About GlobeImmune
GlobeImmune is a biopharmaceutical company focused on developing products for the treatment of 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 that predominately stimulate 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.

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GI-6207-02 is a randomized Phase 2 study that is planned to enroll a total of 34 patients in a cross-over trial design.  Patients will be treated with either GI-6207 for one year or be observed for six months and then treated with GI-6207 for one year.  The primary endpoint for the trial will be the effect of GI-6207 on changes in calcitonin levels after six months of GI-6207 treatment vs. observation.  Calcitonin is a tumor marker that correlates with tumor size in MTC.  Elevated calcitonin values after surgery indicate persistent or recurrent disease.

“We believe that MTC is an excellent clinical indication for Tarmogen^® immunotherapy,” said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. “Observation is the current standard of care for minimally symptomatic MTC with low tumor burden.  However, in this setting we believe we will be able to evaluate GI-6207-induced immune responses and potentially correlate them with calcitonin levels in a short time frame.”

Medullary Thyroid Cancer

Thyroid cancer is the most common type of endocrine malignancy in the U.S. with approximately 56,000 new cases in 2012.  MTC, a subtype of thyroid cancer, is aggressive, spreads quickly and has a poor prognosis, with approximately 25 percent and 10 percent of patients alive at five and ten years, respectively.  Surgery is currently the only curative treatment for MTC.  Two drugs have been approved for the treatment of metastatic MTC.  Both of these products were approved on the basis of improved progression free survival; neither has yet shown improved overall survival.  Both of these products have significant side effect profiles that include hypertension, nausea, diarrhea, cardiac arrhythmias and thrombotic or bleeding episodes.

GI-6207

The GI-6207 Tarmogen consists of whole, heat-killed, recombinant S. cerevisiae yeast genetically engineered to express a modified version of the human carcinoembryonic antigen (CEA) protein as the target cancer antigen.  CEA is over-expressed in multiple human epithelial cancers, including MTC, where CEA is almost universally expressed and is a diagnostic marker of the disease.  Preclinical studies have shown that GI-6207 can induce an immune response to CEA as well as therapeutic anti-tumor responses.  A previous Phase 1 study of monotherapy GI-6207 demonstrated preliminary safety and tolerability, enhanced immune responses and stable disease in 20% of subjects (5/25) beyond 3 months.

About GlobeImmune

GlobeImmune is a biopharmaceutical company focused on developing products for the treatment of 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 that predominately stimulate 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.

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Safe Harbor Statement

This press release contains “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 GI-6207 to target medullary thyroid cancers expressing CEA and Tarmogen’s potential side effect profiles, 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.

The GI-13020-01 Phase 1a clinical trial is a randomized, open-label, dose escalation trial assessing the safety, tolerability and immunogenicity of various doses of GI-13020 in healthy adults.  This study is designed to enroll 48 evaluable subjects at a single U.S.center.

“While approved anti-viral drugs have been shown to effectively suppress replication of the hepatitis B virus, they rarely result in cures and must be taken indefinitely,” said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. “GI-13020 is designed to activate an antigen-specific immune response against HBV, and our development strategy will be to combine GI-13020 with direct-acting antiviral medicines to determine if the combination can increase rates of surface antigen seroconversion, thereby leading to a cure for infected patients.”

HBV infection is the most common form of chronic viral hepatitis in the world.  Approximately 350 million people worldwide are chronic carriers of HBV, resulting in more than 620,000 deaths annually from liver-related diseases.   In theUnited States, chronic HBV infection affects up to 1.4 million people.  Current treatment for HBV includes once-daily oral antiviral therapy medicines to suppress virus replication. These antiviral products have been effective in controlling the disease but generally do not result in a long-term cure, thus requiring chronic suppressive therapy.

About GlobeImmune

GlobeImmune is a biopharmaceutical company focused on developing products for the treatment of 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 that predominately stimulate 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  contains “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 GI-13020 to target HBV and potentially cure an infection, 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.

BOSTON, Nov. 11, 2012 – GlobeImmune, Inc., today announced Phase 2b clinical data showing that GI-5005, a Tarmogen^® product candidate for the treatment of chronic hepatitis C virus (HCV) infection, improved virologic clearance of HCV in combination with pegylated-interferon plus ribavirin (P/R) in genotype 1, IL28B T/T patients.  IL28B T/T is an unfavorable patient genotype that predicts poor sustained virologic response (SVR24) to P/R.

GI-5005-02 is a randomized Phase 2b clinical trial evaluating GI-5005 plus P/R compared to P/R alone in subjects with chronic genotype 1 HCV infection.  Preliminary data from the trial showed that the largest improvement in SVR24 was observed in subjects with the most difficult-to-treat IL28B T/T genotype. GI-5005 enhanced HCV-specific cellular immunity and improved SVR24 [GI-5005+P/R: 3/5 (60%) compared to P/R alone: 0/5 (0%)].

Following this result, the trial was expanded to enroll and treat an additional 17 genotype 1, treatment-naïve subjects having the IL28B T/T genotype.  In the study, presented by Dr. M. L. Shiffman, the Liver Institute of Virginia, Bon Secours Virginia Health System, Newport News, VA, GI-5005 in combination with P/R was well tolerated and had a higher end of treatment virologic response rate [GI-5005+P/R; 10/16 (63%) compared to P/R alone; 3/11 (27%)].

“GI-5005 in combination with pegylated interferon + ribavirin appears to have an effect in the most difficult-to-treat IL28B patients,” said Dr. Shiffman. “GI-5005 could potentially be used in treatment refractory HCV patient subgroups in future regimens.”

