LOUISVILLE, Colo., 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.

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 & 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.

Gilead Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to the development and commercialization of therapeutic vaccines for the treatment of chronic HBV infection.  Further, there are risks related to clinical trials of therapeutic vaccines under the collaboration, including the ability to enroll sufficient patients, the possibility of unfavorable results, the need to modify or delay the studies or to perform additional trials and the risk of failing to obtain approvals from the regulatory authorities.  As a result, therapeutic vaccines under the collaboration may never be successfully commercialized.  In addition, Gilead and GlobeImmune may make a strategic decision to terminate the collaboration or discontinue development of certain therapeutic vaccines under the collaboration.  These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.  The reader is cautioned not to rely on these forward-looking statements.  These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed with the U.S. Securities and Exchange Commission.  All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

#  #  #

 Viread is a registered trademark of Gilead Sciences, Inc. 

 Tarmogen is a registered trademark of GlobeImmune, Inc.

Before joining GlobeImmune, Mr. Dekker held leadership positions in finance and accounting at private software companies since 1993, including posts ranging from Corporate Controller to Vice President at Webroot Software Inc., Requisite Technology Inc. and NxTrend Technology Inc.   Earlier in his career, Mr. Dekker worked at ITT Rayonier Port Angeles Pulp Division and at KPMG in Los Angeles.  He earned a B.S. in accounting from Utah State University and is a certified public accountant.

About GlobeImmune

GlobeImmune Inc. is a private company developing therapeutic vaccines called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally infected cells.  The company’s lead infectious disease product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV).  The company’s lead oncology programs, GI-4000 and GI-6207, target cancers caused by mutated versions of the Ras oncoprotein and CEA expressing tumors, respectively. GI-4000 is being investigated in clinical trials for the treatment of cancers expressing mutated Ras, including non-small cell lung cancer, pancreatic cancer and colorectal cancer. GI-6207 is being evaluated in clinical trials in patients with CEA expressing tumors.  In July 2008, GlobeImmune signed a Cooperative Research and Development Agreement (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.

GI-6207 monotherapy results in stable disease in 20% of patients and good tolerability in patients with CEA-expressing metastatic tumors

Data to be presented at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO)

Louisville, Colo, June 1, 2011 – GlobeImmune Inc. today presented safety and immunogenicity data from two clinical studies of therapeutic vaccines based on the Company’s Tarmogen^® technology.  In the first study, GI-4000, a series of Tarmogen^® products engineered to express the seven most common KRAS mutations, was administered as consolidation of first line therapy to patients with stage I-III lung adenocarcinoma having a matching KRAS mutation in their tumor. GI-4000 demonstrated good tolerability and disease-specific immune responses in this phase 1 trial.  GI-6207, a Tarmogen expressing human CEA, was tested as a monotherapy in patients with treatment refractory stage IV, CEA expressing cancers.  GI-6207 showed good tolerability and stable disease by RECIST for 3 months or longer in 20% of patients in this phase 1/2a trial.

“We are very encouraged by the results of these studies showing that GI-4000 and GI-6207 were both well tolerated and appeared to be active against the diseases studied,” said Dr. David Apelian, Chief Medical Officer of GlobeImmune. “These studies provide evidence that our Tarmogen^® technology is a promising method for inducing an immunologic anti-tumor response. Based on these data, we are designing Phase 2 studies to specifically develop these products for a variety of different clinical indications.”

Abstract No. 7070 presented by Sandra P. D’Angelo M.D. / Memorial Sloan Kettering Cancer Center

GI-4000 is a series of four Tarmogens that express the seven most common mutant KRAS oncoproteins. This Phase 2a study enrolled 24 patients with tumors expressing KRAS mutations contained in the product. GI-4000 was administered to patients with stage I-III non-small cell lung cancer (NSCLC) as consolidation therapy after successful first line treatment.  GI-4000 was administered weekly for three doses, then monthly for six doses, then every three months for up to three years. The primary endpoints for the trial were safety and immunogenicity.  Patients received a median of nine doses. No serious adverse events were reported. A disease-specific immune response was induced in 47% (8/17) of patients with sufficient immune sampling for analysis. Fifty five percent (5/9) of patients developed a treatment-emergent response, and 37% (3/8) showed an improvement in pre-existing baseline response.  

