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– Human Trials Planned for April; One Million Doses Expected by Year End
Minapim by Hernan Valenzuela: Inovio Pharmaceuticals, Inc. announced an accelerated timeline for developing its DNA vaccine INO-4800 to address COVID-19, the respiratory infection the World Health Organization (WHO) has designated a Public Health Emergency of International Concern of the highest level. According to WHO, approximately 131.570 cases have been reported globally with more than 4.937 deaths. (March 12/2020 at 17:35 PM – Source: cna.asia/covid19)
Dr. J. Joseph Kim, Inovio’s President & CEO, shared this accelerated timeline at the U.S. Coronavirus Task Force meeting at the White House on March 2. Dr. Kim said, “Inovio is the leader in coronavirus vaccine development and the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS). Using our modern DNA medicines platform, we designed our DNA vaccine INO-4800 in three hours after the publication of the genetic sequence of the novel coronavirus that causes COVID-19.”
Dr. Kim continued, “We immediately began preclinical testing and small-scale manufacture and have already shared robust preclinical data with our public and private partners. We plan to begin human clinical trials in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people. We plan on delivering one million doses by year end with existing resources and capacity. However, we will need additional resources to scale up to make enough doses to help protect Americans from COVID-19 as well as to lead global efforts to curtail this virus.”
Inovio’s COVID-19 DNA Vaccine Development Timeline
| December 31, 2019 | Inovio scientists learn about a novel coronavirus (SARS-CoV-2) which caused an outbreak of respiratory disease in Wuhan, China, now referred to as COVID-19 |
| January 10, 2020 | Chinese researchers share the genetic sequence of the novel coronavirus
Inovio designs DNA vaccine INO-4800 in three hours after INO-4800 was designed to precisely match the DNA sequence |
| January 10 to January 23, 2020 | Inovio scientists race to manufacture INO-4800 and begin preclinical testing |
| January 23, 2020 | Inovio receives a grant of up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to fund ongoing preclinical and initial clinical development of INO-4800 |
| January 23 to February 29, 2020 | Preclinical testing continues, with immune responses generated in animal models; human clinical trial designs developed |
| March 2020 | Ongoing preclinical studies; human clinical trial designs finalized; 3,000 human trial doses prepared for clinical trials in the U.S., China, and South Korea; large-scale manufacturing plans developed |
| April 2020 | Human clinical trials begin in 30 healthy volunteers in the U.S.
Human clinical trials to begin in China and South Korea |
| Fall 2020 | Human clinical trial results presented/published |
| End of 2020 | 1 million doses of INO-4800 COVID-19 DNA vaccine produced for further trials or emergency use |
Source: Inovio
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