Inviragen and PharmaJet Receive NIAID Contract to Develop Needle-free Dengue Vaccine

Inviragen and PharmaJet announce the award of a five year, $15.5 million dollar contract from the National Institute of Allergy and Infectious Diseases (NIAID) to advance the development of a needle-free, easy to administer dengue vaccine. The award will fund preclinical studies, regulatory filings, manufacturing and clinical testing of Inviragens tetravalent dengue vaccine, DENVax delivered with PharmaJets convenient needle-free injection device.

"This NIAID contract will allow Inviragen and PharmaJet to continue our pioneering development of a needleless dengue vaccine," says Dr. Dan Stinchcomb, Inviragens CExO. "The PharmaJet injector has many properties that make it ideal for administering a dengue vaccine worldwide, potentially saving lives in affected countries and reducing the spread of the disease to new regions."

More than 3.5 billion people live in countries that have frequent dengue outbreaks. The four dengue viruses are spread among humans by mosquitoes and cause an estimated 30 million to 50 million cases of debilitating dengue fever and 0.5 million to 2 million cases of life-threatening dengue hemorrhagic fever every year. A recent dengue outbreak in Florida highlights the continuing global spread of the disease.

"People of all ages fear needles and safe disposal of needle waste is a constant problem for health care providers. A needle-free dengue vaccine would be welcomed by patients in endemic countries and by travelers worldwide and could protect them from this devastating disease," says Dr. Linda McAllister, PharmaJets interim CEO. "In this collaboration, PharmaJet will develop needle-free syringes compatible with our jet injection technology for pre-filling with Inviragens novel dengue vaccine."

Inviragens DENVax vaccine, developed by researchers at the CDCs Division of Vector-Borne Diseases, is based on an attenuated DEN-2 virus that generates long-lasting anti-dengue immune responses. CDC scientists engineered this clinically tested, weakened DEN-2 virus to express DEN-1, DEN-3 or DEN-4 structural genes. DENVax is a four-way mixture of the three engineered viruses and the original DEN-2 strain. Inviragen has completed preclinical testing, formulation, and manufacturing of DENVax. Phase 1 clinical safety testing of DENVax, delivered by traditional needle and syringe, began earlier this year. Other dengue vaccine technologies in clinical testing require multiple injections with long intervals between doses. The goal of the Inviragen/PharmaJet collaboration is to develop a needle-free dengue vaccine delivery platform that can rapidly induce neutralizing antibody response after one or two easily administered doses.

PharmaJets jet injector creates a fine stream of pressurized liquid that penetrates the skin, quickly and effectively delivering doses of medicines and vaccines into different tissues. Jet injection eliminates needles from the process of administering vaccines and eliminates the costs and dangers associated with sharp needle waste. PharmaJets technology is FDA-cleared for delivery into the muscle and under the skin. PharmaJet is developing jet injectors for delivery between the skin layers. For some vaccines, intradermal delivery has the potential to reduce the amount of vaccine required, leading to cost savings and expanded coverage for vaccines in limited supply.

"In preliminary animal model studies, we used PharmaJet technology to deliver DENVax intradermally. The combination was safe, induced neutralizing antibodies to all four dengue serotypes and protected against dengue infection," notes Dr. Jorge Osorio, Inviragens chief scientific officer. "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 that are significantly impacted by dengue disease."