Inovio Expands Enrollment In Ebola Vaccine Phase I Study

Late last week, Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced that it is expanding the enrollment in a phase I study evaluating its Ebola DNA vaccine, INO-4212. The company is enrolling 125 patients in the second stage of a phase I study on INO-4212 and will evaluate immune response characteristics generated with fewer intradermal administrations, lower doses, and with or without its DNA-based IL-12 immune activator.

The study will also help characterize and identify in humans the most optimal immunization regimen using intradermal (skin) delivery of its preventive Ebola DNA vaccine.

The decision to expand study enrollment came after positive initial safety and immune response data was received from the first set of 75 healthy volunteers. The initial 75-patient stage of the study evaluated INO-4212 in muscle and skin in five study arms in two and three doses, one including Inovio’s DNA-based IL-12 immune activator.

Inovio plans to meet with regulators regarding the path forward for INO-4212 following the close of this study, which it anticipates early next year.

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We note that the company was awarded a $45 million grant by the Defense Advanced Research Projects Agency in 2015 to lead a collaborative team for the development of multiple treatment and prevention approaches against Ebola. The Inovio-led consortium is taking a multi-faceted approach to develop treatments for the prevention of Ebola.

And it’s not just Inovio taking action to curb this lethal disease in the absence of an approved vaccine or treatment. Companies like GlaxoSmithKline plc (NYSE:GSK) , Johnson & Johnson (NYSE:JNJ) and Merck & Co., Inc. (NYSE:MRK) among others are also developing Ebola vaccines.

In fact, Merck’s Ebola Zaire vaccine candidate known as V920 received Breakthrough Therapy status from the FDA while the European Medicines Agency provided the candidate PRIME (PRIority MEdicines) status last month.