Abstract No. 2604 presented by Ravi A. Madan M.D. / National Institutes of Health

GI-6207 is a Tarmogen designed to elicit a T cell immune response in patients against cancers that express carcinoembryonic antigen (CEA).  CEA is over-expressed in >90% of colorectal, gastric and pancreas cancers, 70% of NSCLC and 50% of breast cancer.  This single-center Phase 1 study enrolled 25 patients at three dose levels, 4YU, 16YU, and 40YU (1 YU or yeast unit = 10 million cells). The product was administered subcutaneously at four sites bi-weekly for three months then monthly until disease progression. Safety and immunogenicity were evaluated.  The most common adverse event was a grade 1/2 injection site reaction.  Immune response analysis is ongoing.  Five of the 25 (20%) evaluable patients had stable disease beyond three months and two are ongoing.  Each of these patients had stabilization or declines in serum CEA levels.

About GlobeImmune

GlobeImmune Inc. is a private company developing therapeutic vaccines called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells.  The Company’s lead infectious disease product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV).  The Company’s lead oncology programs, GI-4000 and GI-6207, target cancers caused by mutated versions of the Ras oncoprotein and CEA expressing tumors respectively. GI-4000 is being investigated in clinical trials for the treatment of cancers expressing mutated Ras, including non-small cell lung cancer, pancreatic cancer, and colorectal cancer. GI-6207 is being evaluated in clinical trials in patients with CEA expressing tumors.  In July, 2008 GlobeImmune signed a Cooperative Research and Development Agreement (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.

For additional information, please visit the company’s website at www.globeimmune.com.

This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company’s clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.

• GI-5005, GlobeImmune’s most advanced product candidate, is a therapeutic vaccine for the treatment of chronic hepatitis C virus (HCV) infection. Phase 2b clinical trials have demonstrated that when added to standard of care (SOC, pegylated interferon-alfa2a and ribavirin), GI-5005 improves sustained virologic response (SVR, or “cure”) by 10% in treatment-naïve patients and 12% in prior non-responders compared to patients receiving SOC alone. Additionally, GI-5005 has been shown to increase SVR by 60% in patients with the IL28B T/T genotype, a patient group with the highest rate of treatment failure on SOC.
• GI-4000 targets cancers caused by mutations in the Ras oncogene product. The GI-4000 therapeutic vaccine is currently in Phase 2b clinical trials in patients with pancreas cancer, non-small cell lung cancer and colorectal cancer.
• GI-6207 is for the treatment of cancers that over-express carcinoembryonic antigen (CEA). This therapeutic vaccine is currently being evaluated in a Phase 1 clinical trial in patients with non-small cell lung cancer.

About GlobeImmune
GlobeImmune Inc. is a private company developing therapeutic vaccines called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells. The Company’s lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). GI- 5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company’s lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. 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.

For additional information, please visit the company’s website at www.globeimmune.com.

This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company’s clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.

GLOBEIMMUNE CONTACT:
Jeffrey Rona
Chief Business Officer
GlobeImmune
T: 303-625-2820
information@globeimmune.com

MEDIA CONTACT:
Heidi Chokeir, Ph.D.
Russo Partners
T: 619-528-2217
M: 858-380-6584
heidi.chokeir@russopartnersllc.com

Data to be presented at annual meeting of the American Association for the Study of the Liver Disease

LOUISVILLE, Colo., October 30, 2010 — GlobeImmune Inc. today announced additional data from the GI-5005-02 Phase 2b study demonstrating that GI-5005, the Company’s investigational Tarmogen® product, improved sustained virologic response (SVR) by 12% in patients with genotype 1 chronic hepatitis C virus (HCV) infection who had failed prior treatment with standard of care (SOC, pegylated-interferon alpha 2a plus ribavirin). This study suggests that GI-5005 may have the potential to be the first successful therapeutic vaccine for patients chronically infected with HCV.

