Nimotuzumab

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Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), a protein that helps control cell growth. By binding to the extracellular part of EGFR, nimotuzumab blocks the receptor from being activated and can slow the growth of cancer cells.

Developed in Havana, Cuba, nimotuzumab has been sold under various names and licensed around the world. CIMAB S.A. formed a joint venture with YM Biosciences (CIMYM BioSciences) in 1995. European rights were licensed to Oncoscience AG (2003), South Korea to Kuhnil Pharmaceutical (2005), and Japan to Daiichi Sankyo (2006). CIMYM BioSciences was dissolved in 2012 and nimotuzumab assets were sold to InnoKeys.

Clinically, nimotuzumab has orphan drug status for glioma in the US and EU (as of 2014) and has marketing approvals in India, China, and other countries for squamous cell carcinomas of the head and neck. It has been studied in glioma, nasopharyngeal cancer, and other cancers, with ongoing Phase I/II trials and at least one Phase III trial in lung cancer that was halted in 2014 due to safety concerns with a specific treatment combination.

Nimotuzumab is given by intravenous infusion. It is generally well tolerated, with fewer skin-related side effects than many other EGFR inhibitors. This better tolerability is thought to result from nimotuzumab’s selective binding to cells with moderate to high EGFR levels, sparing normal tissues. Common adverse effects vary by trial but are usually mild.