Plymouth Meeting-based Inovio Waiting for FDA Approval to Start COVID-19 Vaccine Trials

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Plymouth Meeting-based Inovio Pharmaceuticals is waiting for approval from the FDA to start the next stage of trials for its COVID-19 vaccine candidate. Image via Philadelphia Magazine.

Plymouth Meeting-based Inovio Pharmaceuticals is waiting for approval from the FDA to start the next stage of trials for its COVID-19 vaccine candidate, INO-4800, writes Queen Muse for the Philadelphia Magazine.

In April, the biotech company quickly became one of the frontrunners among organizations working on a COVID-19 vaccine after its candidate entered the human testing stage.

Two months later, the company released limited data from its Phase I trial showing that INO-4800 had successfully triggered an immune response in all but two of 36 trial participants with no adverse effects.

In early September, the company signed a letter of intent with Thermo Fisher Scientific to manufacture its DNA vaccine candidate. It also set the goal of having 100 million doses manufactured in 2021.

However, Inovio’s efforts stalled later that month when the FDA put a partial clinical hold on its planned Phase II/III trial before it began.

The hold was instituted due to the agency having “additional questions” about the company’s proposed trial, and “not due to the occurrence of any adverse events” from its Phase I trial, said Inovio spokesperson.

Read more about Inovio Pharmaceuticals at the Philadelphia Magazine by clicking here.

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