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Combining cancer-selective viral replication and simultaneous production of a therapeutic cytokine, with potent "bystander" anti-tumor activity, are hallmarks of the cancer terminator virus ( CTV ). To expand on these attributes, we designed a next generation CTV that additionally enables simultaneous non-invasive imaging of tumors targeted for eradication. A unique tripartite CTV "theranostic" adenovirus ( TCTV ) has now been created that employs three distinct promoters to target virus replication, cytokine production and imaging capabilities uniquely in cancer cells. Conditional replication of the TCTV is regulated by a cancer-selective (truncated PEG-3 ) promoter, the therapeutic component, MDA-7/IL-24, is under a ubiquitous ( CMV ) promoter, and finally the imaging capabilities are synchronized through another cancer selective (truncated tCCN1 ) promoter. Using in vitro studies and clinically relevant in vivo models of breast and prostate cancer, we demonstrate that incorporating a reporter gene for imaging does not compromise the exceptional therapeutic efficacy of our previously reported bipartite CTV . This TCTV permits targeted treatment of tumors while monitoring tumor regression, with potential to simultaneously detect metastasis due to the cancer-selective activity of reporter gene expression. This "theranostic" virus provides a new genetic tool for distinguishing and treating localized and metastatic cancers.

Theranostic Tripartite Cancer Terminator Virus for Cancer Therapy and Imaging