SOURCE: GlobeImmune, Inc.

October 25, 2007 06:00 ET

GlobeImmune, Inc. Announces Presentation of Pre-Clinical Data on GI-10001 for Chronic Myelogenous Leukemia (CML) at International Conference on Molecular Targets and Cancer Therapeutics

LOUISVILLE, CO--(Marketwire - October 25, 2007) - GlobeImmune, Inc. announced today results from research on its GI-10001 Tarmogen® which is being investigated for the treatment of drug resistant chronic myelogenous leukemia (CML). Leukemia driven by the Bcr-Abl T315I mutation, known as the "gate-keeper" mutation, is resistant to treatment with imatinib mesylate or newer tyrosine kinase inhibitors including dasatinib or nilotinib. New data in mice show that treatment with GI-10001, which expresses T315I-mutated Bcr-Abl protein, triggered the immune system to selectively eliminate leukemic cells with this mutation. In addition, the Tarmogen significantly extended survival in mice after lethal challenge with cells driven by the T315I mutated Bcr-Abl.

These data will be presented in a poster entitled, "Control of Leukemia Driven by the T315I Escape Mutation in Bcr-Abl with Yeast-Based Tarmogen Immunotherapy," at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco. The poster will be available for download from the Company's website on Friday, October 26.

Presentation details:
Thursday, October 25, 2007
12:30-2:30pm -and- 5:30-7:30pm
Abstract # C251
Poster Session C

"These early data, which are part of our Target Ablation of Mutational Escape (TAME) research program, are very exciting because they demonstrate potential protection against the most common CML therapy-resistant mutation," said Timothy C. Rodell, M.D., GlobeImmune's President and CEO. "This Tarmogen, in combination with targeted cancer therapies such as imatinib, may make these small molecule drugs more effective by preventing or treating resistance."

In this study, leukemic cells with and without the T315I mutation were transferred into recipient mice, half of which had received the T315I Tarmogen and half of which were left untreated. Animals receiving the T315I-specific Tarmogen were protected from challenge as measured both by the percentage of circulating leukemic cells as well as survival compared to untreated mice.

About GI-10001

Tarmogens (Targeted Molecular Immunogens) are a proprietary, immunotherapeutic platform utilizing whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express disease-specific protein targets. The GI-10001 Tarmogen expresses the threonine-to-isoleucine mutation at codon 315 of Bcr-Abl (T315I mutation). This is the most prevalent escape mutation to imatinib, dasatinib, and nilotinib which are common treatments for CML. Additionally, GlobeImmune is investigating a version of GI-10001 that directly targets the causative Bcr-Abl junctional mutation in an analogous model.

About Chronic Myelogenous Leukemia (CML)

CML is cancer of the blood system in which too many white blood cells belonging to the myeloid line of cells are produced in bone marrow. CML is the result of growth and evolution of an abnormal chromosome rearrangement known as the Philadelphia chromosome which contains a fused Bcr-Abl gene. The goal of treatment is to stabilize the level of blood cells and eliminate all cells with the Bcr-Abl gene. Many CML patients are treated with a targeted cancer drug called imatinib mesylate or one of the several second generation inhibitors of Abl kinase for the treatment of CML.

The American Cancer Society estimates that in 2007 there will be about 4,570 new cases of CML in the United States and that about 490 will die of the disease. About 21,501 people in the United States are currently living with CML. The average age of people with CML is around 66 years.

About GlobeImmune, Inc.

GlobeImmune is a private Colorado-based company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection that has completed Phase 1b clinical trials. GI-5005 is designed to complement both the current and emerging standard of care for hepatitis C infection through the direct elimination of chronically infected cells. The Company plans to initiate a randomized, placebo-controlled Phase 2 study of GI-5005 in combination with standard of care for chronic hepatitis C infection before the end of 2007. The Company's lead oncology program, GI-4000, is designed to be a treatment for cancers of the lung and gastrointestinal tract. A randomized, placebo-controlled Phase 2 trial in patients with resectable pancreas cancer in combination with adjuvant gemcitabine is ongoing.

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

This press release contains forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and potential advantages of the Company's technology. Actual results could differ materially from those projected and the Company cautions investors not to place undue reliance on the forward-looking statements contained in this release.

Contact Information

  • GlobeImmune Contact:
    Timothy C. Rodell, M.D.
    President & Chief Executive Officer
    GlobeImmune, Inc.
    phone: (303) 625-2700
    Email Contact

    Media Contact:
    Brad Miles
    BMC Communications Group
    phone: (212) 477-9007 ext. 17