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Published On: Mon, Jan 14th, 2013

Inviragen CEO, Dr. Dan Stinchcomb gives an update on the DENVax dengue fever vaccine

Photo/CDC/ Debora Cartagena

Photo/CDC/ Debora Cartagena

It’s in the news on a regular basis these days, a dengue fever outbreak here, an epidemic there, even Europe experienced their first sustained transmission of dengue since the 1920′s with the recent Madeira Island outbreak.

The US Centers for Disease Control and Prevention says that more than one-third of the world’s population is living in areas at risk for transmission and dengue infection is a leading cause of illness and death in the tropics and subtropics. As many as 100 million people are infected yearly.

With this in mind, a vaccine against this mosquito borne viral disease seems to be in more need than ever before.

Dr. Dan Stinchcomb, CEO and Co-founder of the Fort Collins, CO vaccine company, Inviragen spoke to The Global Dispatch today about the latest news and progress on Inviragen’s DENVax vaccine.

Herriman: There has been an uptick of dengue in the US. Hawaii, Key West and Brownsville TX have seen outbreaks and as Mary McKenna recently reported in Slate, both the Aedes aegypti and Aedes albopictus mosquitoes, vectors of dengue, are being seen as far north as NYC and Chicago. In your opinion, what explains the resurgence of both dengue fever, including locally acquired cases, and the vector in this country?

Dr. Stinchcomb: Since the mosquito spreads the dengue virus from human to human, the transmission is affected by human population density, the number of people that are dengue infected and mosquito prevalence.  As you noted, the mosquito vectors for dengue are increasing in the U.S.  Since these are tropical mosquitoes, they prefer wet, warm climates and many population centers in the U.S. are experiencing higher temperatures and severe wet weather.   Simultaneously, the dengue virus in increasing in incidence in Central and South America and in Asia; thus, more dengue infected individuals are traveling to the U.S.  Along with growing city populations, these factors lead to conditions that are ripe for continued dengue outbreaks in the United States and worldwide.

Herriman: Dengue epidemics are increasing across the globe. The need for a dengue vaccine is growing more critical. What is the latest status on Inviragen’s DENVax?

Dr. Stinchcomb:  Inviragen’s DENVax vaccine has successfully completed two Phase 1 clinical trials.  In these studies, we demonstrated that the vaccine is safe and well-tolerated in healthy adults that had not been exposed to dengue.  In addition, we showed that the vaccine induced antibodies that were capable of neutralizing each of the four dengue viruses.  We are currently conducting an in-depth Phase 2 trial testing the safety and immune response to the vaccine in multiple age groups in dengue endemic countries.  Last year we completed the first stage of the study and demonstrated that the vaccine is safe in all ages in these settings.  We are now enrolling hundreds of additional children from 1.5 to 11 years of age.  If the Phase 2 trial continues to proceed well, we are planning to begin studies to test the ability of our dengue vaccine to prevent dengue fever in these countries in late 2013/early 2014.

Herriman:  What are some of the biggest obstacles you have encountered in getting DENVax through clinical trials?

Dr. Stinchcomb: To be honest, the first challenge for a biotechnology company like Inviragen is funding.  When we started Inviragen in 2006, there was little awareness of dengue and less interest in vaccines.  In 2009, we found four venture investors – two in the U.S. and two in Singapore – with the foresight to invest in our company.  To date, they have provided $24m to help fund the clinical trials of our lead vaccines.  In addition, we have raised over $30m in grant and contract funding from the NIH, the Dengue Vaccine Initiative (funded by the Gates Foundation), and the Singapore Economic Development Board to supplement the investor financing.  Together, these funds have supported our preclinical studies, our vaccine manufacturing and our Phase 1 and 2 clinical trials for DENVax and for our hand, foot and mouth disease vaccines.

The second major challenge is that moving a vaccine from the research bench to the clinic requires a very diverse set of specialties, such as GMP manufacturing, formulation, preclinical models, immunology, quality and clinical assay development and clinical trial design and execution.  For vaccines, these talents ordinarily exist only in major pharmaceutical companies.  Our business model was to cost-effectively translate vaccine research to vaccine products in a small biotech setting.  At Inviragen, we have a team of very talented individuals focusing on select areas where expertise did not exist in the dengue research community.  Then, to support our internal development efforts, we built a network of scientists, clinicians, and collaborators from across the globe that have helped move the vaccine forward.

Herriman:  How is Inviragen’s progress towards vaccine approval versus your competitors?

Dr. Stinchcomb: Sanofi Pasteur has had the leading dengue vaccine in clinical testing for several years.  In September of last year, Sanofi published the results of the first dengue vaccine efficacy study with their vaccine in Lancet. The vaccine was reportedly effective against three of the four serotypes of dengue, but failed to offer protection against dengue serotype 2.  Unlike the Sanofi vaccine, which uses a yellow fever backbone, Inviragen’s DENVax vaccine was engineered with a dengue-2 backbone.  As a result, our vaccine has the potential to generate more potent immune responses (both antibodies and cell-based responses that can deliver a one-two knock-out punch to the dengue-2 virus) than Sanofi’s vaccine.  Also unlike the Sanofi vaccine, which is delivered in three doses that take a full year to administer, DENVax is delivered in only two doses in three months.

The Sanofi results were encouraging to the dengue vaccine field.  Their study demonstrated the safety of the vaccine approach and that partial protection could be achieved.  Indeed, Sanofi is continuing with additional Phase 3 efficacy studies to better understand the level of protection that their vaccine provides.  Providing our ongoing trials continue to show promising results, Inviragen’s DENVax vaccine could be the next candidate to be tested in field efficacy studies.  Dengue is a significant health threat to almost half of the world’s population, so several other vaccine manufacturers have vaccines in earlier stages of clinical testing, including GSK, Merck and some developing world vaccine manufacturers.

Herriman: When do you expect to have a dengue fever vaccine on the market?

Dr. Stinchcomb:  With successful completion of our ongoing clinical studies, Inviragen could start the key vaccine efficacy trials in the late 2013/early 2014 timeframe.  These studies are likely to take two years to complete so if all goes well then DENVax could be approved in 2016 and on the market as early as 2017.

Thank you Dr. Stinchcomb for answering these questions about this very important product development.

Inviragen is addressing unmet needs in this growing global vaccine marketplace and has created a team of dedicated vaccine development specialists in the United States and Singapore.  The company has research and corporate operations in Fort Collins, Colorado, vaccine testing capabilities in Madison, Wisconsin, and vaccine development operations in Singapore.  Inviragen’s international vaccine development teams utilize global resources and capabilities to bring vaccine concepts to reality.  This strategy positions Inviragen to capitalize on the need for novel infectious disease vaccines in emerging economies.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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