New Fusion Tag for Site-specific Conjugation of Payloads to Targeting Proteins

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New Fusion Tag for Site-specific Conjugation of Payloads to Targeting Proteins

Description

Targeted delivery of therapeutic and diagnostic agents might significantly decrease systemic toxicity, increase efficacy of new and old drugs, support development of personalized medicine, and provide new uses for existing therapeutic proteins. Although many proteins can be used for targeted delivery, random conjugation of a "payload" to a protein creates heterogeneous products that are not well-suited for development and for regulatory approval. This invention eliminates random conjugation and provides a strategy for development of functionally active, homogeneous protein-based products. In this strategy, a protein is expressed with a humanized 15-aa cysteine-containing tag (Cys-tag), and a payload is site-specifically conjugated to a cysteine residue in Cys-tag via thiol-directed chemistries. Cys-tag is compatible with every protein tested so far, and accommodates payloads as different as drugs, contrast agents, dendrimers, liposomes, and functional proteins.

Benefits and Applications

Cys-tagged protein can be used for targeted delivery of therapeutic and diagnostic agents, dramatically expanding the field of use for a given protein therapeutic
Cys-tagged protein can be used in development of protein therapeutics to establish biodistribution and internalization
Cys-tagged protein can be modified to alter pharmacokinetic via site-specific pegylation
Cys-tagged protein can be modified to suit specific formulation, for example, slow-release formulations
Cys-tagged protein can be conjugated to tissue engineering scaffolds, biomedical surfaces, or nanoparticles, providing uniform protein-derivatized constructs

Intellectual Property Status

Patent Pending (US PTO #20050221431)

Related Publication

Mol. Cancer. Ther. 4, 1423-1429, 2005
Europ. J. Nucl. Med. Mol. Imag. 33, 841-848, 2006
Anti-Cancer Agents Med. Chem. 6, 167-184, 2006
Bioconjugate Chem., 17, 912-919, 2006
Biomaterials 27, 5452-5458, 2006

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