Gilead and GlobeImmune Will Collaborate on Hepatitis B Therapeutic Vaccine

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Gilead Sciences and GlobeImmune announced this week that they will collaborate on the development and commercialization of a hepatitis B virus (HBV) therapeutic vaccine using GlobeImmune's Tarmogen yeast vector technology. In contrast to widely used HBV preventive vaccines, therapeutic vaccines are designed to stimulate the body's immune response to the virus, and may be used in conjunction with oral antiviral drugs.

Below is an edited excerpt from a joint company press release describing the agreement.

Gilead and GlobeImmune Announce License and Collaboration Agreement to Develop Therapeutic Vaccine Products for Treatment of Chronic Hepatitis B Infection

Foster City, Calif. and Louisville, Colo. -- October 24, 2011 -- Gilead Sciences, Inc. (Nasdaq:GILD) and GlobeImmune, Inc. today announced that the companies have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of therapeutic vaccine products for use in conjunction with Viread (tenofovir disoproxil fumarate) and other oral therapies for the treatment of chronic hepatitis B virus (HBV) infection.

Under the terms of the agreement, Gilead will pay GlobeImmune an upfront payment and provide support for GlobeImmune's continued development of its HBV therapeutic vaccine program through Phase 1a clinical trials. Gilead can assume full responsibility for clinical development following Phase 1a. GlobeImmune also could receive additional payments based upon achievement of certain development milestones, as well as royalties on future potential net sales.

The goal of the research collaboration is to create and develop therapeutic vaccine products that have specific HBV DNA antigens cloned into S. cerevisiae (a species of yeast). The companies anticipate that the combination of a therapeutic vaccine with oral suppressive antiviral therapy could help increase surface antigen (HBsAg) loss with seroconversion -- a marker of the resolution of chronic HBV infection.

"This collaboration is a significant milestone in GlobeImmune's efforts to advance therapies for major unmet medical needs," said David Apelian, MD, PhD, Senior Vice President Research and Development and Chief Medical Officer at GlobeImmune. "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."

"Finite therapy remains a significant unmet need for patients with chronic hepatitis B," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We are hopeful that this approach will allow us to explore whether adaptive immunomodulatory approaches to HBV will help us improve HBsAg seroconversion, thereby eliminating the need for life-long daily therapy."

About GlobeImmune

GlobeImmune, Inc. is a private company developing therapeutic vaccines called Tarmogen products for the treatment of cancer and infectious diseases. Tarmogens stimulate the natural production of T-cells that are capable of locating and eliminating cancer cells and virally-infected cells. GlobeImmune has raised over $160 million to date in support of its programs. For additional information, please visit the company's website at www.globeimmune.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific. For more information on Gilead, please visit www.gilead.com.

10/28/11

Source

Gilead Sciences and GlobeImmune. Gilead and GlobeImmune Announce License and Collaboration Agreement to Develop Therapeutic Vaccine Products for Treatment of Chronic Hepatitis B Infection. Press release. October 24, 2011.