Bill Gates-backed COVID-19 vaccine ugently rushed to human testing (science news).
Bill Gates-backed INOVIO Pharmaceuticals said yesterday that the U.S. Food and Drug Administration has now accepted the company’s DNA vaccine designed to prevent COVID-19 infection, paving the way for urgent Phase 1 priority clinical testing of their INO-4800 vaccine in volunteers beginning this week.
The first dosing of brave human volunteers went ahead on Monday 6th 2020, yesterday.
Preclinical results for the vaccine have, they say, proved consistent with their completed Phase 1 vaccine study for Middle East Respiratory Syndrome (aka MERS), also caused by a coronavirus, in which INOVIO’s DNA vaccine was well-tolerated and induced high levels of antibody responses in 95% of subjects, while also generating broad-based T cell responses in nearly 90% of study participants. Durable antibody responses to their INO-4700 DNA vaccine were maintained through 60 weeks following dosing.
In 10 weeks from funding by billionaire Bill Gates’ foundation, INOVIO has manufactured thousands of doses of INO-4800 to support their Phase 1 and planned Phase 2 clinical trials.
In parallel, INOVIO is working to scale up the manufacturing of INO-4800. INOVIO plans to have one million doses of the vaccine available by year-end for additional trials and emergency use, pending U.S. regulatory guidance and funding.
DNA medicines are composed of DNA plasmids, which are small circles of double-stranded DNA that are synthesised, or reorganised by a computer sequencing technology, designed to produce a specific immune response in the body.
INOVIO’s DNA medicines deliver plasmids directly into cells intramuscularly or intradermally using INOVIO’s hand-held smart device called a Cellectra. The device uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter, overcoming a major limitation of alternative DNA and mRNA approaches.
Once inside the cell, the plasmids are used by the cell’s own machinery to generate specific coded antigens, which then stimulate a vital potentially life-saving immune response.
