Clinical Trials

Date: 2017-05-24

Type of information: Presentation of results at a congress

phase: 1

Announcement: presentation of results at the 2017 HVTN Spring Full Group Meeting

Company: Inovio Pharmaceuticals (USA - PA)

Product: Pennvax®-GP

Action mechanism: vaccine. Pennvax®-GP is a developmental vaccine to prevent and treat HIV strains primarily present in Africa, Asia, Europe, and North America. This multi-subtype vaccine is based on optimized synthetic immunogens targeting two env antigens as well as gag and pol antigens—providing global coverage against HIV-1 subtypes. It is delivered using Inovio’s Cellectra® electroporation device. Development of the Pennvax®-GP vaccine has been funded through a $25 million NIAID contract awarded to Inovio and its collaborators.

Disease: HIV infection

Therapeutic area: Infectious diseases

Country:

Trial details:

Latest news:

• • On May 24, 2017, Inovio Pharmaceuticals announced that its HIV vaccine, PENNVAX®-GP, produced amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. These preliminary results are from a study supported by the HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in collaboration with Inovio. The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal (ID) or intramuscular (IM) administration in combination with a DNA encoded immune activator, IL-12 (INO-9012). Overall, 71 of 76 (93%) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens (env A, env C, gag, or pol).
• Similarly, 62 of 66 (94%) evaluated participants demonstrated an env specific antibody response. None of the placebo recipients (0 of 9; 0%) demonstrated either a cellular or an antibody response in the study. Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 (96%) participants demonstrated a cellular response and 27 of 28 (96%) demonstrated an HIV env specific antibody response.
• Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 (100%) demonstrated a cellular response and 19 of 21 (90%) demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration.
• This data was presented at a plenary session at the 2017 HVTN Spring Full Group Meeting on May 23 in Washington, D.C. by the Protocol Co-Chair of the HVTN 098 study, Dr. Stephen De Rosa, Research Associate Professor, Laboratory Medicine at the University of Washington and Fred Hutchinson Cancer Research Center. The HVTN 098 trial was the first clinical study of PENNVAX-GP. The randomized, placebo-controlled multi-center study enrolled 94 subjects (85 vaccine and 9 placebo) to characterize and optimize PENNVAX-GP immunization regimens delivered through vaccinations using either intramuscular or intradermal delivery.
• • On September 8, 2015, Inovio Pharmaceuticals announced that the first patient has been dosed in a phase I trial to evaluate safety and tolerability of Pennvax®-GP, Inovio’s “universal” DNA vaccine for HIV. This human study is in collaboration with the HIV Vaccine Trials Network (HVTN). The trial will measure immune responses following administration of the vaccine in four groups of healthy subjects receiving the vaccine with and without an immune activator (IL-12) and delivered into muscle or skin using Inovio’s Cellectra® delivery technology. This study is conducted by the HVTN and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
• Results from the previous Pennvax phase I trial, HVTN 080, were published in Journal of Infectious Diseases in 2013 and showed that 89% (24/27) of subjects developed a robust CD4 or CD8 response. In addition, immune response rates remained strong and persistent six months after vaccination. Achieving a robust CD8 T-cell response in a significant number of patients had been a previous barrier for HIV researchers. Importantly, PENNVAX was able to generate CD8 T-cell responses with significant magnitude as measured by the HVTN core laboratory at the Fred Hutchinson Cancer Center, whose assays have been standardized to evaluate several different vaccine delivery technologies. Notably, CD4 and CD8 T-cells are both important in cellular immunity, however, CD8 T-cells are considered especially integral to fighting cancers and chronic infectious diseases. The Pennvax®-GP product was developed as a universal HIV vaccine to expand and improve the coverage of the earlier version of Pennvax against multiple divergent virus strains and clades across the globe.

Is general: Yes