BioPharma, Policy

Inovio shares sink after FDA places partial hold on Phase II/III Covid-19 vaccine study

The company emphasized that the partial hold was due to “additional questions” about the study, including the delivery device being used, and was not related to any adverse events. As such, the Phase I study of the vaccine, INO-4800, is proceeding.

By Alaric DeArment on September 28, 2020

One of the late-stage trials of a vaccine against the virus that causes Covid-19 has been placed on hold as the Food and Drug Administration has additional questions for the company developing it.

Plymouth Meeting, Pennsylvania-based Inovio Pharmaceuticals said Monday that the FDA had placed a partial clinical hold on the Phase II/III trial of INO-4800, its vaccine against the SARS-CoV-2 virus. The company said the agency had “additional” questions about its trial, including the delivery device it intends to use, the Cellectra 2000. It added that the hold is not related to any adverse events from the vaccine in the Phase I trial, which is ongoing.

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The Phase II/III study is not currently listed on ClinicalTrials.gov, but the company said on Sept. 8 that it planned to initiate it this month.

Nevertheless, shares of Inovio (Nasdaq: INO) fell sharply on the news and were down 30% or more on the Nasdaq after markets opened Monday.

Meanwhile, British drugmaker AstraZeneca resumed the trials of the vaccine it developed with the University of Oxford, AZD1222, in the U.K., following a hold placed on them by that country’s drug regulator, the Medicines and Healthcare products Regulatory Agency, after a participant suffered an adverse event.

However, a planned Phase III trial of AZD1222 in the U.S., posted on ClinicalTrials.gov last month, remains on hold, Department of Health and Human Services Secretary Alex Azar told CNBC last week. The entry on the website for the 30,000-participant study was posted on Aug. 18, but has not been updated since then.

Meanwhile, several other companies have already entered their vaccines against SARS-CoV-2 into late-stage development. These include Moderna, which is running a Phase III study of 30,000 participants of its messenger RNA vaccine, mRNA-1273, and the Phase III study of another mRNA-based vaccine, Pfizer and BioNTech’s BNT162b2. Johnson & Johnson announced last week the initiation of a late-stage trial of its vaccine, which is administered via a single shot, compared with the two shots needed for most Covid-19 vaccines.

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