GlobeImmune Announces First Quarter 2015 Results and Corporate Highlights - Seite 2

The GI-6301 Tarmogen, exclusively licensed to Celgene Corporation, is designed to target cancers expressing the brachyury protein, which plays a role in metastatic progression of certain cancers and the initiation of chordoma. Based on previously reported data from the Phase 1 study, a Phase 2 trial was initiated in April at the National Cancer Institute (NCI) that was designed together with the GlobeImmune's collaborators at the NCI, the Chordoma Foundation and Celgene.

• 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. [www.clinicaltrials.gov; NCT02383498]

GI-6207
The GI-6207 Tarmogen targets carcinoembryonic antigen (CEA), a protein that is over-expressed in a large number of epithelial cancers. GI-6207 is being evaluated in a Phase 2 clinical trial at the NCI in subjects with medullary thyroid cancer (MTC). Development and commercialization rights to the GI-6200 program, including GI-6207, remain subject to option by Celgene. Celgene has the option to exclusively license GI-6207 after the data from the Phase 2 trial in MTC are available.

• The GI-6207-02 Phase 2 study is designed to enroll a total of 34 subjects in a cross-over trial design. Subjects 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 blood that correlates with tumor burden in MTC. Elevated calcitonin values after surgery indicate persistent or recurrent disease. Based on current enrollment rates, we believe that this trial could be fully enrolled in the fourth quarter 2015 or the first quarter 2016 with results available in the second half of 2016. [www.clinicaltrials.gov; NCT01856920]

Financial Results - First Quarter Ended March 31, 2015