Inovio Pharmaceuticals announced that the United States Food and Drug Administration had accepted the New Drug application for INO-4800, a vaccine that is designed to prevent COVID-19, clearing the way for Phase 1 clinical testing in healthy volunteers. The company administered the first dose on Monday.
Inovio Pharmaceuticals’ CEO, Dr. J. Joseph Kim said about the development, “This is a significant step forward in the global fight against COVID-19. Without a new, safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods.”
In a statement, Kim lauded the commitment of his team saying, “Our dedicated team of staff, partners and funders, have been mobilized since the genetic sequence of the virus became available in early January and continues to work around the clock to ensure that we are rapidly advancing INO-4800 through this Phase 1 study towards planned efficacy trials.”
The vaccine is backed by the Bill and Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI), among others.
Why It Matters
The Phase 1 study of INO-4800 will enroll 40 healthy volunteers in Philadelphia and Kansas City, Missouri. The screening of participants has already commenced.
Each participant will receive two doses of INO-4800 four weeks apart, and initial immune response and safety data are expected in late summer.
The biotech company has already manufactured thousands of doses of INO-4800 to support both Phase 1 and Phase 2 trials and is scaling up manufacturing of INO-4800. The company plans to have one million doses of the vaccine available by year-end for trials as well as emergency use, subject to regulatory guidance and funding.
This is not Inovio Pharmaceuticals’ first foray into DNA vaccines, the company has also completed the phase 1 study for the Middle East Respiratory Syndrome (MERS), also caused by a coronavirus.
Massachusetts-based biotech peer Moderna Inc. (NASDAQ: MRNA) is also working on a COVID-19 vaccine, which could enter Phase 2 trials in spring or early summer. Johnson & Johnson (NYSE: JNJ) are also developing a vaccine.
Inovio Pharmaceuticals shares traded 3.32% higher at $8.72 in the after-hours session on Monday. The shares had closed the regular session 9.04% higher at $8.44.
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