GlobeImmune's GI-4000 in Combination with Gemcitabine Following Surgery Shows Evidence of an Improvement in Survival in a Phase 2b Clinical Trial with Ras Mutation Positive Pancreas Cancer
Phase 2b Survival Data of R1 Resection Subjects Presented at ESMO 14th World Congress on Gastrointestinal Cancer
BARCELONA, Spain - June 27, 2012 - GlobeImmune, Inc., today announced that GI-4000 in combination with gemcitabine showed evidence of an improvement in overall survival for subjects with Ras mutation positive pancreas cancer with microscopic residual disease after surgery (R1 subjects). The initial Phase 2b data were presented by Donald A. Richards, M.D., Ph.D., at the European Society for Medical Oncology (ESMO) 14th World Congress on Gastrointestinal Cancer.
GI-4000 is GlobeImmune's lead cancer program targeting cancers expressing mutations in the Ras protein. Ras mutations are found in approximately 90 percent of pancreas cancers and result in uncontrolled proliferation of malignant cells. Pancreas cancer is rarely curable, with a median survival of 9 to 12 months and an overall five-year survival rate of three percent for all stages of the disease.
A 2.6 month improvement in median overall survival was observed in R1 subjects treated with GI-4000 in combination with gemcitabine (n=19; 17.2 months) versus subjects treated with gemcitabine and placebo (n=20; 14.6 months), representing an 18 percent relative improvement. A 5.0 month improvement in median overall survival was observed for treated R1 subjects characterized as immune responders to mutated Ras in comparison to the placebo group. For the R1 subjects treated with GI-4000 plus gemcitabine, a one month improvement in median recurrence free survival was observed compared to the R1 subjects who received placebo plus gemcitabine (9.6 vs. 8.5 months, respectively). These numerical improvements in outcome did not achieve statistical significance.
Exploratory proteomic signature analysis not specified in the original trial protocol was performed by Biodesix, Inc., on baseline plasma samples from 90 R1 and R0 subjects from this study, with R0 status being defined by the absence of microscopic residual disease at the surgical margin. The analysis revealed a proteomic signature that was associated with improved clinical outcomes in the GI-4000 treated group, but not in the placebo group. The exploratory signature was observed in approximately half of tested study subjects (16 of 44 in the GI-4000 group and 26 of 46 in the placebo group). The specific proportion of patients could change with further development of the diagnostic. This signature could, if prospectively validated, have the potential for use as an enrichment marker in future clinical trials.
"We estimate that Ras mutations are found in approximately 180,000 new cancer cases each year in the United States, and studies have shown that tumors with Ras mutations are generally less responsive than tumors with normal Ras to conventional chemotherapy as well as approved targeted agents," said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. "We believe that a therapy that promotes cellular immune responses to mutated Ras, such as GI-4000, may improve outcomes in resected patients who receive adjuvant chemotherapy by addressing low levels of residual disease."
GI-4000 is a series of four product versions based on the company's proprietary Tarmogen® platform. Each version is an intact, heat-inactivated S. cerevisiae yeast expressing a unique combination of three Ras mutations, collectively targeting seven of the most common Ras mutations observed in human cancers. GI-4000 has been generally well tolerated in clinical trials to date. GI-4000-02 is a Phase 2b randomized, double-blind, active-controlled, multi-center clinical trial of GI-4000 in 176 subjects with Ras-mutated resected pancreas cancer. Following resection, subjects were prospectively stratified into two groups by resection status as either an R1 or R0 resection. Subjects received either GI-4000 plus gemcitabine, or placebo plus gemcitabine, following surgical resection of their tumor. For the trial, a sample of tumor tissue was obtained from each subject during the screening period and evaluated for the presence of a Ras mutation. Only the GI-4000 Tarmogen containing a matching mutation in the subject's specific tumor was administered. GI-4000 is also being studied in two ongoing investigator-sponsored Phase 2a trials in subjects with Ras mutation positive non-small cell lung cancers (NSCLC) and colon cancer.
GlobeImmune is a biopharmaceutical company focused on developing therapeutic products for cancer and infectious diseases based on its proprietary Tarmogen platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines, which stimulate predominately antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture. In May 2009, the company entered into a collaboration agreement with Celgene Corporation focused on the discovery, development and commercialization of product candidates for the treatment of cancer. In October 2011, the company entered into a worldwide, strategic collaboration with Gilead Sciences, Inc., to develop Tarmogens for the treatment of chronic hepatitis B infection. For additional information, please visit the company's website at www.globeimmune.com.
Safe Harbor Statement
This press release and the anticipated presentation may contain "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential for the Company's product candidates to target pancreas cancer, NSCLC and colon cancer, the Company's ability to successfully complete clinical trials, timing and eventual prospects for approval to market any of the Company's products and the prospects for the Company's collaborations. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by the Company's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. The Company disclaims any intent or obligation to update these forward-looking statements.
Lena Evans or Tony Russo, Ph.D.
Russo Partners LLC
T: 212-845-4262 or 212-845-4251
David Apelian, M.D., Ph.D.
Chief Medical Officer
1450 Infinite Drive
Louisville CO 80027
Posted: June 2012