Approach to Targeting

Pharmacologic or biologic methods are usually employed in preclinical studies to establish the effect of altering the expression of the target gene or of interfering with the function of the target protein. Most approaches have utilized either small molecule inhibitors (often detected in screening assays) or monoclonal antibodies (MAbs) to interfere with the function of the target protein. In general, small molecule inhibitors have a short half-life and are orally delivered on a continuous long-term basis. However, side effects can be common and potentially troublesome, especially if there is a broader substrate for related cellular proteins/kinases. By contrast, MAbs have a longer half-life with a more acceptable toxicity profile, although they require regular intravenous administration. Monoclonal antibodies usually target surface receptors and may also lead to receptor downregulation, although there is the additional theoretical potential for direct tumor cell cytotoxicity via complement and antibody (antibody-mediated cellular cytotoxicity, ADCC). Side effects may relate to hypersensitivity reactions, with the potential also to develop human antimonoclonal antibodies (HAMAs) that may limit effectiveness. Other approaches to targeting include the use of antisense technology to inhibit target messenger RNA that is transcribed from a given gene, although a key limiting factor is appropriate delivery of nucleic acids to the tumor cell. The use of viral vectors in targeted therapy approaches to modify/replace or inhibit target genes has therefore attracted much attention, and this method has been used to replace or stabilize key tumor suppressor proteins that may regulate cell survival and apoptosis.

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