The FDA has placed Inovio’s lead therapy on clinical hold, halting any new work on the program and putting off a planned start to the Phase III work.
The hold freezes efforts on VGX-3100 as the agency looks for “additional data to support the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device,” says the biotech $INO.
Inovio said in a brief statement that it now expects to launch the Phase III work in the first half of 2017. Its shares dropped 16% on the news.
VGX-3100 is designed to prevent cancers spurred by HPV. It targets E6 and E7 proteins of HPV types 16 and 18 and intramuscular injections are followed by electroporation using the delivery device.
VGX-3100 is one of 14 projects underway at Inovio, but as CNBC reported in a brutal Q&A with CEO Joseph Kim, the company has been criticized for chasing after each new pandemic with a new vaccine program, all while going 37 years without an approval.
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