Gilead will support Phase Ia trials and then has an option to take over development.

Gilead and GlobeImmune Inked an exclusive worldwide license and collaboration agreement centered on the development of therapeutic vaccines for use in combination with Gilead’s marketed drug Viread® (tenofovir disoproxil fumarate) and other treatments for chronic hepatitis B virus (HBV) infection. Gilead will pay its partner an up-front payment and provide support for GlobeImmune’s continued development of its HBV therapeutic vaccine through Phase Ia clinical trials. Gilead will then be able to take over full responsibility for further development of the vaccine, in return for additional development milestones and royalties on future sales.

GlobeImmune is focused the development of therapeutic Tarmogen vaccines for the treatment of infectious diseases and cancer. Tarmogen vaccines are whole, heat-killed recombinant Saccharomyces cerevisiae yeast cells engineered to produce one or more target disease antigens, such as viral proteins or cancer-associated proteins. The company’s lead infectious disease product candidate, GI-5005, is a Tarmogen vaccine in Phase II development for the treatment of chronic hepatitis C infection (HCV). 

The collaboration with Gilead aims to generate therapeutic vaccine products that have a specific HBV DNA antigens cloned into S. cerevisiae. The firms anticipate that combining a therapeutic vaccine with oral suppressive antiviral therapy will help increase surface antigen (HBsAg) loss with seroconversion. “Based on the proof-of-concept studies in hepatitis C infection, we believe that the combination of GlobeImmune’s Tarmogen immunotherapy products with oral suppressive antiviral therapy will help eliminate the cells harboring the hepatitis B virus, thus increasing seroconversion within a finite period,” remarks David Apelian, M.D., senior vp of R&D, and CMO at GlobeImmune.

Gilead reported sales of Viread for the treatment of HIV infection and chronic HBV were $185.7 million in the second quarter of 2011, up from $176.2 million in the second quarter of 2010. 

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