Paul J. Pockros, M.D., of Scripps Clinic will deliver the oral presentation of the results in a late-breaker session at 6 p.m. EDT today at the 61st Annual Meeting of the American Association for the Study of the Liver (AASLD) in Boston.

On an intent-to-treat basis (subjects who received at least one dose of combination therapy), prior non-responders receiving GI-5005 plus SOC as a triple therapy had an SVR rate of 17%, compared to an SVR rate of only 5% in patients receiving SOC alone. Prior non-responders in this study were defined as patients who did not clear virus after a minimum of 12 weeks of SOC, including null responders, poor responders, and partial responders. Relapsers and on-treatment breakthroughs were not enrolled in the study.  The most common adverse events associated with GI-5005 were injection site reactions that were generally mild and transient in nature.  Discontinuation rates due to adverse events in the GI-5005 triple therapy arm were comparable to the discontinuation rates in the SOC alone arm.

“Only 4-7% of patients with genotype 1 HCV who were null, poor or partial responders to their first course of pegylated interferon-based therapy would be expected to achieve a sustained virologic response with a second course of treatment,” said Dr. Pockros. “In this study, GI-5005 conferred a three-fold improvement in SVR, an important treatment effect in this challenging patient population.”

Additional immunology data from the study will be presented in a poster on Tuesday November 2, 2010 by John M. Vierling, M.D., of Baylor College of Medicine. These data show that GI-5005 improved HCV-specific T cell responses 10-fold over SOC alone in patients with the IL28B T/T genotype (~20% of chronically infected patients), the subgroup most likely to fail treatment with SOC alone. Patients with the IL28B T/T genotype receiving SOC alone had an HCV-specific cellular immune response that was 17-fold lower than patients in the IL28B C/C or C/T subgroups. The improved HCV-specific T cell immunity in IL28B T/T patients receiving GI-5005 plus SOC correlates with previously reported data that demonstrated GI-5005 increased SVR rates by 60 percent in interferon-naïve T/T patients compared to T/T patients receiving SOC alone.

“These data suggest that the fundamental deficit in patients carrying the T allele of the IL28B gene is a deficit in adaptive cellular immunity, the mechanism that GI-5005 was designed to address,” said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. “We are confident that GI-5005 will become a cornerstone of HCV therapy, particularly for difficult to treat populations, such as IL28B T/T patients.”

A 40 patient expansion of this study in patients having the IL28B T/T genotype was initiated last week to further explore the potential treatment effect of GI-5005 in this patient population.

GI-5005 is a therapeutic vaccine candidate designed to generate HCV-specific T-cell responses and improve virologic responses in patients with chronic hepatitis C virus infection.

About GlobeImmune

GlobeImmune Inc. is a private company developing therapeutic vaccines called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate virally-infected cells and/or cancer cells.  The Company’s lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C virus (HCV) infection. GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company’s lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein.  GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. 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.

This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company’s clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.

GLOBEIMMUNE CONTACT:
David Apelian, M.D.
Chief Medical Officer
T: 303-625-2820
information@globeimmune.com

MEDIA CONTACT:
Heidi Chokeir, Ph.D.
Russo Partners
T: 619-528-2217
M: 858-380-6584
heidi.chokeir@russopartnersllc.com

“HCV patients with the IL28B T/T genotype have a very poor prognosis with current treatment options,” said Timothy C. Rodell, M.D., President and CEO of GlobeImmune.  “We believe that GI-5005 addresses a fundamental deficit in patients carrying the T allele of the IL28B gene by augmenting their deficient T cell immune response against HCV.  Our phase 2 immunology data indicate that a limited T cell immune response is likely why the current standard of care, which acts primarily by inhibiting viral replication, has limited efficacy in this patient group.”

