GlobeImmune, Inc announced the initiation of a phase-1 clinical trial to investigate the safety and tolerability of a new Tarmogen, GI-6207, in patients with metastatic cancers that over-express carcinoembryonic antigen (CEA). This is the third new Tarmogen product candidate to enter human clinical trials over the last four years.
James L Gulley, director of the Clinical Trials Group LTIB at the National Cancer Institute (NCI), will be the Principal Investigator for the study. This will be a single center phase-1 study funded by the NCI.
The GI-6207-01 study is an open-label, dose-escalation trial. The primary endpoint of the study is the safety and tolerability of escalating doses of GI-6207. Secondary endpoints include levels of CEA-specific T cells, reduction in CEA serum markers and circulating tumour cells and evidence of clinical benefit.
"Tarmogens are designed to activate the immune system to recognize and attack cells with disease-specific characteristics such as the over-expression of CEA," said Timothy Rodell, president and CEO of GlobeImmune. "This trial will build on our previous data with GI-4000 targeting mutated Ras in pancreas and colon cancers and, if successful, allows us to broaden the range of molecular targets for the Tarmogen platform. We are excited to be working with Dr Gulley and his colleagues at the NCI on this programme."
The GI-6207 Tarmogen consists of whole, heat-killed, recombinant S cerevisiae yeast, genetically modified to express CEA protein. CEA represents an important target for cancer therapies as it is over-expressed in more than 90 per cent of colorectal, gastric and pancreas cancers; 70 per cent of non-small cell lung cancers; and 50 per cent of breast cancers.
Last year, GlobeImmune signed a Cooperative Research and Development Agreement (CRADA) with NCI and the National Institutes of Health to jointly develop multiple product candidates intended to treat a variety of cancers. CEA is the first cancer antigen to be targeted in human trials through this collaboration.
GlobeImmune is a private company developing targeted molecular immunogens (Tarmogens) for the treatment of cancer and infectious diseases.