SynCon® vaccine data
Demonstrating broad immune response
Inovio is achieving a growing body of human data from multiple clinical studies that is demonstrating the broad immune stimulating characteristics of our SynCon® vaccine platform and providing evidence of the potential to provide preventive and/or therapeutic capabilities in different disease areas:
- Unprecedented antigen-specific, dose-related T-cell immune responses reported in cancer and HIV:
In a Phase I study of VGX-3100, this therapeutic vaccine for cervical dysplasia drove robust immune responses to antigens from high risk types of human papillomavirus (HPV) infection and these immune responses displayed a powerful killing effect on cells changed by HPV into precancerous dysplasias. 78% of patients showed T-cell responses in the validated ELISpot assay (83%, or 5 of 6 patients, in the highest dose group). Further tests measured the ability of CD8+ T-cells from vaccinated patients to kill cells displaying HPV antigens on their surface: 91% of patients who developed T-cell responses showed the presence of CD8+ "killer T-cells.” These killer T-cells are believed to be critical for the treatment of cervical dysplasia and ultimately cancer caused by HPV as well as for potentially treating other cancers and infectious diseases. These results were published in the peer-reviewed journal, Science-Translational Medicine, in an article entitled, "Immunotherapy against HPV 16/18 generates potent Th1 and cytotoxic cellular immune responses."
- Phase I study of PENNVAX®-B , our vaccine for clade B HIV (prevalent in North America and Europe). In this study of uninfected subjects, T-cell responses (CD4+, CD8+, or both) were observed to at least one of the vaccine antigens in 88.9% (24 of 27) of evaluated subjects after three vaccinations with PENNVAX®-B and our IL-12 cytokine gene adjuvant followed by electroporation. Data from this study was published in the Journal of Infectious Diseases in the article, "Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid IL-12 and impact of intramuscular electroporation for delivery."
- Cross-strain protective antibodies, a critical step in the development of a universal influenza vaccine:
- SynCon® avian influenza vaccine generated HAI titers in human subjects against six different, unmatched strains of H5N1. The vaccine candidate generated strong binding antibodies in 96% of subjects and strong CTL responses to at least one of the vaccine components in 72% of subjects.
- Phase 1 clinical data from our H1N1 influenza synthetic vaccine study demonstrated protective HAI titers of 1:40 or higher against each of the nine, unmatched strains of H1N1 in a significant percentage of immunized trial subjects including the 1918 H1N1 pandemic and the 2009 swine flu. The vaccine candidate also generated protective antibody levels comparable to a current FDA-approved seasonal influenza vaccine against a currently circulating influenza strain.
- Synthetic vaccines for influenza Type A H3N2 and Type B achieved protective antibody responses against multiple unmatched strains in immunized animals, further validating potential to create a universal influenza vaccine.
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