First Wave BioPharma Forms Steering Committee for Phase 2a PASSPORT Clinical Trial to Evaluate FW-ICI-AC in Cancer Patients with Immune Checkpoint Inhibitor-Associated Colitis
October 21, 2021 at 12:30 pm
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First Wave BioPharma, Inc. announced the initial members of the steering committee for PASSPORT, the Company?s Phase 2a clinical trial investigating FW-ICI-AC as a treatment for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors (ICIs). FW-ICI-AC is a proprietary oral immediate-release tablet formulation of niclosamide, a prescription small molecule with anti-inflammatory and anti-viral properties. The four-member steering committee will provide management with strategic guidance and support during the initiation and execution of the PASSPORT trial. The committee members include Mike Dougan, Ph.D., M.D., Director of the Immunotherapy Mucosal Toxicities Program at Massachusetts General Hospital; Yinghong (?Mimi?) Wang, Ph.D., M.D., Director of Inflammatory Bowel Disorder and Director of Fecal Microbiota Transplantation, Department of Gastroenterology, Hepatology and Nutrition at University of Texas MD Anderson Cancer Center; Aiwa Ruth He, Ph.D., M.D., Assistant Professor, Division of Hematology and Oncology at Georgetown University Hospital; and David Faleck, M.D., Assistant Professor of Medicine at Weill Medical College and an attending physician in the Gastroenterology, Hepatology and Nutrition Service at Memorial Sloan Kettering Cancer Center (MSK). Dr. Michael Douganis currently an Assistant Professor of Medicine at Massachusetts General Hospital and Harvard Medical School and serves as Director of the Immunotherapy Mucosal Toxicities Program at Massachusetts General Hospital. Dr. David Faleckis an Assistant Professor of Medicine at Weill Medical College and an attending physician in the Gastroenterology, Hepatology and Nutrition Service at Memorial Sloan Kettering Cancer Center (MSK), where he directs the interdisciplinary management of patients with inflammatory bowel disease (IBD) and patients with gastrointestinal (GI) toxicities associated with cancer immunotherapies. Dr. Aiwa Ruth Hecurrently serves as an Associate Professor and Scientific Lead in Liver and Biliary Cancers at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital. Dr. Yinghong (?Mimi?) Wang serves as the Director of Inflammatory Bowel Disorder and Director of Fecal Microbiota Transplantation in the Department of Gastroenterology, Hepatology and Nutrition at the University of Texas MD Anderson Cancer Center, as well as chair of the facility?s immunotherapy toxicity working group.
Entero Therapeutics, Inc., formerly First Wave BioPharma, Inc., is a late clinical-stage biopharmaceutical company focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. Its programs address unmet needs in GI health and include latiglutenase, a Phase III-ready, oral biotherapeutic designed to aid gluten digestion and potentially reduce symptoms of celiac disease; capeserod, a selective 5-HT4 receptor partial agonist for multiple GI conditions, including gastroparesis, and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. The Company also intends to develop Niclosamide, an oral small molecule anti-inflammatory inhibitor therapy for the treatment of ulcerative proctitis and ulcerative proctosigmoiditis, and immune checkpoint inhibitor-associated colitis and diarrhea in metastatic cancer patients.
First Wave BioPharma Forms Steering Committee for Phase 2a PASSPORT Clinical Trial to Evaluate FW-ICI-AC in Cancer Patients with Immune Checkpoint Inhibitor-Associated Colitis