Celgene Corporation will license GI-6207

[Longmont Times-Call]

Courtesy of GlobeImmune, Inc

GlobeImmune, Inc. (NASDAQ: GBIM) of Louisville announced on Aug. 12, 2015, that Celgene Corporation exercised its option under the 2009 Collaboration and Option Agreement to exclusively license GI-6207, a Tarmogen® product candidate targeting cancers that express carcinoembryonic antigen (CEA). GI-6207 is the second Tarmogen product candidate licensed by Celgene Corporation (NASDAQ: CELG) under the collaboration. Under the terms of the agreement, GlobeImmune will receive an option exercise payment of $1.9 million, and is eligible for regulatory and sales milestones, as well as royalties on product sales in exchange for a worldwide license. GI-6207 is currently being evaluated in a Phase 2 clinical trial at the National Cancer Institute (NCI) to evaluate GI-6207 in subjects with medullary thyroid cancer (MTC).

"We are very pleased that Celgene has exercised their option to license this program," said Timothy C. Rodell, M.D., FCCP, President and CEO of GlobeImmune, Inc. "We look forward to results from the MTC phase 2 trial in the second half of 2016."

Phase 2 MTC Trial GI-6207-02 is a 34 patient, randomized Phase 2 study being conducted at the NCI, which is approximately 80 percent enrolled. Under the protocol, patients are administered either GI-6207 for one year or 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 correlates with tumor size in MTC. Elevated calcitonin values after surgery indicate persistent or recurrent disease. [www.clinicaltrials.gov; NCT01856920]

Thyroid cancer is the most common type of endocrine malignancy in the U.S. with approximately 62,450 new cases estimated in 2015. Medullary thyroid cancer, a subtype of thyroid cancer has a poor prognosis with approximately 25 percent and 10 percent of patients alive at five and ten years, respectively. Furthermore, metastatic MTC is largely unresponsive to conventional chemotherapy and radiotherapy. Two drugs have been approved for the treatment of metastatic MTC. Both of these products were approved on the basis of improved progression free survival; neither has yet shown improved overall survival, and both of them have substantial side effects that limit their use.

The GI-6207 is a Tarmogen that expresses a modified version of CEA protein as the target cancer antigen. CEA is over-expressed in multiple human epithelial cancers, including MTC, where studies have indicated CEA is almost universally expressed and is a diagnostic marker of the disease. Preclinical studies have shown that GI-6207 can induce an immune response to CEA as well as therapeutic anti-tumor responses. In a previous Phase 1 study of monotherapy GI-6207, 20 percent of subjects (5/25) had stable or decreased CEA levels and stable disease after receiving GI-6207.

For more information on GlobeImmune, a biopharmaceutical company focused on developing products for the treatment of cancer and infectious diseases based on its proprietary Tarmogen® platform, go to www.globeimmune.com.