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IMM-101 + cyclophosphamide is a combination immunotherapy regimen investigated for its synergistic anti-tumor effects in advanced solid malignancies. IMM-101 is a systemic immune modulator consisting of a heat-killed preparation of the environmental bacterium *Mycobacterium obuense* (NCTC 13365). It acts primarily as a Toll-like receptor 2 (TLR2) agonist, stimulating the innate immune system by activating dendritic cells and natural killer cells, which in turn promotes a Th1-biased adaptive immune response. Cyclophosphamide is a nitrogen mustard alkylating agent that, when used in this combination at low metronomic doses, functions as an immunomodulator by selectively depleting regulatory T cells (Tregs). This depletion reduces immunosuppression within the tumor microenvironment, thereby enhancing the efficacy of the IMM-101-induced immune response. The combination has been explored in clinical trials for various cancers, including pancreatic cancer, melanoma, and colorectal cancer, aiming to improve overall survival and quality of life.
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