“Patients with the IL28B T/T genotype have the lowest rates of sustained virologic response to today’s standard of care and will very likely continue to have lower response rates and a high rate of anti-viral resistance with the addition of a protease inhibitor,” said Mitchell L. Shiffman, M.D., Director of The Liver Institute of Virginia. “Preliminary data strongly suggest that GI-5005 enhances the ability of a patient with the IL28B T/T genotype to respond to HCV treatment.  This represents the first significant advance in our ability to treat chronic HCV in patients who are genetically less sensitive to interferon.  The expansion of the GlobeImmune program to specifically study patients with the IL28B T/T genotype is an important step for successful treatment of these patients in the future.”

Additional data from the original 140 subjects enrolled in the trial will be presented this week at 61st Annual Meeting of the American Association for the Study of the Liver (AASLD) in Boston.

• Paul J. Pockros, M.D. of Scripps Clinic will deliver an oral presentation of the results from the GI-5005-02 trial in patients previously treated with SOC in a late-breaker session Monday November 1, 2010 at 6 p.m. EDT in the Hynes Auditorium.
• John M. Vierling, M.D. of Baylor College of Medicine will present immune response data in a poster on Tuesday November 2, 2010 Hynes Exhibit Hall C.

The design of the clinical trial expansion is identical to the original GI-5005-02 trial, and will be conducted in approximately 30 of the participating U.S. sites. The primary endpoint of the randomized, open-label expansion study is sustained virologic response (SVR).

Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that are engineered to express one or more disease-related proteins.  GlobeImmune’s GI-5005 Tarmogen is a therapeutic vaccine product candidate that contains conserved HCV proteins and is designed to generate an HCV-specific T-cell response.

About GlobeImmune

GlobeImmune Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells.  The Company’s lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company’s lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein.  GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. 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.

This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company’s clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.

GLOBEIMMUNE CONTACT:
David Apelian, M.D., Ph.D.
Senior Vice President, Research and Development and
Chief Medical Officer
GlobeImmune
T:     303-625-2820
information@globeimmune.com

MEDIA CONTACT:
Heidi Chokeir, Ph.D.
Russo Partners
T:     619-528-2217
M:     858-380-6584
heidi.chokeir@russopartnersllc.com

LOUISVILLE, Colo., October 1, 2010 – GlobeImmune Inc. today announced that an abstract related to GI-5005, its Phase 2 investigational hepatitis C virus (HCV) product candidate, has been accepted for a late breaking oral presentation at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place October 29 through November 2, 2010, in Boston.

At the AASLD annual meeting, GlobeImmune will present end-of-study data, including sustained virologic response (SVR) rate from prior non-responders, from a Phase 2 clinical study investigating the safety and efficacy of GI-5005. The study compared GI-5005 plus peg-interferon (peg-IFN) and ribavirin, the current standard of care (SOC), versus SOC alone in patients with chronic type 1 hepatitis C infection. Prior non-responders were defined as those patients who did not achieve viral negativity by PCR after a minimum of 12 weeks of SOC. Patients that had achieved viral negativity by PCR during prior SOC but had relapsed during or after completion of SOC therapy were excluded from the study.

The abstract, titled “GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves Sustained Virologic Response Versus PEG-INF/Ribavirin in Prior Non-Responders With Genotype 1 Chronic HCV Infection,” is published online at the AASLD Web site.

Dr. Paul J. Pockros of Scripps Clinic is the lead author of the abstract that will be presented as part of a late breaker oral session beginning at 6 p.m. EDT on Monday, November 1, 2010 in the Hynes Auditorium. The presentation will include complete response and sustained virologic response rates for patients who received the GI-5005 plus SOC as well as SOC patients in the control arm of the study.

Additionally, Dr. John M. Vierling of Baylor College of Medicine will present a poster titled “GI-5005 Therapeutic Vaccine Improves Deficit in Cellular Immunity in IL28B Genotype T/T, Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 When Added to Standard of Care PEG-IFN-Alfa- 2A/Ribavirin,” on Tuesday, November 2, 2010 in the Hynes Exhibit Hall C.

