Inviragen and PharmaJet have received five year, $15.5m award from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to advance the development of a needle-free, easy to administer dengue vaccine.
The award is expected to fund preclinical studies, regulatory filings, manufacturing and clinical testing of Inviragen’s tetravalent dengue vaccine, DENVax delivered with PharmaJet’s convenient needle-free injection device.
Inviragen CEO Dan Stinchcomb said that the NIAID contract will allow Inviragen and PharmaJet to continue their development of a needleless dengue vaccine.
PharmaJet interim CEO Linda McAllister said that in the collaboration, PharmaJet will develop ‘needle-free’ syringes compatible with their jet injection technology for pre-filling with Inviragen’s new dengue vaccine.
Inviragen claimed that its DENVax vaccine, developed by researchers at the CDC’s Division of Vector-Borne Diseases, is based on an attenuated DEN-2 virus that generates anti-dengue immune responses.
PharmaJet claimed that its technology is FDA-cleared for delivery into the muscle (intramuscular) and under the skin (subcutaneous).
Inviragen chief scientific officer Jorge Osorio said that in preliminary animal model studies, they used PharmaJet technology to deliver DENVax intradermally.
“The combination was safe, induced neutralising antibodies to all four dengue serotypes and protected against dengue infection,” Osorio said.
“Our ongoing Phase 1 clinical trial is assessing the safety and immune responses after both subcutaneous and intradermal delivery of DENVax by needle.
“Under this NIAID contract, we aim to test DENVax delivery with the PharmaJet device in children and adults in South America and Southeast Asia, regions.”