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GlobeImmune Announces Presentation of GI-4000 Phase 2 Data at IASLC World Conference on Lung Cancer


October 27, 2013 - London

Sydney, Australia, October 28, 2013GlobeImmune, Inc. announced that data from a Phase 2 clinical trial of the GI-4000 Tarmogen® in patients with non-small cell lung cancer (NSCLC) will be presented today at the International Association for the Study of Lung Cancer (IASLC) 15th World Conference on Lung Cancer in Sydney, Australia.The study evaluated GI-4000 as consolidation therapy in patients with  tumors with mutations in K-Ras following treatment with curative intent for Stage I-III NSCLC.The study was performed at Memorial Sloan Kettering Cancer Center (MSKCC) in New York.  

In this study, 24 patients with Stage I-III, K-Ras mutant+ NSCLC who successfully completed first-line treatment were enrolled in the study.Additionally, 64 case-matched, contemporary control patients were followed at MSKCC.GI-4000-treated patients demonstrated a trend for improved 1-, 2- and 3-year survival over the case-matched controls.

Overall Survival GI-4000 Control
Year 1 100% 93%
Year 2 100% 88%
Year 3 92% 83%
HR = 0.58; p=0.29

Dr. Jamie Chaft of MSKCC, the lead author of the abstract, will present the results during an oral session at 4:15 p.m. today in the Bayside Gallery B auditorium.The abstract (#2451) titled, "Phase 2 study of the GI-4000 Kras vaccine following curative therapy in patients with Stage I-III lung adenocarcinoma harboring a Kras G12C, G12D, G12V or G12R mutation," is published online at the IASLC web site.  

"Despite multi-modality treatment with curative intent, most patients with early-stage lung cancers recur and die of their disease," said Dr. Chaft.  "The most frequent acquired genetic cause of non-small cell lung cancers is mutation in a gene called K-ras.  Unfortunately, unlike their less common counterparts, K-Ras-mutant lung cancers have no standard targeted treatment options available.  Better treatments designed specifically for patients with K-Ras-mutant lung cancers are an unmet need in lung cancer care."

About GI-4000

GI-4000 is a series of Tarmogen products intended to generate a T cell immune response in patients against cells containing Ras mutations. Mutations in K-Ras are believed to be responsible for over 180,000 cases of cancer annually in the United States, including significant proportions of pancreas, NSCLC, colorectal, ovarian and other cancers.

About NSCLC

lung cancer remains the leading cause of cancer in the United States, with 228,190 new cases and 159,480 deaths estimated to occur in 2013. Non-small cell lung cancer accounts for approximately 85% (194,000) of all lung cancers.Approximately 25% of NSCLC tumors harbor a Ras mutation and appear to be resistant to chemotherapy and targeted therapies, offering patients fewer treatment options.  For more information on NSCLC, please see the American Cancer Society website.

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 Tarmogens to target NSCLC, Tarmogen 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. 

GLOBEIMMUNE CONTACT:
Timothy C. Rodell M.D.
President and Chief Executive 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 

GLOBEIMMUNE INVESTOR CONTACT:
Susan Noonan
S.A. Noonan Communications
T: 917-513-5303
susan@sanonan.com





This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the
information contained therein.

Source: GlobeImmune, Inc via Thomson Reuters ONE

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