Inovio Kicks Off 2nd Stage of Phase 1 Human Trials of Ebola DNA Vaccine; J. Joseph Kim Comments

Inovio Pharmaceuticals has begun to enroll 125 individuals for the second stage of the Phase 1 clinical trial of its Ebola DNA vaccine candidate in an effort to evaluate how the vaccine generates immune responses.

Inovio tested the INO-4212 vaccine in 75 healthy volunteers during the first clinical trial’s initial stage and found that 100 percent of 13 subjects in one study arm showed Ebola antigen-specific antibody responses after they received two intradermal doses of the experimental vaccine, Inovio said Thursday.

The company also found that 92 percent of 13 trial participants in another study arm showed antibody responses after two INO-4212 intramuscular immunizations were administered in combination with Inovio’s DNA-based IL-12 immune activator.

“Our goal now is to characterize the best immunization regimen and continue building the safety database required for regulatory approval,” said J. Joseph Kim, president and CEO of Inovio Pharmaceuticals.

“We plan to meet with regulators regarding a path forward following the close of this study early next year with results from 200 patients and positive preliminary pre-clinical data from several animal models, which we already have in hand.”

A consortium led by Inovio received $45 million in funds in 2015 to develop vaccines against Ebola virus under a Defense Advanced Research Projects Agency-funded initiative.

The DARPA-backed program supports Inovio’s development work on INO-4212, Ebola dMab product and a protein-based monoclonal antibody against Ebola virus in collaboration with AstraZeneca’s MedImmune subsidiary.