclinical trials, including challenge studies, will continue to be conducted concurrently with the Phase 1 clinical trial. To date, the results of INOVIO’s preclinical studies of the new crown vaccine have been consistent with the results of INOVIO’s completed Phase 1 Middle East Respiratory Syndrome (MERS) vaccine study, which is also caused by a coronavirus, in which INOVIO’s DNA vaccine was well tolerated and induced high levels of antibody in 95 percent of the subjects in the MERS vaccine study responses, while generating broad T-cell responses in nearly 90% of study participants. The DNA vaccine (INO-4700) used in this trial maintained a durable antibody response in subjects for 60 weeks after dosing. INO-4800 is the world’s first new coronavirus DNA vaccine candidate to enter clinical trials. Previously, two other vaccines entered clinical trials: an adenovirus vector vaccine developed by a scientific team at the Military Academy of Sciences of the People’s Liberation Army (PLA) in conjunction with Concinol, and an mRNA vaccine developed by Moderna Therapeutics, a biotech company funded by the U.S. National Institutes of Health (NIH). Following the outbreak of New Crown, Inovio Pharmaceuticals received a$5 million grant from the Bill &Melinda Gates Foundation to accelerate testing and pilot scale-up of CELLECTRA 3PSP, an a smart device developed in-house by Inovio for the subcutaneous delivery of the vaccine INO-4800. In addition, INO-4800 has received up to$9 million in funding from the Consortium for Epidemic Preparedness Innovation (CEPI).Inovio Pharmaceuticals is also one of the three partners announced by the CEPI. The company’s primary mission is to leverage its DNA drug platform to fast-track efforts in novel pandemic virus vaccine development. The company now intends to accelerate testing and pilot scale-up of the CELLECTRA 3PSP device, aiming to achieve large-scale production of INO-4800 by the end of 2020. Content source: Surfing News