LOUISVILLE, CO--(Marketwired - August 04, 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). 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.
About GlobeImmune
GlobeImmune
is a biopharmaceutical company focused on developing products for the
treatment of cancer and infectious diseases based on its proprietary
Tarmogen® platform. Tarmogens activate the immune system by
stimulating cellular immunity, known as T cell immunity, in contrast to
traditional vaccines that predominately stimulate antibody production.
To date, Tarmogen product candidates have been generally well tolerated
in clinical trials for multiple disease indications and are efficient to
manufacture. In 2009, the Company entered into a worldwide strategic
collaboration and option agreement with Celgene Corporation focused on
the discovery, development and commercialization of product candidates
intended to treat cancer. Under this agreement, Celgene exercised their
option to take an exclusive worldwide license to the GI-6300 Tarmogen
product series, including GI-6301, targeting brachyury, as well as
taking a license to the GI-6200 product series, including GI-6207,
targeting carcinoembryonic antigen. In 2011, the Company entered into a
worldwide, strategic collaboration with Gilead Sciences, Inc., to
develop Tarmogens intended for the treatment of chronic hepatitis B
infection. For additional information, please visit the company's
website at www.globeimmune.com.