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GlobeImmune’s Hepatitis C Product Candidate Improves End of Treatment Response in All IL-28 B Genotypes, with the Greatest Effect in the Hardest-to-Treat Patients

GlobeImmune GI-5005 HCV Product Candidate Improves Sustained Virologic Response by 10 Percent, Demonstrating Potential to be First Therapeutic Vaccine for HCV

GlobeImmune Announces Presentations of GI-5005 Phase 2b Data at EASL 2010 Meeting


Publications

NOTE:  For optimal resolution, posters should be printed on 11x17 paper.
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2010

Ardiani et al.  "Vaccines based on whole recombinant Saccharomyces cerevisiae cells"  FEMS Yeast Res; (2010) 1-10.

Timcheva et al.  "A Randomized  Phase 2 Adjuvant Trial of Ras Positive Resected Pancreas Cancer Patients Treated with GI-4000 and Gemcitabine or Gemcitabine Alone:  A safety Analysis of the First 100 Treated patients"  Poster presentation; ESMO July 3, 2010.

Whiting et al.  "Trials in Progress: A Randomized, Placebo Controlled, Multicenter Phase 2 Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000 Plus Gemcitabine versus Gemcitabine alone in Patients with Resected Pancreas Cancer with Activating Ras Mutations"  Poster presentation; ASCO June 7, 2010.

McHutchison et al.  "Pharmacogenomic Analysis Reveals Improved Virologic Response in All IL-28 B Genotypes in Naive Genotype 1 HCV Patients treated with GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin"  Poster presentation; EASL April 17, 2010.

Jacobson et al.  "GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Significantly Improves Virologic Response and ALT Normalization at End-of-Treatment and Improves SVR24 Compared to PEG-IFN/ribavirin in Genotype-1 Chronic HCV Patients"  Poster presentation; EASL April 15, 2010.

McHutchison et al.  "GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves Biopsy Necro-Inflammatory Scores and ALT Normalization at 48 weeks Versus PEG-IFN/ribavirin in Genotype-1 Chronic HCV Patients" Poster presentation; EASL April 15, 2010.

Richards et al.A Randomized Phase 2 Adjuvant Trial of Resected Subjects with Ras Mutation Bearing Pancreas Cancer Treated with GI -4000 and Gemcitabine or Gemcitabine Alone: A Safety Analysis of the First 100 Treated Subjects” Poster presentation; ASCO-GI January 20, 2010.

2009

McHutchison et al.  "GI-5005 Therapeutic Vaccine Plus Peg-IFN/Ribavirin Improves End of Treatment Response at 48 Weeks Versus Peg-IFN/Ribavirin in Naïve Genotype 1 Chronic HCV Patients"  Poster presentation; AASLD November 2, 2009.

Boehm et al.  "Concurrent vaccination with two distinct vaccine platforms targeting the same antigen generates phenotyically and functionally distinct T-cell populations." Can Immunol Immunother,  August 2009.

Lawitz et al.  "GI-5005 Immunotherapy Plus PEG-IFN/Ribavirin Versus PEG-IFN/Ribavirin in Genotype 1 Chronic HCV Subjects; Preliminary Phase 2 EVR Analyses"    Poster presentation; EASL April 24, 2009.

Boehm et al.  "Concurrent Vaccination with Two Distinct Vaccine Platforms Targeting the Same Antigen Generates Phenotyically and Functionally Distinct T-cell Populations."  Poster Presentation; AACR April 23, 2009.

Gamerio et al.  "Chemotherapy Can Enhance the Therapeutic Potential of Vaccine-Mediated Immunotherapy."  Poster Presentation; AACR April 23, 2009.

Britton et al.   "Prospective use of an optimized ras mutation diagnostic in an adjuvant Phase 2 trial of mutation specific Ras-targeted immunotherapy (GI-4000) in pancreas cancer"  Poster presentation; AACR April 21, 2009.

2008

McHutchison et al.  "GI-5005 Immunotherapy Plus Peg-IFN/Ribavirin In Genotype 1 Chronic Hepatitis C Patients Compared To Peg-IFN/Ri bavirin Alone In Naive and Non-Responder Patients; Preliminary RVR and Viral Kinetic Analysis From the GI-5005-02 Phase 2 Study"  Poster presentation; AASLD November 3, 2008.

Franzusoff et al.  "Prevalence of K-Ras mutations in pancreas cancer and development of Ras-targeted immunotherapy"  Poster presentation; EORTC-AACR-NCI October 21, 2008.

Guo et al.  "Transnational Patterns of Pancreas Cancer Ras Mutations and Discovery of a New Ras Mutation with Oncogenic Synergy when Found with Ras Codon 12 Mutations"  Poster presentation; AACR-NCI-EORTC, July 22, 2008.

Wansley et al.  "Vaccination with a Recombinant Saccharomyces cerevisiae Expressing a Tumor Antigen Breaks Immune Tolerance and Elicits Therapeutic Antitumor Responses" Clinical Cancer Research. July 2008.

Munson et al. "Coupling Innate and Adaptive Immunity with Yeast-Based Cancer Immunotherapy"  Chapter 9; Cancer Vaccines and Tumor Immunity. January 2008.

