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ActoBio Therapeutics(TM) Receives IND Green Light for New Antigen-Specific Immunotherapy Study Aimed at Improving Celiac Patients' Tolerance of Gluten
GHENT, Belgium, Aug. 19, 2019 /PRNewswire/ -- ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation (NASDAQ: XON) and innovative
About this update from Precigen, Inc.
[{"type":"text","content":"GHENT, Belgium, Aug. 19, 2019 /PRNewswire/ -- ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation (NASDAQ: XON) and innovative clinical-stage biotechnology company focused on a new class of microbe-based therapeutic agents, announced that the U.S. Food and Drug Administration (FDA) has given its permission to an Investigational New Drug (IND) application for AG017, an innovative orally-delivered therapeutic candidate for the treatment of celiac disease. ActoBio Therapeutics™ plans to enroll celiac disease patients in the Phase Ib/IIa study in the U.S. and Europe later this year. \n\n \nActoBio Therapeutics™ is dedicated to developing and commercializing the next generation of oral antigen-specific immunotherapy utilizing its proprietary delivery vehicle. ActoBiotics® programs are very well suited to address unmet needs in a wide range of autoimmune and allergic diseases through induction of antigen-specific immune tolerance that can prevent, retard or reverse the disease. ActoBiotics® AG017 for the treatment of celiac disease will be the second antigen-specific investigational immunotherapy candidate in clinical development following ActoBiotics® AG019, which is currently in a Phase Ib/IIa clinical study for the treatment of type 1 diabetes. Both programs will help further advance the Company's strategy to develop antigen-specific immunotherapies toward other autoimmune indications. \nActoBio Therapeutics™ is developing oral ActoBiotics® AG017 capsules based on the safe food-grade bacterium Lactococcus lactis which is specifically engineered to express a gliadin peptide in combination with an immunomodulating cytokine. ActoBiotics® AG017 is an antigen-specific investigational immunotherapy candidate with the potential to reverse gluten sensitivity. Over 90% of patients with celiac disease have an HLA-DQ2.5 genotype, and the target population for the clinical trial is patients within this group whose celiac disease is well controlled on a gluten‑free diet.\nCeliac disease is a chronic intestinal inflammatory disorder estimated to affect 1 in 100 people worldwide and is caused by an autoimmune reaction triggered by ingestion of dietary gluten proteins. The subsequent intestinal damage leads to malabsorption of some nutrients, along with diarrhea, bloating, weight loss, fatigue and anemia, as well as serio...