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Experimental antibody shows early promise for treatment of childhood tumor
Date:5/8/2014

doses of hu14.18K322A. The immunotherapy is designed to activate the disease-fighting immune system to attack and kill tumor cells. Every 28 days, patients received an infusion of hu14.18K322A once daily for four days.

Of the 31 patients evaluated after two or more rounds of treatment, the disease stabilized in nine patients, tumors shrank in two patients and were undetectable in four more, researchers reported. "Four patients are alive after more than two-and-a-half years without additional therapy," Navid said.

Hu14.18K322A is an antibody engineered to recognize and attach to a molecule called the GD2 antigen. GD2 is found on the surface of almost all neuroblastoma cells as well as other tumors, including the skin cancer melanoma, the bone cancer osteosarcoma and soft-tissue sarcomas. The antigen is found on the normal cells of just a few tissues.

The antibody is produced in the Children's GMP, LLC. Navid said the study would not have been possible without the GMP, an on-site facility that makes highly specialized medicines and other biologics under government-approved Good Manufacturing Practices regulations.

The monoclonal antibody in this study is one of several antibodies targeting GD2 that are in clinical development for treatment of neuroblastoma. Hu14.18K322A is a modified version of another antibody. The main change, a point mutation in the human gene for hu14.18, was designed to address treatment-limiting pain by generating a more tailored response that avoided triggering part of the immune response called the complement cascade. In addition, the hu14.18K322A has fewer mouse components, making it less likely the body will reject the antibody. It is also made in a cell line that may improve its ability to kill tumor cells.

In this study, pain remained the most common side effect associated with hu14.18K322A treatment. While 68 percent of patients reported severe pain during the first round of treatment, Navid
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Contact: Summer Freeman
summer.freeman@stjude.org
901-595-3061
St. Jude Children's Research Hospital
Source:Eurekalert

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