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EXL01 is a live biotherapeutic product containing a single, unmodified strain of the commensal bacterium Faecalibacterium prausnitzii. It is being developed as an oral therapy in gastro-resistant capsules to restore beneficial gut microbiota and modulate immune responses. The drug is designed to target NOD2 receptors in macrophages, acting as a proprietary NOD2 agonist with immunomodulatory properties. Its mechanisms include stimulating interleukin 10 secretion by regulatory T cells and inhibiting Th1 immunity, resulting in anti-inflammatory effects. EXL01 aims to address unmet needs across several indications including Crohn’s disease (to maintain remission), recurrent Clostridioides difficile infection (to prevent recurrence), and as an adjunct to immune checkpoint inhibitors for various cancers such as non-small cell lung cancer and hepatocellular carcinoma[1][2][3][4][5][6][7][8].
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