Vaccine Program Accomplishments, Status & Milestones
VGX-3100 Therapeutic Cervical Cancer DNA VaccineInovio announced on October 5th significant antibody and T-cell responses from the first of three dose groups being evaluated in this phase I clinical trial. These results were significant in providing the first indication of the potential for Inovio ™s DNA vaccine platform to rival levels of immune responses generated by any DNA vaccine technology. The company currently plans to report interim data relating to safety and levels of immune responses (immunogenicity) from the second and third dose groups in the first half of 2010. In addition, Inovio currently plans to initiate a Phase II trial in late 2010.
VGX-3400 Avian Influenza (H5N1) DNA VaccineOur clinical team is fulfilling information requests from the US Food & Drug Administration (FDA) relating to our previously-filed investigational new drug application (IND) and currently plans to initiate a US phase I clinical trial in Q1 2010. These studies are expected to focus on safety and immunogenicity.
Universal Influenza DNA VaccineInovio reported multiple sets of data from its universal influenza vaccine, which was designed in 2006/2007, indicating its potential to provide broad cross-strain protection against existing and newly emergent, unknown seasonal and pandemic-potential influenza strains.
Multiple studies in a pig model showed the potential of Inovio ™s universal DNA vaccines to induce levels of hemagglutination inhibition (HI) titers against multiple strains of H1N1 influenza, including currently circulating strains of swine-origin influenza. The titer levels achieved were above the protection threshold considered to be protective against influenza infection in 100% of the animals tested.
Studies in a mouse model showed the potential of Inovio ™s universal DNA vaccines to provide 100% protection in a lethal challenge study against an unmatched H1N1 virus that caused the 1918 Spanish flu. In a separate study, the vaccinated mice recovered from virus infection-induced morbidity significantly faster compared to the non-immunized control mice when the mice were challenged with another currently circulating swine influenza A/H1N1 virus.
A combination of Inovio ™s synthetic consensus (SynConTM) H1N1 influenza vaccine candidates achieved protective antibody responses against the novel pandemic influenza A/H1N1 (2009) in 100% of tested ferrets. The ferret model is widely considered to be the most representative of human influenza; achieving in ferrets a level of antibody titers commonly associated with protection in humans is a critical milestone in influenza vaccine development.
PENNVAXTM HIV DNA VaccinesThe company ™s partner, HIV Vaccines Trial Network (HVTN), completed enrollment of 120 subjects in its phase I clinical study of Inovio ™s PENNVAXTM-B preventive HIV vaccine (against HIV clade B, the prevalent HIV strain in North America and western Europe) without electroporation. The company currently expects to report results of this study by year end.
On October 15th, Inovio announced the initiation of a phase I clinical study of Inovio ™s PENNVAX?„?-B preventive DNA vaccine delivered using its proprietary electroporation technology. The multi-center study is being conducted at several HVTN clinical sites under a protocol designated HVTN-080. The study is enrolling healthy volunteers to assess safety of and levels of immune responses. The HVTN-080 follow-on study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), an NIH agency.
In a third trial, initiated in 2009, Inovio ™s collaborators at the University of Pennsylvania began enrolling adult HIV-infected patients undergoing therapy to assess the use of PENNVAX?„?-B DNA vaccine without electroporation in a therapeutic setting.
The company continues to advance its pre-clinical work on PENNVAX?„?-GP (against HIV clades A, C, and D, the prevalent strains in Africa and Asia) as a preventive HIV vaccine. This work is funded by a contract from the NIH ™s National Institute of Allergy and Infectious Diseases with a total potential value of about $23.5 million.
Source: Inovio Biomedical Corporation