Biotech firm Inovio Pharmaceuticals Inc. (NASDAQ: INO) announced Monday morning that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for INO-4800, a DNA vaccine candidate to prevent COVID-19 infection. Inovio will begin Phase 1 clinical testing Monday, using up to 40 healthy adult volunteers in Philadelphia and Kansas City.
Each volunteer will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer. Other preclinical trials, including challenge studies, will continue in parallel with the Phase 1 clinical trial, the company said.
Preclinical results for Inovio’s COVID-19 vaccine have been consistent with the company’s completed Phase 1 vaccine study for Middle East Respiratory Syndrome (MERS), also caused by a coronavirus, the company said. Durable antibody responses to its DNA vaccine (INO-4700) used in that trial were maintained through 60 weeks following dosing.
The Coalition for Epidemic Preparedness Innovations (CEPI), provided $58 million in funding for Inovio’s MERS vaccine, and the international organization announced in late January that it would support the company’s development efforts against COVID-19. The group is also funding an mRNA vaccine being developed by a partnership between Moderna Inc. (NASDAQ: MRNA) and the National Institute of Allergy and Infectious Diseases. Johnson & Johnson (NYSE: JNJ) is also working on a coronavirus vaccine with support from the U.S. Biomedical Advanced Research and Development Authority.
Since receiving funding, Inovio has manufactured thousands of doses of INO-4800 to support ongoing and planned clinical trials. The company also plans to have a million doses of the vaccine available by year-end for additional trials and emergency use, pending appropriate regulatory guidance and funding.
Richard Hatchett, CEO of CEPI, commented:
We are pleased to see the rapid advancement of [Inovio’s] vaccine candidate into clinical safety testing. Producing a COVID-19 vaccine within the next 12 to 18 months is not only a scientific challenge; it will also require new levels of collaboration and investment across industry and government. There is still a long road ahead before we have a safe, effective, and globally accessible vaccine ready for broader use, but today we have reached an important milestone on that journey.
Between January 1 and March 11, Inovio issued more than 43 million new shares to raise $208 million in an at-the-market (ATM) stock offering.
Inovio stock traded up about 4.2% shortly after the market opened on Monday, at $8.08 in a 52-week range of $1.92 to $19.36. The consensus price target on the stock is $10.43.
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