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UPEC-FimON (also known as DOR-100 or HOPEC) is a first-in-class, whole-cell, inactivated, genetically modified bacterial immunotherapy developed by Hopec Pharma for the treatment of non-muscle invasive bladder cancer (NMIBC). It consists of a genetically engineered strain of uropathogenic Escherichia coli (UPEC) that lacks hemolysin A and is modified to constantly express type 1 fimbriae. The fimbriae allow the bacteria to selectively bind to mannosylated (mannose-rich) receptors, which are overexpressed on bladder cancer cells. Following attachment, the bacteria trigger a localized immune response mediated by T cells and natural killer (NK) cells against the tumor. The bacteria are inactivated with formaldehyde to preserve their binding capability while eliminating the risk of infection. UPEC-FimON is administered intravesically and is being evaluated in Phase Ia/Ib clinical trials as an alternative to Bacillus Calmette-Guérin (BCG) and standard intravesical chemotherapies.
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