Our goal is to initiate a phase I clinical trial for this DNA vaccine in Europe before year end. Our clinical team is fulfilling information requests from the US Food & Drug Administration (FDA) relating to our previously-filed IND and aims to initiate a US phase I clinical trial in Q1 2010. These studies will focus on safety and immunogenicity.
Universal Influenza DNA Vaccine
Subsequent to the quarter end, Inovio reported multiple sets of data relating to the testing of its universal influenza vaccine, which was designed in 2006/2007 to provide broad cross-strain protection against existing and new, unmatched (hence, unknown) seasonal and pandemic-potential influenza strains.
Multiple studies in pig model showed the ability 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 mouse model also showed the ability 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 are challenged with another currently circulating swine influenza A/H1N1 virus.
PENNVAXTM HIV DNA Vaccines
The 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 expects to report results of this study by year end.
An IND has been submitted for a second prophylactic trial, using electroporation to deliver PENNVAX?„?-B. The company expects that the HVTN will initiate this phase I trial before year end.
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.
Other Vaccine Research & Development
Subsequent to the quarter end, Inovio announced that its first SynCon?„? dengue virus DNA vaccine induced neutralizing antibody responses against all four distinct serotypes of dengue viruses that are transmitted to humans by mosquitoes. Currently there is no commercially available vaccine or antiviral drug against dengue virus infections. The results were published in Vaccine, July 3, 2009, in a paper entitled, Development of a novel DNA SynCon tetravalent dengue vaccine that elicits immune responses against four serotypes. This accomplishment highlighted the ability of Inovio ™s SynCon?„? vaccine design approach to create DNA vaccines with universal protective capability.
VGX-1027
The company ™s small molecule drug for rheumatoid arthritis completed a single ascending dose study in 2008 and a multiple ascending dose study in Q1 2009, marking the end of the phase 1 trial. Inovio expects to license the drug to a pharmaceutical company for a milestone-based licensing fee and royalty as a percentage of sales.
Partner Programs
PSMA Prostate Cancer DNA Vaccine
New data generated by the University of Southampton and Institute of Cancer Research in the U.K. were published in the medical journal, Human Gene Therapy, July 20, 2009, in a paper entitled, DNA vaccination with electroporation induces increased antibody responses in patients with prostate cancer. This phase I proof-of-concept study of a prostate cancer vaccine generated what Inovio believes to be the first demonstration of a significantly increased and persistent level of antibody response to a helper sequence of a DNA vaccine generated by the DNA vaccine delivered using electroporation. Analyses of T-cell immune responses to the PSMA antigen are ongoing.
ChronVac?® Hepatitis C Virus DNA Vaccine
Enrollment has been completed in this phase I proof-of-concept study of Tripep ™s hepatitis C virus vaccine. Inovio expects to report additional interim results before year end.
hTERT Cancer Vaccine
Merck continues to enroll patients in its phase I clinical study of an hTERT DNA vaccine using Inovio ™s electroporation delivery technology against breast, lung, and prostate cancers.
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