GI-5005 is a therapeutic vaccine candidate that the company believes generates HCV specific T-cell responses and improves virologic responses in patients with chronic hepatitis C infection.

About GlobeImmune
GlobeImmune Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells. The Company’s lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). GI- 5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company’s lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. 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.

For additional information, please visit the company’s Web site at www.globeimmune.com.

This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company’s clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.

GLOBEIMMUNE CONTACT:
David Apelian, M.D.
Chief Medical Officer
T: 303-625-2820
information@globeimmune.com

MEDIA CONTACT:
Heidi Chokeir, Ph.D.
Russo Partners
T: 619-528-2217
M: 858-380-6584
heidi.chokeir@russopartnersllc.com

LOUISVILLE, Colo., April 19, 2010 – GlobeImmune Inc. announced Phase 2b data for GI-5005, the Company’s investigational Tarmogen® product for hepatitis C virus (HCV) infection, correlating GI-5005 treatment response rate and IL-28 B genotype in patients with chronic HCV infection.

It was recently reported that variations in the human IL-28 B gene are predictive of spontaneous clearance of HCV infection (Thomas et al, Nature 2009), as well as response to treatment with standard of care, (SOC) pegylated interferon alpha plus ribavirin (Ge et al, Nature 2009). In the IL-28 B T/T genotypes, only a third as many patients respond to SOC as compared to the C/C genotype. The GI-5005 Phase 2b study demonstrated that all IL-28 B genotype subgroups receiving GI-5005 in addition to SOC saw an improvement in viral clearance as measured by PCR at the end of treatment (ETR) compared to patients receiving SOC alone. Patients with the hardest-to-treat T/T genotype in the GI-5005 arm of the study saw the greatest improvement in sustained virologic response (SVR – defined as viral negativity 6 months off treatment and used to define successful treatment), with a 60 percent treatment effect compared to SOC alone. Patients carrying the T allele (form) (C/T or T/T) of the IL-28 B gene are at high risk for treatment failure with SOC and represent approximately 65 percent of the treatment naïve population.

“Differences in the IL-28 B genotype determine how effectively a patient’s immune system responds against the HCV virus,” said John G. McHutchison, M.D., Associate Director of the Duke Clinical Research Institute at Duke University Medical Center, who presented the data on Saturday at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL). “The data from the GI-5005 study are encouraging because there is a significant need for potential new strategies for the hardest to treat IL-28 B genotype patients.”

Genetic analysis of the IL-28 B gene was performed retrospectively on 140 patients with chronic genotype 1 hepatitis C infection who were either treatment naïve or prior non-responders as part of a Phase 2b study comparing GI-5005 plus SOC versus SOC. The data show:

• GI-5005 improved viral clearance as measured by PCR in all IL-28 B genotypes
• 100% (5/5) patients in the GI-5005 arm of the trial with the hardest-to-treat T/T genotype achieved viral negativity on treatment during the study
• 60% (3/5) of T/T genotype patients receiving GI-5005 went on to achieve SVR, compared to 0% (0/5) of patients receiving SOC

“Prior publications on the IL-28 B gene and this study demonstrate the importance of the immune response in HCV treatment,” said David Apelian, M.D., Ph.D., chief medical officer at GlobeImmune. “These data suggest that a critical component of the future of HCV treatment lies in immune-stimulating therapies such as GI-5005.”

Dr. McHutchison and Ira M. Jacobson, M.D., Vincent Astor Distinguished Professor of Medicine at NewYork-Presbyterian/Weill Cornell Medical Center, presented additional data from the Phase 2b study at the conference. The data demonstrated a 10 percent absolute improvement in SVR for treatment-naïve patients receiving GI-5005 plus SOC versus SOC alone. Adding GI-5005 to SOC also resulted in a 67 percent relative improvement in the proportion of patients achieving normalization of ALT levels, and a 39 percent relative improvement in biopsy necroinflammatory scores, both measures of liver damage.

Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that express antigens from one or more disease-related proteins. GlobeImmune’s GI-5005 Tarmogen is a therapeutic vaccine product candidate that contains conserved HCV proteins and is designed to generate an HCV specific T-cell response.

About GlobeImmune

GlobeImmune Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that locate and eliminate cancer cells and/or virally-infected cells. The Company’s lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company’s lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. 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.

For additional information, please visit the company’s Web site at www.globeimmune.com.

This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company’s clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.

LOUISVILLE, Colo., April 15, 2010 – GlobeImmune, Inc. today announced final Phase 2b data for GI-5005, the Company’s investigational Tarmogen® product candidate, demonstrating its potential to be the first successful therapeutic vaccine for chronic hepatitis C virus (HCV) infection. The data show that GI-5005 increased the sustained virologic response (SVR) in genotype 1 interferon-naïve patients to 58 percent when used in combination with standard of care (SOC), pegylated interferon-a2a plus ribavirin, versus 48 percent for patients receiving SOC alone. The study also demonstrated that adding GI-5005 to SOC results in an improvement in normalization of alanine aminotransferase (ALT) levels and suggests an improvement in liver biopsies, both markers used to assess liver damage.

Ira M. Jacobson, M.D., the Vincent Astor Distinguished Professor of Medicine at NewYork-Presbyterian/Weill Cornell Medical Center and John G. McHutchison, M.D., Associate Director of the Duke Clinical Research Institute at Duke University Medical Center, presented the data today at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL).

“This is the first clinical study to demonstrate that a therapeutic vaccine can be used for patients with chronic hepatitis C infection,” said Dr. Jacobson. “With its novel mode of action and apparent safety profile, the GI-5005 therapeutic vaccine could have an important impact on the treatment of this disease.”

The Phase 2b study compared GI-5005 plus SOC versus SOC alone in 140 patients with chronic genotype 1 hepatitis C infection who were either treatment naïve or prior non-responders to SOC. On an intent-to-treat basis (patients having received at least one dose of combination therapy), treatment naïve patients receiving GI-5005 plus SOC as a triple therapy had an SVR rate of 58 percent, compared to an SVR rate of 48 percent in treatment naïve patients receiving SOC alone, a relative improvement of 21 percent. GI-5005 triple therapy demonstrated a 67 percent relative improvement in the proportion of patients achieving normalization of ALT levels on therapy.  ALT is a marker of liver injury that is used to follow liver function in HCV patients.  In addition, a trend toward an improvement in biopsy necroinflammatory scores was seen with a 39 percent relative improvement compared to those receiving SOC alone. The most common adverse events associated with GI-5005 were injection site reactions that were generally mild and transient in nature.  Importantly, GI-5005 did not increase the discontinuation rates due to adverse events when added to standard of care [GI-5005 + SOC - 13.2 percent vs. SOC alone - 12.3 percent].

“These data show that adding GI-5005 to standard of care may give patients a clinically important advantage without added toxicity,” said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. “We believe that this is an important medical breakthrough in the treatment of hepatitis C, and it may have implications for the development of treatments for other chronic viral infections.”

Pharmacogenomic data demonstrating a correlation between GI-5005 treatment effect and polymorphisms in the human IL-28 B gene will also be presented at the EASL meeting on Saturday, April 17 by Dr. McHutchison.

Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that are engineered to express one or more disease-related proteins.  GlobeImmune’s GI-5005 Tarmogen is a therapeutic vaccine product candidate that contains conserved HCV structural proteins and is designed to generate an HCV specific T-cell response.

About GlobeImmune

GlobeImmune, Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that locate and eliminate cancer cells and/or virally-infected cells.  The Company’s lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company’s lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein.  GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. 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.

For additional information, please visit the company’s Web site at www.globeimmune.com.

This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company’s clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.