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Activartis’ Cancer Immunotherapy Receives Orphan Drug Designation from FDA

Published: Monday, July 01, 2013
Last Updated: Monday, July 01, 2013
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The ODD applies specifically to the use of AV0113 for the treatment of malignant glioma, a very aggressive type of brain cancer.

The European drug agency EMA already granted ODD at the end of last year.

In principle, Activartis’ AV0113 Cancer Immunotherapy may be used to fight any type of cancer. The individualized therapeutic technology is based on a patented procedure in which a cancer patient’s immune system is primed to fight the tumor and eventually control its growth. This concept is based on the use of Dendritic Cells, the key regulatory elements of the immune system, that are the same as the tumor tissue derived from the patient.

Active cancer immunotherapy based on Dendritic Cells

AV0113 activates the patient’s immune system, with tumor cells being identified on the basis of their antigens and destroyed. The therapy makes use of elements and mechanisms of the immune system and gets to work where these fail. As tumor cells are the body’s own tissue, the immune system does not normally identify them as dangerous. Activartis’ AV0113 Cancer Immunotherapy “tricks” Dendritic Cells and, consequently, a cancer patient’s immune system, into doing the right thing, i.e. to perceive the tumor as a threat and to trigger adequate defense mechanisms.

The Dendritic Cells are charged with tumor-derived antigens, determinants that distinguish a tumor cell from a normal cell. These antigens are processed by the Dendritic Cell and shuttled to the cell surface in order to present them to T-cells. This, however, is not sufficient to prime an immune response against the tumor antigens. The “trick” referred to above is contacting Dendritic Cells with a microbial danger signal. Certain molecules that are present in microorganisms but not in higher organisms signal to the Dendritic Cell the presence of a microbial invasion in its surroundings and hence danger to the organism.

As tumor cells originate from a cancer patient’s normal cells, they do not provide danger molecules which are recognized by the Dendritic Cell. The critical and unique part of Activartis’ AV0113 technology is exposing tumor antigen-charged Dendritic Cells to one of these danger molecules: lipopolysaccharides, the bacterial endotoxins. This causes the Dendritic Cell to assume a potently immune stimulatory and pro-inflammatory mode of action. Upon returning these Dendritic Cells to the patient, they activate tumor-specific T-cells, most importantly the so-called cytotoxic T-cells, which become able to recognize and destroy tumor cells.

Early results of the Activartis AV0113 trial reveal a promising trend.

At the beginning of 2013, Activartis completed recruitment of 78 brain cancer patients to a multi-centre, randomized, phase II clinical trial. This randomized study aims to deliver safety and efficacy data for the first time. Preliminary results presented at the AACR Annual Meeting (April 6-10, 2013, Washington) revealed a very promising trend suggesting a survival benefit of patients in the AV0113 treatment group compared to the randomized control group.

Confirmation of that trend is expected by the end of 2013. If the trend currently observed is confirmed, AV0113 is bound to become part of the standard therapy for GBM.


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