- Anti-CD3 oral immunotherapy: Oral anti-CD3 monoclonal antibody (aCD3 MAb) immunotherapy is directed toward the treatment of inflammatory and autoimmune diseases. Intravenous aCD3 MAb immunotherapy was approved for >20 years for the treatment of graft rejection after transplantation; however, its use for chronic inflammatory and autoimmune disease indications has been hampered due to its profile of significant AEs following injection. Preclinical studies have shown that oral aCD3 MAb does not induce side effects and confers efficacy in preventing induction or progression of disease in a range of animal models of inflammatory and autoimmune diseases. These studies also showed that oral aCD3 MAb induces regulatory T cells (Treg) and anti-inflammatory immune responses that convey efficacy. A Phase 2a clinical trial in 36 subjects with NASH (Nonalcoholic steatohepatitis) or “fatty liver” and the metabolic syndrome showed that oral aCD3 immunotherapy was safe and well-tolerated, and induced positive trends in clinical biomarkers and in immunological markers in groups receiving oral aCD3 MAb but not in the placebo group – some of these trends were statistically significant in spite of the very small group sizes. These favorable effects were reduced blood levels of two enzymes that are biomarkers for liver inflammation which is a favorable outcome for subjects with NASH, and reduced blood levels of glucose and triglycerides and improved performance in glucose tolerance testing which is a favorable outcome for subjects with type-2 diabetes or altered glucose metabolism. Another Phase 2a clinical trial in 36 subjects with chronic hepatitis C also showed that oral aCD3 immunotherapy was safe and well-tolerated, and induced favorable trends in clinical biomarkers and in immunological markers in groups receiving oral CD3 MAb but not in the placebo group – some of these trends also were statistically significant. These favorable effects were reduced blood levels of two enzymes that are biomarkers for liver inflammation and reduced blood levels of hepatitis C virus, both of which are favorable outcomes for subjects with chronic hepatitis C. The oral application for aCD3 MAb immunotherapy was discovered by Dr. Howard Weiner of Brigham & Women’s Hospital, Harvard Medical School in Boston, USA. A Phase 2a clinical trial as an Investigator IND study in the US is ongoing for subjects with ulcerative colitis.
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