Inovio has worked through the FDA’s questions about its COVID-19 vaccine delivery device, leading the agency to lift a partial clinical hold and clear the biotech to start enrolling subjects in the U.S.
Pennsylvania-based Inovio got the green light after sharing data on Cellectra 2000, a handheld device that uses a brief electrical pulse to allow plasmids to enter cells through temporary pores. An earlier version of the device received a CE mark clearing it for use in Europe several years ago, but the FDA had questions that Inovio failed to address in its original submission.
Inovio provided additional nonclinical, clinical and device information to resolve the FDA’s queries, clearing it to enroll U.S. subjects in its phase 3 program. The impact of the clearance on enrollment is expected to be minimal, though, with Inovio focusing on ex-U.S. territories.
“We really are not changing our strategy that much. What the clinical hold lift and actual phase 3 authorization to proceed from the FDA means is we can now add the U.S. participants into this global trial. And we look forward to adding U.S. participants based on feasibility and availability of those participants,” Inovio CEO Joseph Kim said on a conference call with investors.
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Kim’s comment about “feasibility and availability” points to the difficulties Inovio is likely to face as it tries to enroll subjects in the U.S. With proven, highly effective COVID-19 vaccines widely available in the U.S. for months, it is hard to see how studies of any new candidates can work outside of booster settings in the country or in the rest of the Western world.
Having ceded a huge head start to rival vaccine developers in the U.S., Inovio is focused on the large numbers of people who remain unvaccinated in other parts of the world. Kim cited India, Thailand, Brazil, Colombia, Mexico and the Philippines as examples of countries in which Inovio has received authorizations to study its vaccine in populations that lack ready access to other products and suffer enough COVID-19 cases to demonstrate efficacy.