BruCells SA/NV, the Belgium based therapeutic vaccine cancer company, announces that it has received from the US Food and Drug Agency (FDA) an Orphan Drug Designation (ODD) for its drug development product BCL005 for the treatment of grades IIb to IV in HLA-A2 positive Melanoma patients.
The principle of therapeutic vaccines is to trigger the immune system of cancer patients to recognize and destroy cancer cells by presenting tumour specific antigens. The products developed by BruCells combine the ability of dendritic cells to present antigens, with tumour cells as the sources of multiple tumour antigens. This is achieved by cellular fusion between dendritic and cancer cells, resulting in hybrids cells that are particularly potent in causing anti-cancer responses.
The dendritic cells and the cancer cells used in the production of BruCells therapeutic fusion vaccines are both obtained from sustainable cell lines and do not require the collection of biological material from the patients. This unique feature allows the production of vaccine dosage forms in advance and under reproducible pharmaceutical conditions.
The pre-clinical tests of BCL005 suggest that the vaccine is capable of triggering a specific immune response against several antigens present in most melanoma cancers. There is a possibility that the use of plasmacytoid DCs instead of the more common myeloid DCs reduces the regulatory response to the vaccine, which is one of the main reasons for the limited efficacy of therapeutic vaccines.
About BruCells: BruCells SA is a Belgian company specializing in the development of therapeutic cancer vaccines using dendritic cells from cell lines. The company has numerous collaborations with academic hospitals and research centers. http://www.brucells.com
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