Haller et al.. "Therapeutic and Prophylactic Viral Immunity in Animals and Humans."  Oral and Poster Presentation; Viral Immunity Conference, Keystone Symposia January 21, 2008.

Bernstein et al.. "Recombinant Saccharomyces cerevisiae (yeast-CEA) as a potent activator of murine dendritic cells."  Vaccine (2008) 26, 509-521.

2007

Schiff et al. "HCV-Specific Cellular Immunity, RNA Reductions, and Normalization of ALT in Chronic HCV Subjects after Treatment with GI-5005, a Yeast-Based Immunotherapy Targeting NS3 and Core: A Randomized, Double-blind, Placebo Controlled Phase 1b Study."  Poster presentation; AASLD, November 6, 2007, Boston MA.

Wansley et al. "Vaccination of CEA-transgenic mice with a recombinant Saccharomyces cerevisiae-CEA vaccine breaks immune tolerance and elicits therapeutic antitumor responses."  Poster presentation; AACR-NCI-EORTC, October 25, 2007, San Francisco, CA.

Remondo et al. "Recombinant yeast (Saccharomyces cerevisiae) vector encoding carcinoembryonic antigen (CEA) activates human dendritic cells for CEA-specific T-cell reponses."  Poster presentation; AACR-NCI-EORTC, October 25, 2007, San Francisco, CA.

DeGregori et al. "Control of leukemia driven by the T315I escape mutation in Bc r-Abl with yeast-based Tarmogen immunotherapy."   Poster presentation; AACR-NCI-EORTC, October 25, 2007, San Francisco, CA.

Reimann et al. "Generation of a prophylactic melanoma vaccine using whole recombinant yeast expressing MART-1"  Experimental Dermatology 2007; 16: 814-822.

Guo et al. "Oncogenic synergy and a newly identified transforming ras mutation in human cancer" American Association for Cancer Research (AACR) 2007.  Poster Presentation, Abstract LB-345; Los Angeles CA.

Haller et al. "Whole recombinant yeast-based immunotherapy induces potent T cell responses targeting HCV NS3 and Core proteins" Vaccine (2007) 25, 1452-1463."

2006

Everson et al. "Interim Results from a Randomized, Double-Blind, Placebo-Controlled Phase 1b Study in Subjects with Chronic HCV After Treatment with GI-5005, a Yeast-based HCV Immunotherapy Targeting NS3 and Core Proteins." American Association for the Study of Liver Disease (AASLD) 2006.   Poster Presentation, October 30, 2006, Boston MA.

Franzusoff et al. "Yeast-based Tarmogen Immunotherapy Against Brain Tumors Expressing Self Antigens." American Association for Cancer Research (AACR).   Poster Presentation, April 2, 2006, Washington DC.

Haller et al. "Targeting Influenza with Yeast-Based Immunotherapy". Keystone Symposia: Advances in Influenza Research: From Birds to Bench to Bedside Poster Presentation, March 29, 2006, Steamboat CO.

Whiting et al."Treatment of Ras mutation-bearing solid tumors using whole recombinant S. cerevisiae yeast expressing mutated Ras:  preliminary safety and immunogenicity results from a Phase 1 trial".  ASCO Gastrointestinal Cancers Symposium.  Poster Presentation,  January 27, 2006, San Francisco CA.

2005

Haller et al. "Yeast Based Tarmogen Immunotherapy for Chronic HCV Infection"  12th International Symposium on Hepatitis C and Related Viruses,  Poster Presentation; October 2-6, 2005, Montreal Canada.

Cohn et al. "Treatment of Ras mutation-bearing solid tumors using whole recombinant S. cerevisiae yeast expressing mutated Ras:  preliminary safety and immunogenicity results from a Phase 1 trial."ASCO 2005.  Poster Presentation (Abstract 2571); Sunday May 15, 2005; Orlando FL. 

Haller et al. "Preclinical Development of Yeast-Based Immunotherapy for Chronic Hepatitis Virus Infection."  8th Annual Conference on Vaccine Research.  Poster Presentation; May 9-11, 2005; Baltimore MD.

Franzusoff et al. "Yeast encoding tumor antigens in cancer immunotherapy."  (2005) Expert Opinion in Biological Therapy.  5(4); 565-575.

Fujita et al. "Whole recombinant yeast immunotherapeutic vaccine expressing human MART1 elicits protection against melanoma." Keystone Symposia: Basic Aspects of Tumor Immunology II.  Poster Presentation; March 19, 2005; Keystone CO.

Haller et al. "A Novel Yeast-based Immunotherapeutic for Chronic Hepatitis C Virus Infection" AASLD Single Topic Conference, Poster Presentation; March 4 2005, Chicago IL.

2004

Fujita et al. "Whole recombinant yeast immunotherapeutic protection against melanoma." Cancer Vaccines 2004.  Poster Presentation; October 5, 2004; New York NY.

Lu et al. "Mutation-selective tumor remission with ras-targeted, whole yeast-based immunotherapy."  (2004) Cancer Research 64, 5084-5088.

2001

Simpson.  "Rising to the vaccine challenge." (2001) Science 292, Number 5592, 1613.

Stubbs et al. "Whole recombinant yeast vaccine activates dendritic cells and elicits protective cell-mediated immunity."  (2001) Nature Medicine 7, 625-629




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