Inovio Pharmaceuticals, Inc. announced late Wednesday that significant T cell and antibody responses were generated in its Phase I clinical study of VGX-3400X, a SynCon™ DNA vaccine for the prevention of avian H5N1 influenza delivered using intramuscular (IM) electroporation.
Inovio is engaged in developing what are called DNA vaccines for treatment and prevention of cancers and infectious diseases. Among these drugs are its SynCon™ vaccines, which are designed to protect against known as well as newly emergent strains of pathogens such as influenza. The company also offers its proprietary electroporation delivery devices, which have been shown to be safe and generate significant immune responses, and it’s currently engaged in three Phase II studies for vaccines to treat cervical dysplasias, cervical cancer, hepatitis C virus, and leukemia.
According to its website, Inovio is broadly partnered or collaborating with the University of Pennsylvania, Merck (NYSE: MRK), ChronTech (Stockholm: CTEC), National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, and PATH Malaria Vaccine Initiative. Its SynCon™ flu DNA vaccine using intramuscular electroporation has already shown strong antibody response in 96% of subjects and significant T-cell responses in 72% of subjects.
Results were announced in San Diego at “DNA Vaccines 2011,” hosted by the International Society of DNA Vaccines, by Dr. Niranjan Sardesai, Inovio’s Sr. VP, Research and Development.
Electroporation is a method of introducing a substance into a cell, such as a drug, molecular probe, or DNA fragment, by applying an electrical field to the skin. Intradermal delivery of a vaccine antigen is considered desirable because the dermal layer of skin is especially susceptible to reacting by producing antibodies, such as killer cells, to the antigen.
The company also announced launch of a second Phase I clinical study as part of its universal influenza vaccine program. “This trial will assess a multi-subtype SynCon vaccine for H1N1 and H5N1 influenza using its skin-targeted intradermal (ID) electro orator,” said the company release. The SynCon™ vaccine design process “uses a proprietary method to achieve cross-strain protection against the natural and frequent mutations of influenza strains within subtypes.”
Inovio CEO Dr. J. Joseph Kim stated, “We are encouraged by the immune responses generated in this proof-of-principle study of our first SynCon™ influenza vaccine, VGX-3400X, delivered using intramuscular electroporation. The second Phase I study (INO-3510) builds on our universal influenza vaccine development program by adding a second component targeting the H1N1 subtype and delivering vaccine formulations using our minimally invasive intradermal electroporation delivery system, which is designed to directly access the skin tissue that is most ideal for inducing preventive antibody responses. Inovio’s ultimate goal is to develop a broadly cross-protective influenza vaccine simultaneously targeting multiple flu sub-types and unmatched strains within subtypes. We are approaching this goal in a modular manner and we look forward to generating data from this study using a multi-antigen vaccine, which we expect in the first quarter of 2012.”