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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 ColitisBOCA RATON, Fla., Oct. 21, 2021 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today 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). “To have assembled such a prestigious group of medical experts from some of the nation’s most renowned cancer centers is an exciting development as we advance the exploration of FW-ICI-AC as a potential treatment for immune checkpoint inhibitor-associated colitis,” stated James Sapirstein, President and CEO of First Wave BioPharma. “Each committee member brings extensive expertise as researchers and clinicians in the treatment of the GI-related complications that often occur in cancer patients undergoing treatment with immunotherapies. We believe there is significant potential for FW-ICI-AC to be a difference maker that can help address the needs of millions of cancer patients who, due to GI-related complications, might otherwise be forced to cease immunotherapy treatment.” James Pennington, M.D., Chief Medical Officer for First Wave BioPharma, stated, “As many as 30 percent of cancer patients treated with checkpoint inhibitors develop diarrhea that can progress to colitis, a condition that can be debilitating and, at times, life-threatening due to the compromised heath of the patient. We believe niclosamide has the potential to be the first drug specifically for ICI-AC and, thus, could become a critical component to the treatment regimen for cancer patients receiving immune checkpoint inhibitors.” About the Steering Committee Dr. Michael Dougan is 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. He received an M.D. and a Ph.D. from Harvard Medical School, completing his dissertation work in Immunology with the renowned Glenn Dranoff, M.D., at the Dana-Farber Cancer Institute where he studied the interplay between chronic inflammation, tumor promotion, and antitumor immunity. In 2017, Dr. Dougan completed an Internal Medicine residency and Gastroenterology fellowship at Massachusetts General Hospital. Dr. David Faleck is 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. Faleck also leads research efforts focused on the prediction, evaluation, and management of immunotherapy-related colitis. He is the principal investigator at MSK on a NIH/NIDDK-funded collaborative U01 grant funding research to explore the pathways of inflammation in immunotherapy-related colitis and develop predictive biomarkers and novel management strategies and leads a grant-funded pilot clinical trial investigating the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of refractory immunotherapy-related colitis. Additionally, Dr. Faleck serves as co-principal investigator on a prospective Registry for Patients with Long-Standing Inflammatory Bowel Disease or Colitis-Associated Cancer that seeks to identify early biomarkers of IBD-associated dysplasia and cancer. Dr. Faleck is a graduate of the Albert Einstein College of Medicine at Yeshiva University where he was a recipient of the Golding Research Tuition Scholarship and was elected to the Alpha Omega Alpha medical honor society. He subsequently completed residency in internal medicine at Columbia University Medical Center and a fellowship in gastroenterology at the Mount Sinai Hospital. Dr. Aiwa Ruth He currently serves as an Associate Professor and Scientific Lead in Liver and Biliary Cancers at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital. As a physician scientist, she has more than 15 years of experience as an adult medical oncologist and a researcher investigating cancer biology and therapeutics. As a clinician, she has extensive experience treating patients with advanced hepatocellular cancer (HCC). As a researcher, she has served as primary or co-investigator on many peer-reviewed studies exploring novel therapeutics targeting STAT3 in IL6 signaling, poly (ADP-riose) polymerases in DNA repair, and kallistatin in Wnt signaling pathways. Her work as a clinical investigator has also included trials that supported FDA approval of new therapeutics for advanced HCC patients, including nivolumab, bevacizumab/atezolizumab combination, and nivolumab/ipilimumab combination. Dr. He graduated from the Hunan Medical University in 1991 and earned a Ph.D. in Biochemistry at East Carolina University School of Medicine. 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. In these roles, she leverages a deep academic background and clinical experience treating inflammatory bowel disease (IBD), fecal microbiota transplantation (FMT), and immunotherapy-induced colitis. A gastroenterologist by training, Dr. Wang arrived at MD Anderson in December 2016 from the Cleveland Clinic where she spent eight years in a tertiary IBD practice treating patients with Crohn’s disease and ulcerative colitis, and an additional two years focused on FMT patients with recurrent clostridioides difficile infection. At MD Anderson, Dr. Wang established institutional immunotherapy GI toxicity management guidelines and launched new services for IBD/cancer immunotherapy-induced GI toxicity and fecal transplantation. During the past five years, her clinical research has led to more than 60 published journal papers, four book chapters, and more than 70 conference presentations. Dr. Wang has assisted in writing guidelines regarding immunotherapy-induced GI toxicity for the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), Society for Immunotherapy of Cancer (SITC) and the American Gastroenterological Association (AGA). Dr. Wang holds a Ph.D. in Cellular and Molecular Physiology from Johns Hopkins University, an M.D. from China Medical University and an M.Sc. in Cardiovascular and Respiratory Sciences from the University of Calgary. About the PASSPORT Study About Immune Checkpoint Inhibitor-Associated Colitis About FW-ICI-AC About First Wave BioPharma, Inc. 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