GlobeImmune, Inc., a biopharmaceutical company, focuses on developing therapeutic products for cancer and infectious diseases based on proprietary Tarmogen platform. Its product candidate includes GI-4000, which is in Phase 2b clinical trials for the treatment of resected pancreas cancer; and has completed Phase 2a clinical trial to treat non-small cell lung cancer, as well as in Phase 2a clinical study for the treatment of colorectal cancer. The company’s product candidates also comprise GI-6207 that is in Phase 2 clinical trials to treat medullary thyroid cancer; GI-6301, which is in Phase 1 clinical trial for the treatment of chordoma and breast cancer; and GS-4774 that is in Phase 2 clin...
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GlobeImmune Inc. Announces Opening of Randomized Phase 2 Chordoma Trial at National Cancer Institute
Apr 22 15
GlobeImmune Inc. announced that a randomized Phase 2 clinical trial designed to investigate the safety and efficacy of GI-6301 in combination with radiation therapy in patients with chordoma is open for enrollment at the National Cancer Institute. The Company believes that the GI-6301 Tarmogen(R), exclusively licensed to Celgen Corporation, has demonstrated promising initial results in chordoma patients evaluated in a recent Phase 1 study. The literature suggests that, while radiation can often achieve temporary local control, it rarely results in tumor shrinkage. The GI-6301-02 Phase 2 clinical trial is a randomized, double-blind, placebo controlled trial of GI-6301, in combination with standard of care radiation for patients with locally advanced, unresectable chordoma. The primary endpoint for the trial will be overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST, a scoring system used to evaluate tumor response, after up to 24 months of treatment. Participants randomized to the placebo arm will be allowed to cross-over to receive GI-6301 at time of confirmed disease progression. This Phase 2 trial was designed together with the Company's collaborators at the NCI.
GlobeImmune Inc. Replaces KPMG LLP with EKS&H LLLP as New Independent Registered Public Accounting Firm
Apr 2 15
GlobeImmune Inc. announced that on April 1, 2015, KPMG LLP was dismissed as the independent registered public accounting firm of the company. The company's audit committee of the board of directors approved the dismissal of KPMG. On April 1, 2015, the company engaged EKS&H LLLP (EKS&H) as its new independent registered public accounting firm to act as the principal accountant to audit company's financial statements.
Globeimmune, Inc. Provides Update on Business and Clinical Programs; Reports Earnings Results for the Year Ended December 31, 2014
Mar 17 15
GlobeImmune Inc. provided an update on the company's business and clinical programs. Program Updates: GS-4774 for Chronic Hepatitis B Infectio: -4774 is a Tarmogen designed to treat patients chronically infected with HBV who are also on, or are candidates for, oral antiviral suppressive therapy. GS-4774 is being developed pursuant to a worldwide collaboration agreement with Gilead Sciences Inc., and is currently being evaluated in two randomized Phase 2 trials: GS-US-330-0101, or the 0101 trial, is a randomized Phase 2 clinical trial, initiated in 2013, investigating GS-4774 in combination with ongoing oral antiviral treatment in patients with chronic HBV infection. The 0101 trial is a multicenter, multinational trial that enrolled 175 patients in a randomized, open-label design comparing three different doses of GS-4774, administered in combination with oral antiviral therapy versus antiviral treatment alone. The primary endpoint for this trial is decline in serum HBV surface antigen, or HBsAg. The 0101 trial is fully-enrolled, and 48-week results are expected to be available in the first half of 2015. These results may be submitted to an upcoming scientific conference. GS-US-330-1401, or the 1401 trial, is a randomized Phase 2 clinical trial, initiated in 2014, investigating GS-4774 in patients with chronic HBV infection who are currently not receiving treatment. The 1401 trial is a multicenter, multinational trial designed to enroll 175 patients in a randomized, open-label design comparing three different doses of GS-4774, administered in combination with tenofovir disoproxil fumarate, or TDF, versus TDF alone. The 1401 trial is actively enrolling patients. The 48-week results are projected to be available in the middle of 2016. GI-6301 for Cancers Expressing Brachyury Protein: GI-6301 is a Tarmogen designed to target cancers expressing the brachyury protein, which plays a role in metastatic progression of certain cancers and the initiation of chordoma. The GI-6300 program, including GI-6301, is exclusively licensed to Celgene Corporation. The GI-6301-01 trial, a Phase 1 dose-escalation clinical trial in patients with metastatic cancers or chordoma who have failed previous therapy or have no further therapeutic options, is completely enrolled. Of the 34 patients enrolled in this Phase 1 trial, 11 had chordoma. Data for the 11 chordoma patients in the Phase 1 trial were presented in October at the 2014 Connective Tissue Oncology Society (CTOS) Annual Meeting in Berlin, Germany. Highlights included: An 82% Overall Response Rate (ORR), with nine of 11 chordoma patients showing Partial Response (PR) or Stable Disease (SD); One patient with a partial response (9%) by RECIST that has continued past one year; Eight patients (73%) had stable disease by RECIST, with 75% of these (6/8) having progressive disease at study entry which stabilized during administration of GI-6301. The Company believes that the summary results from the 11 chordoma patients enrolled in this trial compare favorably with historically published data. A Phase 2 study in chordoma is being prepared for initiation at the NCI. This trial will be a randomized Phase 2 design, evaluating GI-6301 in combination with radiation therapy. The company anticipates the NCI will open the trial for enrollment in the first half of 2015. GI-6207 for Cancers Expressing Carcinoembryonic Antigen: GI-6207 is a Tarmogen that expresses a modified version of the human CEA protein as the target cancer antigen. CEA is over-expressed in a number of human epithelial cancers, including NSCLC, colorectal, pancreas, breast, gastric and medullary thyroid cancer (MTC). Development and commercialization rights to the GI-6200 program, including GI-6207, remain subject to option by Celgene Corporation. GI-6207 is being evaluated in a Phase 2 clinical trial at the NCI in patients with medullary thyroid cancer. GI-6207-02 is a randomized Phase 2 study, being performed at the NCI that is planned to enroll a total of 34 patients in a cross-over trial design. Patients will be administered either GI- 6207 for one year or be observed for six months and then administered GI-6207 for one year. The primary endpoint for the trial will be the effect of GI-6207 on changes in calcitonin levels. Calcitonin is a tumor marker that can be measured in a patient's circulating blood that correlates with tumor burden in MTC. GI-19000 Tarmogens for Tuberculosis: Tuberculosis (TB) once considered mostly eliminated, now is a common, and in many cases lethal infectious disease. In 2013, the company was awarded a $4 million Research Project Grant by the NIAID of the NIH to support the development of Tarmogen immunotherapy product candidates intended to treat or prevent tuberculosis infection. The work done under this grant is being performed and reimbursed over four years. Initial Tarmogen product candidates have been constructed utilizing a combination of novel tuberculosis protein targets. Early non-clinical experiments show these constructs generate antigen-specific T cell immune responses. These constructs are being evaluated with the Company's collaborators at Colorado State University in various mouse and guinea pig models of TB infection.
The company reported earnings results for the year ended December 31, 2014. For the year, the company reported a net loss of $16.3 million compared to a net income of $9.5 million in 2013. The net loss for 2014 was due primarily to a decrease in collaboration payments and milestone revenue, as well as non-cash interest expense, the early retirement expense associated with convertible notes and fair-value adjustments of warrants upon the closing of the company's initial public offering. Loss applicable to common stockholders was $23.4 million, or $8.04 per share compared to loss applicable to common stockholders of $3.4 million, or $36.84 per share, in 2013.