On August 4, 2015 GlobeImmune, Inc. announced today 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) (Filing, 8-K, GlobeImmune, AUG 4, 2015, View Source [SID:1234507002]).

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GI-6207 is the second Tarmogen product candidate licensed by Celgene 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."

GI-6207-02 – Phase 2 MTC Trial
GI-6207-02 is a 34 patient, randomized Phase 2 study being conducted at the NCI, which is approximately 80% 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]

Medullary Thyroid Cancer
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.
GI-6207

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% of subjects (5/25) had stable or decreased CEA levels and stable disease after receiving GI-6207.

On August 4, 2015, Janssen Diagnostics reported that a clinical trial involving the company’s CELLSEARCH System has been recognized by the editors of Clinical Cancer Research as being among the most significant studies to appear in the journal in its 20 year history (Press release, Johnson & Johnson, AUG 4, 2015, View Source [SID:1234506996]).

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The study revealed the prevalence of circulating tumor cells (CTCs) in most major cancers2, and established the analytical accuracy, reproducibility, and linearity of the CELLSEARCH System in capturing CTCs. This research demonstrated that the CELLSEARCH System could be used as a reliable tool to investigate CTCs and their clinical utility. The trial, "Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases," was published in 20043 and ignited interest in the clinical use of CTC testing.

The FDA cleared the CELLSEARCH System for use in the management of individuals with metastatic breast cancer, and subsequently expanded this clearance for use in the management of individuals with metastatic prostate* and colorectal cancers. To date, the CELLSEARCH System remains as the only CTC test to earn FDA clearance for use in patient management, and has also earned approval by the China FDA for the management of individuals with metastatic breast cancer.

CTCs are cancer cells that have detached from the tumor and entered the bloodstream. The highly sensitive and selective CELLSEARCH System can detect CTCs via a routine blood test. The trial referenced in Clinical Cancer Research demonstrated that these rare cells are not present in individuals without cancer. The value of capturing and counting CTCs continues to evolve as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding more precise and personalized cancer therapy.

"Studies have repeatedly demonstrated the accuracy of CTC enumeration to predict survival in patients with metastatic breast, prostate and colorectal cancers," notes Mark C. Connelly, Ph.D., Scientific Director, Janssen Diagnostics and one of the investigators involved in the trial published in Clinical Cancer Research. "The CELLSEARCH System can help detect changes in disease progression at any time which can help oncologists and their patients make more informed clinical decisions."

Clinical data from 28 independent prospective studies involving more than 4,700 patients have validated the clinical performance and value of CELLSEARCH System CTC testing as a reliable prognostic factor for progression-free survival and overall survival both before and after therapy initiation. Data obtained with the CELLSEARCH System have been published in more than 100 peer-reviewed publications.

Intended Use: The CELLSEARCH Circulating Tumor Cell Kit is intended for the enumeration of CTC of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast, colorectal or prostate* cancer. The test is intended to be used as an aid in the monitoring of patients with metastatic breast, colorectal or prostate cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast, colorectal and prostate cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.

*Metastatic prostate cancer patients in this study were defined as having two consecutive increases in the serum marker PSA above a reference level, despite standard hormonal management. These patients are commonly described as having androgen-independent, hormone-resistant, or castration-resistant prostate cancer.