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Inviragen Wins Follow-on NIH Grant to Develop Dengue Fever Vaccine with UW-Madison, CDC

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By Ben Butkus

Vaccine developer Inviragen has won a $600,000 Phase II Small Business Innovation Research grant to work with the University of Wisconsin and the US Centers for Disease Control and Prevention to develop a second-generation vaccine for dengue fever.

This grant, from the National Institutes of Allergy and Infectious Disease, is the second major NIH award Inviragen has received to develop a dengue fever vaccine. The first, a $2.7 million grant awarded in 2006, has allowed the company and its academic partners to develop the first-generation version of the vaccine.

The latest award also further strengthens Inviragen's ties to UW-Madison, where the company's CSO Jorge Osorio maintains an academic appointment and a research lab within the School of Veterinary Medicine that has collaborated with Inviragen on several projects, including a vaccine for avian influenza virus.

The dengue fever virus is based on technology originally developed at the CDC's Division of Vector-Borne Infectious Diseases, Dan Stinchcomb, Inviragen's CEO, told BTW this week. Inviragen in 2006 exclusively licensed the technology, which is applicable to other tropical viral diseases such as West Nile.

Dengue fever is caused after an individual becomes infected with one of four distinct RNA viruses: DEN-1, DEN-2, DEN-3 or DEN-4. To be safe and effective, dengue vaccines must be capable of neutralizing all four viruses, Inviragen said.

Inviragen is developing a four-way, or tetravalent, vaccine using the CDC’s technology, a vaccine backbone that was shown to be safe and that could generate long-lasting immune responses in Phase 1 clinical trials of other vaccine types.

The $2.7 million NIH grant, which is set to expire in 2010, enabled Inviragen to move the vaccine through pre-clinical testing.

"We'll have a clinical trial ready for the first-generation vaccine in 2010," Stinchcomb said. "But we've now realized that we can re-engineer the vaccine to elicit a stronger immune response." The new SBIR grant will fund the engineering and pre-clinical testing of the second-generation vaccine.

"We're still confident in the first vaccine, but we'll incorporate the second-generation vaccine later in clinical trials," Stinchcomb said.

Inviragen, based in Fort Collins, Colo., will work with Osorio's labs at UW-Madison to conduct pre-clinical testing on the latest iteration of the dengue vaccine. "They have fantastic animal- and vaccine-testing facilities" that have enabled most of the company's pre-clinical testing to date, Stinchcomb said.

Although the joint dengue work with UW-Madison is unlikely to produce any new IP — the original IP from CDC was "fairly well developed," Stinchcomb said — it will strengthen a relationship between the company and the school that has been ongoing since at least 2006.

The collaboration has benefitted Inviragen enough that the company earlier this year opened its own vaccine research lab near Madison to facilitate cooperative research with the school. The office currently has four full-time employees, Stinchcomb said.

Inviragen disclosed its plan to open the satellite office in 2007, around the time it announced it had won another two-year, $600,000 Small Business Technology Transfer grant from NIH.

That award required Inviragen to co-develop with UW-Madison an avian influenza vaccine (see BTW, 11/26/2007) based on a second-generation vaccinia Ankara vector that Stinchcomb and Osorio began developing in the early 1990s while employed at veterinary medical company Heska.

Modified vaccinia Ankara, or MVA, is a vector that has been widely used in various vaccine preparations.

When Inviragen received the avian flu STTR grant, Stinchcomb told BTW that the company had previously signed an agreement with the Wisconsin Alumni Research Foundation outlining the potential ownership of IP arising from the alliance. Currently, Inviragen owns the basic vaccine vector technology while WARF owns the various avian flu antigen IP.

This week, Stinchcomb said that there will "definitely" be new IP coming from the avian flu collaboration, but that patent applications have not yet been filed. "We expect to soon," he said.

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