Inovio announces publication of minimally-invasive intradermal device in journal Gene Therapy

Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that a peer-reviewed research article describing the development of a new intradermal, minimally-invasive DNA vaccine delivery device was published in the prestigious journal Gene Therapy. This very low voltage device, which does not penetrate the skin, further enhances the previously established tolerability of Inovio's electroporation devices. Moreover, DNA vaccines delivered using this device produced strong antibody and T-cell immune responses and achieved protection from lethal challenge in multiple animal models including non-human primates. The lead author of the paper, "Prototype development and preclinical immunogenicity analysis of a novel minimally invasive electroporation device," was Dr. Niranjan Y. Sardesai, Senior Vice President, Research & Development. Other collaborators included Dr. David B. Weiner, Chair of Inovio's Scientific Advisory Board and Professor, Department of Pathology & Laboratory Medicine, University of Pennsylvania.

“Prototype development and preclinical immunogenicity analysis of a novel minimally invasive electroporation device”

Inovio's new minimally-invasive intradermal device is based on its electroporation delivery platform in which controlled, millisecond electrical pulses create permeability in cell membranes and enable dramatic uptake of biological material previously injected into targeted muscle or skin tissue. Inovio's electroporation systems have been shown to increase cellular uptake of a DNA vaccine 1000-fold or more and to increase levels of gene expression (production of the antigen coded by the DNA vaccine) and immune responses to the antigen up to 100-fold.

While current Inovio electroporation devices have been shown to be safe and well-tolerated in multiple human studies, Inovio has been advancing research into more portable and patient-friendly next-generation delivery devices. In this context, the study reported in Gene Therapy used voltages averaging roughly seven times less than its current devices. The paper noted that the use of non-penetrating needle electrodes and lower-voltage parameters encompassed in this device concept further improves tolerability of this delivery platform. By enabling simple delivery into the skin, this device can serve to expand applications for DNA delivery in humans to broader prophylactic settings, i.e. for mass vaccinations, and may extend the range of immunizations to both older and younger populations. This new device also facilitates the delivery of more complex formulations and antigen mixtures that may better address targeted diseases.

The authors investigated the delivery of candidate influenza DNA vaccines, demonstrating that DNA delivered intradermally via the minimally-invasive (equivalent to a slight scratch of the skin), low-voltage device conferred 100% protection in a mouse model to the vaccinated animals against a lethal challenge of influenza H5N1. Influenza DNA vaccine delivered via the device also produced HA-inhibition (HAI) titers significantly over 1:40 in two other large animal models including in non-human primates. While these large animals were not subsequently challenged in this study, titers greater than 1:40 are considered to be protective in the influenza model in a number of species.

Dr. J. Joseph Kim, CEO of Inovio Pharmaceuticals, said, "Inovio is the clear leader in DNA vaccine development and delivery. This important study unveils our exciting, next generation minimally-invasive drug delivery technology and enables the development of a new generation of preventive vaccines against many challenging diseases and for a broad spectrum of the population. We look forward to continuing our R&D leadership in this field."

Source: Inovio Pharmaceuticals, Inc.