Inovio expects FDA decision on COVID-19 vaccine trial start this month - Metro US

Inovio expects FDA decision on COVID-19 vaccine trial start this month

FILE PHOTO: A woman holds a small bottle labeled with a 'Vaccine COVID-19' sticker and a medical syringe in this illustration

(Reuters) – Inovio Pharmaceuticals Inc on Monday said it expects the U.S. Food and Drug Administration to decide this month whether to allow an advanced trial of the company’s experimental COVID-19 vaccine to move forward.

The regulatory agency in September placed a hold on the mid- to late-stage trial, citing the need for more information on the device used to inject the vaccine. Inovio said it provided responses to the FDA’s questions in October.

Shares of Inovio, which closed down 19% at $8.50, were up 4% after hours.

Inovio’s vaccine, known as INO-4800, was designed using the company’s novel DNA medicine platform. It is administered through a device called Cellectra, which sends out an electrical pulse to open pores in a cell so DNA molecules can enter.

Inovio in June announced positive results from an initial trial of its vaccine in volunteers, but the company has lagged behind others in the race to develop vaccines against the new coronavirus.

Pfizer Inc and German partner BioNTech SE on Monday announced the first successful interim data from a large-scale COVID-19 vaccine trial and said they expected to seek U.S. emergency use authorization this month.

Inovio Chief Executive Joseph Kim called Pfizer’s trial data “great proof of concept” for the field and validation of vaccine work by Inovio and others.

It is going to take “muliple vaccines to help the world control this virus,” he said on a conference call.

The CEO said the planned vaccine trial will cost “several hundred million dollars,” and Inovio is confident that once the FDA lifts the clinical hold, it will be able to secure external funding.

Kim said Inovio’s vaccine could have an advantage in terms of storage. INO-4800 is stable at room temperature for more than a year, while the Pfizer/BioNTech vaccine, based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below.

(Reporting By Deena Beasley; Editing by Bill Berkrot)

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