Publications Archive

NOTE: For optimal resolution, posters should be printed on 11×17 paper.

2015

• Heery et al “GI-6301 Phase 1 trial of a yeast-based therapeutic cancer vaccine (GI-6301) targeting the transcription factor brachyury.”  Cancer Immunonology Research approved for pub 6-25-2015.
• Stacchiotti et al “Building a global consensus approach to chordoma: a position paper from the medical and patient community.”  Lancet Oncol 2015; 16: e71–83.

2014

• Shahda and ONeil “GI-4000 in KRAS mutant cancers” Expert Opinion Investigational Drugs (2014) 23(2):273-278.
• Hartley et al “Pancreatic cancer, treatment options, and GI-4000.” Human Vaccines & Immunotherapeutics 10:11, 3347-3353. November 2014 (although the publication erroneously says 2015 in the header).
• Heery et al “NCI Experience Using Yeast‐brachyury Vaccine (GI‐6301) in Patients with Advanced Chordoma” CTOS Oral Presentation (October 17, 2014).
• Tucker et al ” Identification and characterization of a cytotoxic T‑lymphocyte agonist epitope of brachyury, a transcription factor involved in epithelial to mesenchymal transition and metastasis.” Cancer Immunol Immunother (2014) 63:1307–1317 [Epub available September 2014].
• Chaft et al “Phase II Study of the GI-4000 KRAS Vaccine After Curative Therapy in Patients with Stage I-III Lung Adenocarcinoma Harboring a KRAS G12C, G12D, or G12V Mutation.” Clinical Lung Cancer [epub available 21 June 2014].
• King et al “A Whole Recombinant Yeast-Based Therapeutic Vaccine Elicits HBV X, S and Core Specific T Cells in Mice and Activates Human T Cells Recognizing Epitopes Linked to Viral Clearance.” PLoS ONE 9(7): e101904. 22 July 2014.
• Gaggar et al “Safety, tolerability and immunogenicity of GS-4774, a hepatitis B virus-specific therapeutic vaccine, in healthy subjects: A randomized study.” Vaccine 32 (2014) 4925-4931. 08 July 2014.
• Heery et al “NCI Experience using Yeast-Brachyury Vaccine (GI-6301) in Patients with Advanced Chordoma“” Poster Presentation; ASCO 2014 Annual Meeting (J Clin Oncol 32:5s, 1 June 2014 suppl; abstract 3081).
• Richard et al “Proteomic Signature Predicts Response to a Therapeutic Vaccine in Pancreas Cancer, Analysis of GI-4000-02” Poster Presentation; AACR Annual Meeting (Abstract 5314); 9 April 2014.
• Coeshott et al “Immune Responses to Mutated Ras – Development of a Yeast Based Immunotherapeutic” Poster Presentation; AACR Ras Oncogenes: From Biology to Therapy (Abstract A28); 25 February 2014.
• Ardiani et al “Vaccine-mediated immunotherapy directed against a transcription factor driving the metastatic process” Cancer Res 14(7):1945-57; 11 February 2014.
• Palena, Fernando, Hamilton. “An immunotherapeutic intervention against tumor progression.” Oncoimmunology. Jan 1, 2014; 3(1): e27220.

2013

• Bilusic et al “Phase 1 trial of a recombinant yeast-CEA vaccine (GI-6207) in adults with metastatic CEA-expressing carcinoma” Cancer Immunology Immunotherapy 24 November 2013.
• Gaggar et al “Safety, Tolerability, and Immunogenicity of GS-4774, an HBV-Specific Therapeutic Vaccine, in Healthy Volunteers” Poster presentation; AASLD, November 2013.
• Hamilton et al “Immunological targeting of tumor cells undergoing and epithelial-mesenchymal transition via a recombiant brachyury-yeast vaccine.” Oncotarget, Vol. 4, No 10; October 2013.
• Chaft et al “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.” Oral presentation; IASLC World Conference on Lung Cancer; 28 October 2013.
• Ardiani et al. “Combination Therapy with a Second-Generation Androgen Receptor Antagonist and a Therapeutic Vaccine Targeting a Driver of Metastasis Improves Survival in a Spontaneous Prostate Cancer Model” ClinCanRes 1-14, 2013.
• Fletcher & Delaney. “New Therapeutic Targets and Drugs for the Treatment of Chronic Hepatitis B” Semin Liver Dis (2013) 33:130-137.
• Madan et al. “A Phase 2 study of a yast-based therapeutic vaccine targeting CEA, GI-6207, in patients with asympotmatic metastatic medullary thyroid cancer – NCT01856920” Poster presentation; ASCO, June 3, 2013.
• King et al. “Whole Recombinant Yeast Therapeutic Vaccine Generates HBV X, S, and Core Antigen-Specific Responses in Murine and Human T Cells” Poster presentation; EASL, April 25, 2013.

