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Inovio Pharmaceuticals Inc expects to begin a late-stage U.S. examine of its experimental COVID-19
vaccine candidate within the second quarter of 2021, the drug developer’s chief govt officer stated on Monday.
Inovio’s vaccine, INO-4800, is being examined in two trials – a mid-stage examine in China in partnership with Advaccine Biopharmaceuticals Suzhou Co Ltd and a mid-to-late stage trial within the United States.
The U.S. Food and Drug Administration had put the Phase III portion of the examine on maintain in September, because the company sought extra info, together with particulars of a supply gadget used to inject INO-4800 into pores and skin cells.
Inovio expects to reply all regulatory questions raised by the FDA relating to its vaccine supply system by the second quarter, Dr. Joseph Kim, the corporate’s chief govt officer, informed 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 stated.
The regulatory delay has resulted in Inovio lagging behind different builders within the race to develop a vaccine, as photographs from Pfizer-BioNTech and Moderna have already gained authorization for emergency use within the United States.
On Monday, Inovio additionally entered a licensing settlement with Advaccine for manufacturing and promoting INO-4800 in China.
Under the deal, Advaccine will get unique rights to Inovio’s vaccine candidate in China, and Inovio will obtain an upfront cost of $3 million, an combination of $108 million upon reaching milestones, and also will be entitled to gross sales royalty.
Advaccine is scaling up its manufacturing functionality and expects to provide 100 million doses of the vaccine this yr for China, Inovio stated.
Shares of Pennsylvania-based Inovio rose 6% to $9.43 on Monday afternoon.
Disclaimer: This submit has been auto-published from an company feed with none modifications to the textual content and has not been reviewed by an editor
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