GI-5005 contains a fusion of two hepatitis C proteins, NS3 and Core, which are highly conserved across HCV genotypes and are recognized by T cells. GI-5005 is engineered to activate an HCV-specific T cell immune response, resulting in the reduction of cells containing viral antigens.

The World Health Organization estimates that up to 170 million people globally are infected with HCV, with three to four million new infections each year. Approximately 20% to 30% of all HCV patients will face life-threatening complications as a result of their disease. In industrialized countries, HCV accounts for 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma and 30% of liver transplants.

About GlobeImmune

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.

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BOSTON, Nov. 10, 2012 – GlobeImmune, Inc. today announced that GI-13020, an investigational therapeutic vaccine designed using the company’s proprietary Tarmogen^® product platform for the treatment of chronic hepatitis B virus (HBV) infection, demonstrated immunogenicity in two preclinical studies.  GI-13020, which is being developed in collaboration with Gilead Sciences, Inc., was found to activate antigen-specific CD4 and CD8 T cells, including those that respond to the HBV X, S and Core antigens, which are critical for the development of hepatitis B disease. These data will be presented today at The Liver Meeting 2012 in Boston.

A poster by Guo et al. will include data demonstrating antigen-specific T cell responses generated in mice immunized with GI-13020.  In addition, the data will show that GI-13020 significantly protected mice from tumors engineered to express HBV antigens.  In a second poster by Kemmler et al., Tarmogens elicited HBV-specific T cell responses ex vivo in samples collected from healthy individuals and donors with chronic HBV.  Further analyses showed that the Tarmogens were able to elicit functional immune responses in a clinically relevant model.

“Chronic HBV infection, which is characterized by inadequate and dysfunctional T cell responses against HBV antigens, can be effectively suppressed with long term antiviral therapy. However, there is a significant opportunity to improve permanent cure rates,” said David Apelian, M.D., Ph.D., Senior Vice President, Research & Development, and Chief Medical Officer of GlobeImmune. “We believe that administration of GI-13020 in patients whose disease is under virologic control with a direct acting antiviral agent may have the potential to increase hepatitis B surface antigen seroconversion rates, thus potentially allowing discontinuation of antiviral treatment.”

HBV infection is the most common chronic viral hepatitis infection in the world.  Approximately 350 million people worldwide are chronic carriers of HBV, of whom more than 620,000 die from liver-related disease annually. In theUnited States, chronic HBV infection affects up to two million people. Current treatment for HBV includes oral antiviral therapy with once-daily medicines to suppress virus replication. These antiviral products have been highly effective in controlling the disease but generally do not result in a long-term cure, thus requiring chronic suppressive therapy to control the disease.

About GlobeImmune

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.

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Wells Fargo Securities, LLC, and Piper Jaffray & Co. will act as joint book-running managers for the offering. JMP Securities LLC will act as co-manager.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to the offering may be obtained from:

Wells Fargo Securities, LLC
Attention: Equity Syndicate Department
375 Park Avenue
New York, New York 10152
Toll-free: (800) 326-5897
Email: cmclientsupport@wellsfargo.com

Piper Jaffray & Co.
Address: 800 Nicollet Mall, J12S03
Minneapolis, MN 55402
Toll-free: (800) 747-3924
Email: prospectus@pjc.com

About GlobeImmune
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.

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) 14^th 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.

About GlobeImmune

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.

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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.

GI-4000, a series of four product versions based on the company’s proprietary Tarmogen^® platform, targets cancers expressing mutations in the Ras protein. Each version of GI-4000 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-4000-02 is a fully enrolled, Phase 2b randomized, double-blind, placebo-controlled, multi-center adjuvant clinical trial of GI-4000 in subjects with Ras-mutated resected pancreas cancer.   In this study, subjects received either GI-4000 plus gemcitabine, or placebo plus gemcitabine, as adjuvant therapy 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 specific GI-4000 Tarmogen containing a matching mutation in the subject’s tumor was administered.  The study population consists of 176 subjects enrolled at 39 centers in the United States and five international centers between June 2006 and May 2010.  The primary endpoint for this clinical trial is recurrence free survival.

Following resection, subjects were prospectively stratified into two groups by resection status as either an R1 or R0 resection.  An R0 resection is defined by the absence of microscopic residual disease at the surgical margin.  An R1 resection is defined by the presence of microscopic residual disease at the surgical margin.  R0 and R1 patients have different expected survival rates, with R0 patients living longer on average.  At this scientific congress, initial survival data for the R1 subjects will be presented.

GlobeImmune estimates that Ras mutations are found in approximately 180,000 new cancer cases each year in the United States across a spectrum of tumor types, including pancreas, non-small cell lung cancer, colorectal, endometrial and ovarian cancers as well as melanoma and multiple myeloma.  Studies have shown that tumors with Ras mutations can be resistant to conventional chemotherapy as well as approved targeted agents. However, there are no approved products that are specifically directed towards Ras mutations.

About GlobeImmune

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, 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; 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.

GlobeImmune Contact:
David Apelian, M.D., Ph.D., M.B.A.
Chief Medical Officer
T: 303-625-2820
information@globeimmune.com

GlobeImmune Media Contacts:
Lena Evans or Tony Russo, Ph.D.
Russo Partners, LLC
T: 212-845-4262 or 212-845-4251
lena.evans@russopartnersllc.com
tony.russo@russopartnersllc.com