2012

• Shiffman et al.  ” GI-5005 Therapeutic Vaccine Enhances Virologic Clearance by pegIFN/Ribavirin in Naive HCV Genotype 1 Patients with IL28B Genotype T/T ” Poster presentation; AASLD, November 11, 2012.
• Kemmler et al.  ” Recombinant Yeast Therapeutic Vaccines Expressing (HBV) X, S and Core Antigens Generate Antigen Specific T Cell Responses in Immune Samples from Healthy and Chronic HBV Donors .” Poster presentation; AASLD, November 10, 2012.
• Guo et al.  ” Recombinant Yeast Therapeutic Vaccines Expressing Hepatitis B Virus (HBV X, S and Core Antigens Generate Antigen Specific T Cell Responses and Tumor Portection in Mice. ”  Poster presentation; AASLD, November 10, 2012.
• Richards et al. ” A phase 2 adjuvant trial of GI-4000 plus Gem vs. Gem alone in Ras mutation+ resected pancreas cancer:  R1 subgroup and proteomic analysis .” Companion poster to ESMO-GI oral presentation.  2012 ESMO-GI, Barcelona Spain, 27 June 2012.
• Muscarella et al.  ” A randomized, placebo-controlled, double blind, multicenter   phase II adjuvant trial of the efficacy, immunogenicity, and safety of GI-4000 plus gem versus gem alone in patients with resected pancreas cancer with activating RAS mutations/survival and immunology analysis of the R1 subgroup. ” ASCO ePublication of Abstract; J Clin Oncol 30, 2012 (suppl; abstr e14501).
• Tamburini et al. ” IL-6-inducing Whole Yeast-based Immunotherapy Directly Controls IL-12 dependent CD8 T-cell Responses ” J Immunother (2012) Vol. 35, Number 1, January 2012.

2011

• Gameiro et al. ” Exploitation of differential homeostatic proliferation of T-cell subsets following chemotherapy to enhance the efficacy of vaccine-mediated antitumor responses. ” Cancer Immunol Immunother (2011) 60:1227–1242.
• Cereda et al. ” Maturation of human dendritic cells with Saccharomyces cerevisiae (yeast) reduces the number and function of regulatory T cells and enhances the ratio of antigen-specific effectors to regulatory T cells. ” Vaccine (2011) Jul 12;29(31):4992-9. Epub May 11, 2011.
• Madan et al. ” A phase I trial of a yeast-based therapeutic cancer vaccine targeting CEA: preliminary evidence of safety and immunologic activity ” Poster Presentation; ASCO June 6, 2011.
• D’Angelo et al. ” GI-4000 vaccine as adjuvant consolidation therapy is immunogenic following definitive treatment in patients with stage I-III adenocarcinoma of the lung with KRAS mutations ” Poster presentation; ASCO June 4, 2011.
• Tanaka et al. ” Whole recombinant yeast vaccine induces antitumor immunity and improves survival in a genetically engineered mouse model of melanoma ” Gene Therapy (2011), 1–8; Online publication: March 10, 2011.

2010

• Vierling et al. ” GI-5005 Therapeutic Vaccine Improves Deficit in Cellular Immunity in IL28B Genotype T/T, Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 When Added to Standard of Care (SOC) Peg-IFN-Alfa2a/Ribavirin ” Poster presentation; AASLD November 2, 2010.
• Pockros et al. ” GI-5005 Therapeutic Vaccine Plus Peg-IFN/Riba Improves sustained Virologic Response Versus Peg-IFN/Riba in Prior Non-Responders with Genotype 1 Chronic HCV Infection ” ORAL presentation / poster handout; AASLD November 1, 2010.
• Bui et al. ” Mutation-specific control of BCR-ABL T315I positive leukemia with a recombinant yeast-based therapeutic vaccine in a murine model ” Vaccine 28 (2010) 6028-6035.
• 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. ” 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

• Habersetzer et al. ” GI-5005, a yeast vector vaccine expressing an NS3-core fusion protein for chronic HCV infection ” Current Opinion in Molecular Therapeutics (2009) 11(4), 456-462.
• 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.
• Remondo et al. ” Human dendritic cell maturation and activation by a heat-killed recombinant yeast (Saccharomyces cerevisiae) vector encoding carcinoembryonic antigen ” Vaccine (2009) 27(7):987-94.

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 ” Clin Cancer Res 2008;14(13).
• 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

• Frujita et al. ” Generation of a prophylactic melanoma vaccine using whole recombinant yeast expressing MART-1 ” Experimental Dermatology (2007) 16, 814-822.
• 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.
• Lu et al. ” Mutation-selective tumor remission with ras-targeted, whole yeast-based immunotherapy. ” Highlight Cover; Cancer Research 2004.

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