ETBX-011 is an investigational cancer vaccine being developed by Etubics to treat patients with cancers that express carcinoembryonic antigen (CEA), a protein produced by many different types of cancer cells. It has been tested so far in colon cancer patients.
How ETBX-011 works
ETBX-011 is made by manipulating the genes inside a virus to express CEA. The virus, called the vector, carries CEA inside the body to be recognized by immune cells, which prime the immune system to mount a response against CEA-positive cancer cells.
ETBX-011 fights cancer by stimulating both the production of antibodies directed against CEA, and the production of T-cells that attack CEA-positive cells. This process is called cell-mediated immunity, or CMI.
ETBX-011 in clinical trials
A Phase 1/2 clinical trial (NCT01147965) tested the safety and effectiveness of ETBX-011 in adults with CEA-expressing advanced or metastatic colon cancer, whose cancer had returned after standard-of-care treatment. Patients received under-the-skin injections of the drug every three weeks, for a total of three immunizations.
Results, published in a 2013 issue of the scientific journal Cancer Immunology and Immunotherapy, showed that ETBX-011 stimulated significant CMI responses to CEA, even in patients who already had antibodies against adenovirus, and was safe and well-tolerated. According to its authors, these results support ETBX-011 advancing to a larger and randomized trial.
A Phase 1/2 trial (NCT03127098), being run by NantCell, a division of Nant that is an investment partner of Etubics, is testing the safety and effectiveness of ETBX-011 when combined with ALT-803, an immunotherapy drug that strengthens the immune response. This small, single-site trial also involves adults with locally advanced or metastatic CEA-expressing colon cancer that has returned after standard of care treatment. ETBX-011 will be administered as a fixed dose, with ALT-803 given in increasing doses. The study began in April 2017 and is expected to finish collecting data in early 2020.
Many other trials plan to test ETBX-011 in combination with different immunotherapy and chemotherapy drugs for several different types of cancer, but most are not yet open for recruitment. One that is, a Phase 1/2 trial (NCT03136406) taking place at a single site in California, is currently enrolling people with pancreatic cancer that has progressed on or after standard treatment.
The viral vector in ETBX-011 is a type of adenovirus, a virus that some people may already be immune to. With some vaccines that use a viral vector, the immune system attacks the virus itself and eliminates it, along with the cancer protein it carries, before it is able to do its job. ETBX-011 uses a viral vector technology that changes the virus to avoid such immune system attacks.
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