GI-6207 is a cancer vaccine being developed by GlobeImmune to treat cancers that produce a protein called carcinoembryonic antigen (CEA). CEA is overproduced in certain cancers, including cancers of the lung, colon, pancreas, breast, and thyroid. Because normal cells have little to no CEA, the vaccine can target cancer cells without harming healthy tissue.
How GI-6207 works
GI-6207 is made by manipulating the genetic material inside sterilized baker’s yeast to make the CEA protein. The theory is that injecting GI-6207 into the body will prompt the immune system to mount an immune response against CEA by sending cytotoxic (cell-killing) T-cells to attack and destroy CEA-producing cancer cells.
GI-6207 in clinical trials
In an open-label Phase 1 safety study (NCT00924092), 25 adults with stage 4, CEA-producing cancers received under-the-skin GI-6207 vaccinations every two weeks and then every month, at different dose levels.
The results, published in a March 2014 issue of the scientific journal Cancer Immunology, Immunotherapy, showed that the vaccine was safe and was able to stimulate T-cell responses against CEA in some patients. The authors noted that a patient with medullary thyroid cancer (MTC) had a particularly strong T-cell response.
A Phase 2 trial (NCT01856920 ) in patients with metastatic MTC that returned after treatment is currently underway. In the study, which consists of two arms, patients are randomized to receive either six months’ surveillance followed by one year of GI-6207 treatment or one year of GI-6207 treatment from the start of the study.
The effectiveness of the GI-6207 vaccine will be judged by the change in blood levels of calcitonin, a hormone produced by the thyroid that serves as a marker for cancer in patients with MTC (a fall in calcitonin levels is indicative of the treatment working to kill cancer cells).
The trial began in 2013 and has an estimated primary completion date of September 2019. It is currently recruiting participants at the National Institutes of Health Clinical Center in Bethesda, Maryland.
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