Inovio's HIV Vaccine Elicits High Response Rates In Phase 1 Trial

Following the results release of an early-stage study of Pennvax-GP, Inovio Pharmaceuticals Inc INO's HIV vaccine, H.C. Wainwright noted that the vaccine elicited high T-cell and antibody immune responses in healthy and uninfected adults.

The Trial

Analysts Raghuram Selvaraju and Yi Chen noted that a four-dose regiment of Pennavax-GP DNA vaccine, containing four HIV antigens, was administered at months 0,1,3 and 6 by intradermal or intramuscular administration, in combination with an immune activator, IL-12, dubbed INO-9012.

The analysts noted that the goal of development is to attain long-term HIV remission in the absence of antiviral drugs.

The study plan, according to the analysts, includes a two-step clinical study in HIV-positive subjects to assess PENNVAX-GP with INO-9012 alone and with the addition of a PD-1 checkpoint inhibitor.

"The study is designed to test whether enhancing anti-HIV specific CD8 killer T cell immune responses alone or in combination with other products can influence the size of the viral reservoir pool, potentially resulting in reducing or eradicating the virus," the analysts said.

The Results

Making note of the preliminary data, H.C. Wainwright said 71 of the 76 evaluable participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigen.

Additionally, the firm said 62 of the 66 evaluable participants showed an env specific antibody response, compared to none of the placebo recipients. "In our view, these early results are very encouraging but not surprising, as they are in line with results from the company's trials of other DNA vaccines, including Ebola, Zika and MERS," the firm added.

However, the firm believes further studies need to be conducted to find whether Pennvax-GP can safely and effectively prevent HIV infection.

Q2: Phase 3 Study Of HPV-Related Vulvar Lesions

Meanwhile, H.C. Wainwright said the Phase 3 trial of VGX-3100 could start this quarter after having previously submitted a complete response to the FDA. If the FDA finds the resubmitted data satisfactory to lift the clinical hold, the firm expects Inovio to start the Phase 3 pivotal study of VGX-3100 for the treatment of HPV-16/18-related high grade cervical dysplasia in the current quarter.

The firm is of the view that the pivotal study would enroll approximately 400 subjects and to complete in roughly two years. VGX-3100, the firm noted, would be the first candidate within the company's extensive pipeline to enter a pivotal study.

As such, the firm reiterated its Buy rating and $13 price target on the shares of Inovio Pharma.

At the time of writing, shares of Inovio Pharma were down 8.81 percent at $7.92 after jumping roughly 22 percent on Wednesday in reaction to the results of the study.