Gates Foundation, PDVI fund Inviragen research

FORT COLLINS – Inviragen Inc. is one step closer to testing its vaccination for dengue fever in humans, thanks to financial support from the international Pediatric Dengue Vaccine Initiative.

The Fort Collins-based company, headed by Dan Stinchcomb, officially began its relationship with PDVI in September. The International Vaccine Institute, based in Seoul, South Korea, launched the PDVI program in 2001. In July 2003, it received major financial backing from a $55 million grant from the Bill & Melinda Gates Foundation. The goal of the initiative is to accelerate introduction of a dengue vaccine for humans.

The mosquito-borne dengue viruses – there are four different strains – are a public health problem in Southeast Asia, the Pacific Islands, the Caribbean, Mexico, Central and South America and parts of Africa. Dengue or bonebreak fever threatens more than 2.5 billion people throughout the world, with about 100 million to 150 million infected with the disease annually.

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Inviragen is working on a vaccine to protect against all four strains, with help from the federal Centers for Disease Control and the University of Wisconsin. The PDVI funding will help cover the cost of manufacturing the vaccine for trials.

“That’s one of our biggest costs,” Stinchcomb explained. The company is not releasing information on the exact amount of the funding, but Stinchcomb said it would cover about half of the manufacturing costs during the clinical trials.

Two years ago, Inviragen selected Shantha Biotechnics Ltd. of India as its manufacturing partner, and the company is now ramping up approved vaccination stocks. Before approving the funding, PDVI evaluated the Fort Collins-based labs of Inviragen and the CDC, where some of the vaccine work is done, as well as Shantha’s facilities.

In addition to the financial benefit, the funding also presents a positive side effect.

“This also provides additional validation for the vaccine,” Stinchcomb said.

PDVI’s global mission

Inviragen’s relationship with PDVI will continue after the manufacturing costs are covered, because the organization’s financial assistance is only a small portion of its mission.

“We are setting up field sites in as many as 10 countries,´ said Richard Mahoney, director of vaccine access and senior adviser of strategic program development for PDVI. He explained that the sites would be used to conduct a variety of studies, including surveillance of the disease, health-care needs and clinical trials.

“The India site could be good for Inviragen’s clinical trials,” he said, adding that it could be set up by the time the company is ready for its later-stage clinical trials.

PDVI is also gathering economic information that will be useful for Inviragen and other companies when determining the pricing and funding needs in the dengue-affected areas, and working with industry giants GlaxoSmithKline PLC and Sanofi-Aventis as well as several bioscience companies in India and Brazil.

Mahoney said that PDVI has been interacting with Inviragen for a couple of years.

“We’ve been very impressed with the quality of their work,” he said. “We believe that the vaccination they’re working on is one of the most-promising candidates.”

The process of vaccine commercialization is a long and expensive one, requiring many stages and approvals just to get to the human-clinical-trials stage. Even with a promising technology, Inviragen is still four years from commercializing its dengue vaccine, in a best-case scenario.

Other projects

Inviragen’s business model focuses on developing vaccines for developing nations as well as for biodefense. With the dengue vaccine, the company will first seek approvals in the countries where the disease is most prevalent, then will focus on the United States and other nations where travelers might be interested in the vaccine.

Another important part of Inviragen’s business plan calls for the company to leverage investor funds with grants and other financial assistance, such as that from PDVI. The company recently also landed a $600,000 grant from the National Institutes of Health for its work with the University of Wisconsin on an avian-influenza vaccine.

The two-year grant will fund construction and testing of novel vaccines currently under construction. The company plans to use technology to nasally administer the vaccine that it had originally developed for a plague/smallpox vaccine. The idea is to create mucosal immunity for the airborne disease.

The grant is part of the Small Business Technology Transfer program through the NIH. Inviragen has had previous success with grants from the agency. Last November, the company landed a $1.3 million grant from the NIH for the dengue vaccine.

“It’s hard to raise money, and he’s been successful with the grant process,´ said Kathy Kregel, director of Fort Collins’ bioscience cluster. She added that Stinchcomb has proved to be very resourceful, turning over every stone in order to reach his goals.

All that hard work is paying off for the company, and people are noticing. Kregel said that Stinchcomb and Inviragen are one of the nominees for the BioWest Conference Bioscience Rising Star award. The winners of all this year’s awards will be announced at BioWest in Denver on Dec. 7.

“Every time he gets a grant, he enhances his business proposition,” she said. The company is making headway without relying on additional funds from existing investors.

Kregel feels that Stinchcomb’s business plan of leveraging investor funds with grants and other sources is the best way to go for early-stage companies.

“Inviragen is a great role model (for the cluster),” Kregel said. “We’re lucky to have them here in Northern Colorado.”