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A combination therapy consisting of three agents: - **Ad-RTS-hIL-12**: an inducible adenoviral gene therapy vector engineered to express human interleukin-12 (IL-12) under control of an oral switch (RheoSwitch Therapeutic System) that is regulated by veledimex. This allows titratable and localized expression of IL-12, a cytokine that activates both innate and adaptive immunity and promotes anti-tumor activity[2][4][7]. - **Veledimex**: a small molecule oral activator of the RheoSwitch Therapeutic System, enabling controlled expression of IL-12 from the Ad-RTS-hIL-12 vector[1][2][6][7]. - **Palifosfamide**: a cytotoxic DNA crosslinker in the oxazaphosphorine class (active metabolite of ifosfamide), administered intravenously. It acts as an alkylator, damaging DNA and inducing cell death in rapidly dividing tumor cells[3][5][7]. This combination is developed for synergistic anti-tumor effects, particularly in cancers with accessible lesions, such as recurrent/metastatic breast cancer. Ad-RTS-hIL-12 delivers immune stimulation locally within the tumor, veledimex controls timing and dosing of IL-12 expression, and palifosfamide provides direct cytotoxicity[3][7].
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