We are a biopharmaceutical company focused on developing therapeutic products for cancer and infectious diseases based on our proprietary Tarmogen® platform. The Tarmogen platform activates the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines, which predominately stimulate antibody production. We have four Tarmogen product candidates in six ongoing clinical trials. Our lead cancer product candidate, GI-4000, is being evaluated in combination with gemcitabine in a fully enrolled, placebo-controlled Phase 2b trial in resected pancreas cancer. Our lead infectious disease product candidate, GI-5005, has completed a Phase 2b trial in patients with chronic hepatitis C virus, or HCV, infection.
Strategic alliance with Celgene for oncology. We established a worldwide collaboration with Celgene Corporation (Celgene) in May 2009 to develop oncology Tarmogens. Under the agreement, we granted Celgene the exclusive option, on a program-by-program basis, to all of our oncology programs. For each such program, we will conduct early development of the product candidates through certain predefined endpoints, at which time Celgene will have the right to exercise its option and obtain the exclusive license to develop and commercialize the product candidates in such program. After the exercise of the option, Celgene will be solely responsible for the development and commercialization of the applicable products.
Strategic alliance with Gilead for chronic hepatitis B virus (HBV) infection. In November 2011, we licensed to Gilead Sciences, Inc. (Gilead) worldwide rights to our HBV Tarmogen program. Under the agreement, we granted Gilead exclusive worldwide rights to use our platform technology on Tarmogens to research, develop, and commercialize vaccine products directed at HBV. We will collaborate with Gilead on the development of our HBV Tarmogen product candidates in conjunction with Gilead’s drug, Viread® (tenofovir disoproxil fumarate), and other oral therapies for the treatment of chronic HBV infection.
National Cancer Institute (NCI) – Cooperative Research and Development Agreement. We are party to a Cooperative Research and Development Agreement (CRADA) with the NCI, entered into in 2008. Under the CRADA, we and the NCI will jointly develop products intended to treat a variety of cancers, through collaborative research and development activities set forth in a research plan. We will utilize our proprietary Tarmogen technology to develop multiple immunotherapy products expressing various cancer antigens provided by the NCI, and the NCI will conduct and fund preclinical and early clinical development of the product candidates.