Fusion Proteins

Several EPO fusion proteins have been reported, including EPO/IL-3 (140) and EPO/GM-CSF (141). The theory behind the creation of such molecules is that the single fusion protein can provide the biologic activity of both molecules and ensure that both entities are present simultaneously. For example, enhanced erythropoiesis might well result from the co-administration of rHuIL-3, which acts on the earliest erythroid precursor cells, with rHuEPO, which acts on the more mature precursors. The larger size of the fusion protein also may impart increased activity for both partners because of reduced clearance. EPO dimer is another fusion protein that has been generated as a potential therapeutic (142). Its increased size can reduce clearance, and the molecule may have increased activity owing to altered avidity to the receptor (143).

Simultaneous administration by fusing two drugs can simplify dosing, especially when the two proteins have different pharmacokinetic parameters; however, the ability to adjust dosing independently of the fusion partners is lost. Other challenges in creating therapeutic fusion proteins are their potential immunogenicity (141) and possible loss of efficacy (140), in that full activity of both proteins in fusion proteins may not occur.

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