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EDP1503 is an orally delivered, non-live, monoclonal microbial candidate developed by Evelo Biosciences for the treatment of various advanced cancers. Originally licensed from the University of Chicago, the drug consists of a single strain of *Bifidobacterium animalis* subsp. *lactis*. It is designed to act on the small intestinal axis (SINTAX) to modulate the systemic immune system without being absorbed into the bloodstream. By interacting with immune cells in the small intestine, EDP1503 aims to induce a systemic pro-inflammatory response that enhances anti-tumor T-cell activity. It has been primarily investigated in Phase 1/2 clinical trials in combination with the PD-1 inhibitor pembrolizumab (Keytruda) to treat patients with microsatellite stable colorectal cancer (MSS CRC), triple-negative breast cancer (TNBC), and tumors that have relapsed following checkpoint inhibitor therapy.
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