Inovio Pharmaceuticals Inc expects to start a late-stage U.S. study of its experimental COVID-19 vaccine candidate in the second quarter of 2021, the drug developer’s chief executive officer said on Monday.
Inovio’s vaccine, INO-4800, is being tested in two trials – a mid-stage study in China in partnership with Advaccine Biopharmaceuticals Suzhou Co Ltd and a mid-to-late stage trial in the United States.
The U.S. Food and Drug Administration had put the Phase III portion of the study on hold in September, as the agency sought more information, including details of a delivery device used to inject INO-4800 into skin cells.
Inovio expects to answer all regulatory questions raised by the FDA regarding its vaccine delivery system by the second quarter, Dr. Joseph Kim, the company’s chief executive officer, told Reuters.
“We expect to complete mid-stage trials in March and project we will be able to start late-stage trials in second quarter of this year,” Dr. Kim said.
The regulatory delay has resulted in Inovio lagging behind other developers in the race to develop a vaccine, as shots from Pfizer-BioNTech and Moderna have already gained authorization for emergency use in the United States.
On Monday, Inovio also entered a licensing agreement with Advaccine for manufacturing and selling INO-4800 in China.
Under the deal, Advaccine will get exclusive rights to Inovio’s vaccine candidate in China, and Inovio will receive an upfront payment of $3 million, an aggregate of $108 million upon achieving milestones, and will also be entitled to sales royalty.
Advaccine is scaling up its manufacturing capability and expects to produce 100 million doses of the vaccine this year for China, Inovio said.
Shares of Pennsylvania-based Inovio rose 6% to $9.43 on Monday afternoon.
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