Girentuximab
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Girentuximab (trade name Rencarex) is a chimeric IgG1
monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ca ...
to carbonic anhydrase IX (CAIX). CAIX is expressed on the surface of most renal cancer cells and is hypothesized to be on the surface of other tumor cells. It is investigational agent in clinical trials for
renal cell carcinoma Renal cell carcinoma (RCC) is a kidney cancer that originates in the lining of the proximal convoluted tubule, a part of the very small tubes in the kidney that transport primary urine. RCC is the most common type of kidney cancer in adults, resp ...
. Its development was suspended as a "naked" or unconjugated antibody during phase III trials due to efficacy. Girentuximab was originally developed by Wilex AG, Germany. It was granted
fast track The fast track is an informal English term meaning "the quickest and most direct route to achievement of a goal, as in competing for professional advancement". By definition, it implies that a less direct, slower route also exists. Fast track or F ...
status and
orphan drug designation An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...
by the
FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
for renal cancer. In January 2017, Telix Pharmaceuticals Limited, an Australian biotechnology company, announced that it had in-licensed Girentuximab for use as a radioimmunoconjugate. It triggers
antibody-dependent cell-mediated cytotoxicity Antibody-dependent cellular cytotoxicity (ADCC), also referred to as antibody-dependent cell-mediated cytotoxicity, is a mechanism of cell-mediated immune defense whereby an effector cell of the immune system actively lyses a target cell, whose ...
(ADCC). When it binds to its antigen ( carbonic anhydrase IX), it activates
natural killer cell Natural killer cells, also known as NK cells or large granular lymphocytes (LGL), are a type of cytotoxic lymphocyte critical to the innate immune system that belong to the rapidly expanding family of known innate lymphoid cells (ILC) and repres ...
s by binding to a receptor on the NK cells.


References

Monoclonal antibodies Abandoned drugs {{antineoplastic-drug-stub