SOURCE: GlobeImmune, Inc.

GlobeImmune, Inc.

February 08, 2012 07:00 ET

GlobeImmune Initiates Phase 1 Clinical Trial of GI-6301 in Brachyury Expressing Cancers

GI-6301 Is GlobeImmune's Third Oncology Tarmogen® Product to Begin Human Clinical Trials

LOUISVILLE, CO--(Marketwire - Feb 8, 2012) - GlobeImmune, Inc. today announced the initiation of a Phase 1 clinical trial to be conducted at the National Cancer Institute (NCI) to investigate the safety and tolerability of GI-6301, a new Tarmogen product, for patients with metastatic cancers containing brachyury protein. Brachyury is over-expressed in a variety of important tumor types including breast, colon, lung and prostate cancers.

"Targeting the metastatic evolution of cancer is a unique application of our Tarmogen platform and for immunotherapy in general," said Timothy C. Rodell, M.D., President and CEO of GlobeImmune. "This trial potentially expands the utility of our Tarmogen platform that has already shown promise in patients with tumors expressing CEA and mutated Ras. We look forward to working with our NCI colleagues to successfully advance GI-6301 through the clinic."

The GI-6301 Tarmogen was jointly developed by GlobeImmune and NCI under a Collaborative Research and Development Agreement (CRADA). Preclinical studies supporting the filing of the IND were conducted at the Laboratory of Tumor Immunology and Biology (LTIB) at NCI led by Drs. Claudia Palena and Jeffrey Schlom. The single-center Phase 1 study will be funded by the NCI. The GI-6301-01 study is an open-label, dose-cohort escalation trial in patients with metastatic cancers with a high incidence of brachyury expression. The primary endpoint of the study is the safety and tolerability of escalating doses of GI-6301 given as a single agent. Secondary endpoints include levels of brachyury-specific T cells, reduction in brachyury serum markers and circulating tumor cells and evidence of clinical benefit. James L. Gulley, M.D., Ph.D., F.A.C.P., Director of the Clinical Trials Group, LTIB, will be the Principal Investigator for the study.

About the GI-6301 Tarmogen
The GI-6301 Tarmogen consists of whole, heat-killed, recombinant S. cerevisiae yeast genetically modified to express high levels of brachyury protein. Brachyury is over-expressed in cancer cells compared with normal tissue and is believed to play a significant role in the progression of cancer from a localized to metastatic disease (the epithelial-to-mesenchymal transition, or EMT). Targeting brachyury using the GI-6301 Tarmogen is intended to arrest progression of disease by eliminating the subset of tumor cells that acquire drug resistance and the ability to migrate and invade distant tissues.

About GlobeImmune
GlobeImmune is developing a new class of immunotherapy products called Tarmogens® that are designed to elicit a targeted T cell immune response to eliminate diseased cells. The immune system plays a critical role in controlling chronic infection and cancer. The Tarmogen platform is designed to reconstitute an appropriate immune response in patients to fight their disease. To date, Tarmogen products have been well tolerated in multiple disease indications and are efficient and scalable to manufacture. GlobeImmune has raised over $160 million to date in support of its programs. In July 2008, GlobeImmune signed a CRADA with NCI and the National Institutes of Health to jointly develop multiple product candidates intended to treat a variety of cancers. In May 2009, the Company announced a global partnership with Celgene focused on the discovery, development and commercialization of multiple product candidates for the treatment of cancer. In October 2011, the Company signed an exclusive research collaboration and license with Gilead to develop Tarmogens for the treatment of chronic hepatitis B (HBV) infection. For additional information, please visit the Company's website at www.globeimmune.com.