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ORB-011 is a first-in-class, clinical-stage, engineered interferon designed to act with high precision on type 1 conventional dendritic cells (cDC1), which are potent activators of tumor cell-killing CD8+ T cells. It is an attenuated, cis-targeted interferon that specifically binds to and activates cDC1 dendritic immune cells. This targeted activation leads to the presentation of tumor antigens and activation of cytotoxic CD8+ T cells, resulting in potential immunostimulatory and antineoplastic effects. Preclinical studies have shown that selective activation of cDC1s by conditionally active interferon molecules can translate into effective antitumor activity while being well tolerated in non-human primates. ORB-011 is being developed by Orionis Biosciences and is currently undergoing Phase 1 clinical trials for the treatment of advanced solid tumors, including but not limited to colorectal cancer, HR+ or triple-negative breast cancer, non-small cell lung cancer, pancreatic cancer, head and neck squamous cell carcinoma, metastatic melanoma, bladder/urothelial cancers, gastric cancers, esophageal cancer, renal cell carcinoma, hepatic cancers and ovarian cancers[1][5][6].
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