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MEDI5395 is a recombinant, attenuated oncolytic virus based on the Newcastle disease virus (NDV), genetically engineered to express a human granulocyte-macrophage colony-stimulating factor (GM-CSF) transgene. It is designed for systemic administration and functions as an immunotherapy for cancer. The drug selectively infects and lyses tumor cells while sparing normal cells. In addition to direct oncolysis, the expression of GM-CSF enhances antitumor immune responses by stimulating immune cell recruitment and activation within the tumor microenvironment. Preclinical studies have shown that its antitumor effects are further augmented when combined with PD-1/PD-L1 axis blockade therapies such as durvalumab. MEDI5395 is being developed primarily for advanced solid tumors[1][3][4][6].
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