Inovio Initiates Second Zika Vaccine Human Trial; Wainwright Reiterates Buy Rating

Inovio Pharmaceuticals Inc INO has initiated a second clinical trial for GLS-5700, its preventive Zika vaccine, in Puerto Rico, where the infections due to the Zika virus have been declared a public health emergency.

H.C. Wainwright’s Raghuram Selvaraju reiterated a Buy rating on the company, with a $17 price target.

“This trial follows the company’s first human trial of GLS-5700 in the U.S. and Canada, which was initiated in June 2016 and has fully enrolled and dosed 40 subjects,” Selvaraju mentioned.

Inovio expects the results from the first trial by end 2016, while the second trial is to be conducted on 160 healthy adults to evaluate tolerability, immunogenicity and safety. The results for the second trial are expected in 2017.

“Of note, Inovio and a U.S. government research institution are the only entities that have thus far initiated human clinical studies of Zika vaccines,” the analyst pointed out.

Other Pipeline Drugs

In addition, the Phase 3 trial for VGX-3100 are expected to start in late 2016. The FDA and the European Medicines Agency (EMA) have provided an “affirmative path” for VGX-3100 for the treatment of HPV-16/18-related high grade cervical dysplasia in a pivotal Phase 3 registration trial.

According to the H.C. Wainwright report, “Having completed the commercial device design and manufacturing process development, the company is now preparing to submit the final package to the FDA and expects the first dosing to start in 4Q16.”

The Phase 3 trial is expected to enroll about 350 patients across 150 sites across the world, while the efficacy endpoint would be similar to that used in the Phase 2 trial.

Selvaraju believes that this is positive news given that it has been 1.5 years since the Phase 2 trial, while no meaningful adverse events have so far been observed.

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