Inovio Pharmaceuticals, Inc.'s HIV Vaccine Elicits Nearly 100% Immune Response Rates in Clinical Study
May 24, 2017 at 08:00 am EDT
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Inovio Pharmaceuticals, Inc. 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. The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody (humoral) immune response as well as a T cell (cellular) immune response to both potentially prevent and treat HIV. 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 through 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 through both ID and IM administration of the vaccine although participants vaccinated through 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. Development of Inovio’s PENNVAX-GP immunotherapy, which widely targets multiple major clades of HIV providing global coverage has been funded through a $25 million NIAID contract previously awarded in 2009 to Inovio and its collaborators. In addition, Inovio and its collaborators were awarded an additional five-year $16 millionIntegrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant in 2015 from NIAID.
Inovio Pharmaceuticals, Inc. is a clinical-stage biotechnology company. The Company is focused on developing and commercializing deoxyribonucleic acid (DNA) medicines to help treat and protect people from diseases associated with human papillomavirus (HPV), cancer, and infectious diseases. Its DNA medicines pipeline include INO-3107 for HPV-related recurrent respiratory papillomatosis (RRP); INO-3112 for the treatment of HPV-related Oropharyngeal Squamous Cell Carcinoma, or OPSCC; VGX-3100 for the treatment of Anal or Perianal HSIL; INO-5401 for the treatment of Glioblastoma Multiforme (GBM), and INO-5401 for the Treatment of Glioblastoma Multiforme (GBM). Its lead candidate is INO-3107 for the treatment of RRP, a rare and debilitating disease of the respiratory tract caused by HPV infection. Its DNA medicines platform consists of DNA plasmids and its CELLECTRA devices, which are used to deliver the DNA plasmids into the cell. Its CELLECTRA device portfolio consists of two models.