Subsequent to year end, in January 2010 Inovio expanded its existing license agreement with the University of Pennsylvania, adding exclusive worldwide licenses for technology and intellectual property for novel DNA vaccines against pandemic influenza, Chikungunya, and foot-and-mouth disease. The amendment also encompasses new chemokine and cytokine molecular adjuvant technologies. The technology was developed in the University of Pennsylvania laboratory of Professor David B. Weiner, a pioneer in the field of DNA vaccines, and chairman of Inovio's scientific advisory board.
Clinical Development
VGX-3100 Therapeutic Cervical Cancer DNA Vaccine
In October we reported significant antigen-specific antibody and T-cell immune responses from the dose group of this phase I clinical study. Subsequent to year end, in February 2010 we reported higher dose-related immune responses from the second, intermediate dose group of this study. We expect to report the third and final dose group in Q3 2010.
VGX-3400 Avian Influenza (H5N1) DNA Vaccine
Subsequent to year end, in March 2010 our affiliate, VGX International, obtained Korean approval to initiate a phase I clinical study of this vaccine candidate in Korea. Inovio expects to obtain FDA approval to initiate a US phase I clinical trial in Q2 2010. These studies will focus on safety and immunogenicity (levels of vaccine-induced immune responses). In previously reported animal studies, this vaccine provided 100% protection of non-human primates against the H5N1 avian influenza virus, including multiple unmatched avian influenza strains.
Universal Influenza DNA Vaccine
During 2010, Inovio reported multiple sets of data relating to the testing of its H1N1 vaccine, which represents one component of its universal influenza vaccine concept (which Inovio expects to comprise H1, H2, H3 and H5 sub-types). Inovio's SynConTM influenza vaccines are designed to provide broad cross-strain protection against existing and newly emergent, unmatched seasonal and pandemic-potential influenza strains.
Inovio reported pre-clinical results from multiple studies, including protection of 100% of ferrets, considered to be the animal model most representative of influenza in humans, against 2009 "swine flu" strains. Titer levels achieved were above the protection threshold considered to be protective against influenza infection in humans.
PENNVAXTM HIV DNA Vaccines
In October, the HIV Vaccine Trials Network (HVTN) initiated a phase I clinical study in a preventive setting of Inovio's PENNVAX?„?-B DNA vaccine delivered using its proprietary electroporation technology. The multi-center study is enrolling healthy volunteers to assess safety and immune responses.
A second IND is now open, allowing testing of PENNVAX?„?-B in a therapeutic setting. This Phase I trial (HIV-001) is being conducted in collaboration with the University of Pennsylvania and targets HIV-positive individuals. The electroporation-delivered PENNVAX?„?-B arm of this trial will start in early 2010.
In 2010, Inovio plans to initiate a new prophylactic HIV Phase I trial (RV262) in collaboration with the US Army. The study will test PENNVAX?„?-G delivered with electroporation in conjunction with a modified vaccinia Ankara- Chiang Mai double recombinant boost.
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.
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.
Research & Development
In July the company 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.
Ongoing investments are being made to further advance and optimize the company's electroporation delivery technology. Subsequent to year end, Inovio unveiled a new clinical-grade, miniaturized electroporation device designed to be an easy-to-use, portable delivery product for DNA vaccines. This new skin electroporation technology has been used to deliver DNA vaccines in several preclinical animal models and generated strong, protective antibody responses, which are required to provide immunity against targeted diseases. The company also announced a new hand-held, cordless electroporation device design. Inovio believes these devices may be used to inoculate large populations against infectious diseases such as influenza, dengue and malaria.
SOURCE Inovio Biomedical Corporation