What happened
Shares of Inovio Pharmaceuticals (INO +0.88%) were rising 5.4% as of 12:06 p.m. EST on Wednesday. The gain came after the company provided its third-quarter update following the market close on Tuesday. Inovio's biggest news was that the U.S. Food and Drug Administration (FDA) has given the go-ahead for the initiation of a phase 3 study of COVID-19 vaccine INO-4800.
So what
Inovio's planned U.S. phase 3 study of INO-4800 had been held up due to the FDA's partial clinical hold. However, that hold has now been lifted after the agency reviewed additional non-clinical, clinical, and device information supplied by the company.
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The relatively modest jump for the biotech stock after this news, though, probably reflects the questions about funding for the U.S. late-stage study. The U.S. Department of Defense initially planned to fund the study but changed its mind in April of this year.
However, Inovio continues to make progress with testing its COVID-19 vaccine candidate in other countries thanks to a partnership with Advaccine Biopharmaceuticals Suzhou. The two companies are conducting phase 3 clinical studies of INO-4800 in several countries in South America, Asia, and Africa.
Now what
More potential catalysts should be on the way soon. Inovio and Regeneron are evaluating data from their phase 1/2 study of INO-5401 and INO-9012 in combination with Libtayo in treating newly diagnosed glioblastoma multiforme, an aggressive type of brain cancer. Overall survival data after 24 months will be presented later this month.
Inovio expects to present findings later this year from its late-stage study of VGX-3100 in treating cervical high-grade squamous intraepithelial lesions caused by HPV-16 and/or HPV-18. The company also plans to report interim efficacy data for its COVID-19 vaccine candidate in the first half of 2022.
