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

Committee members include globally renowned experts in medical oncology, immune checkpoint inhibitor therapeutics, gastrointestinal (GI) diseases and cancer immunotherapy-related GI complications

BOCA 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-ribose) 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
The Phase 2a PASSPORT clinical trial is designed as a double-blind, placebo-controlled study to determine the safety, tolerability, and preliminary efficacy of FW-ICI-AC in the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and diarrhea in advanced cancer patients. 60 patients will be enrolled in the trial and divided into two arms (30 patients per arm). One arm will receive FW-ICI-AC three times daily for two weeks, while the other arm will receive placebo three times daily for two weeks. Following treatment, each patient will enter a four-week evaluation period. The primary endpoint of the trial is safety and tolerability of FW-ICI-AC. Additional endpoints will measure early signals of efficacy, including resolution of the patient’s diarrhea, sparing of steroids, and prevention of disease progression.

About Immune Checkpoint Inhibitor-Associated Colitis
Immune checkpoint inhibitors (ICIs) are monoclonal antibodies that target down-regulators of the anti-cancer immune response and have revolutionized the treatment of a variety of malignancies. The global market for ICIs was over $22 billion in 2019 and growing rapidly.¹ However, many immune-related adverse events, especially diarrhea and colitis, limit their use. The incidence of immune-mediated colitis (IMC) with diarrhea ranges from 1% to 30% depending on the type of ICI and whether they are used in combination.² The onset of diarrhea in ICI-AC patients occurs within 6-7 weeks after starting treatment and progressively worsens, and the progression to colitis is rapid and unpredictable. For example, in patients taking ipilimumab (Yervoy), between 25% and 30% of patients developed diarrhea and roughly 8% to 12% developed colitis proven by endoscopy.³ Moreover, the trend is towards the use of combination ICI therapies (e.g., Yervoy and Opdivo) and this will lead to a concomitant increase in both diarrhea and colitis. Administration of corticosteroids, or treatment with certain immunosuppressive biologics, while withholding ICI therapy are recommended for Grade 2 or more severe colitis (National Cancer Institute 2020). The impact of this colitis complication and treatment may reduce the goal of progression free cancer survival. An oral, non-absorbed treatment, such as niclosamide, for Grade 1 or 2 colitis with diarrhea may prevent progression to even more severe Grades of colitis. There currently is no approved treatment for Grade 1 colitis.

About FW-ICI-AC
FW-ICI-AC is a niclosamide-based small molecule anti-inflammatory inhibitor therapy for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and diarrhea in advanced cancer patients. FW-ICI-AC will be supplied to the PASSPORT clinical trial as a proprietary oral immediate-release tablet formulation. The standard care for treating inflammatory bowel diseases (IBD), such as ulcerative colitis and Crohn’s disease, are corticosteroids and other immunosuppressive agents, which can cause problems when used for checkpoint inhibitor patients due to their immunosuppressant effects. FW-ICI-AC has the potential to safely treat Grade 1 and Grade 2 ICI-associated colitis and diarrhea and prevent its progression to more serious and potentially fatal later stages. The overall goal of early niclosamide treatment is to enable oncology patients to remain on, or spend minimal time off, their ICI treatment programs without interruption. Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications.

About First Wave BioPharma, Inc.
First Wave BioPharma, Inc. is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. First Wave BioPharma is currently advancing a therapeutic development pipeline populated with multiple clinical stage programs built around its two proprietary technologies – niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. First Wave BioPharma’s niclosamide portfolio is led by three clinical programs: FW-COV, for COVID-19 gastrointestinal infections; FW-UP, for ulcerative proctitis (UP) and ulcerative proctosigmoiditis; and FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients. Two additional formulations of niclosamide, FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease) are expected to enter the clinic in 2022 and 2023, respectively. First Wave BioPharma is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.firstwavebio.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition and its announcement on the Company’s business, operating results and financial prospects; the integration of the First Wave Bio, Inc. business with the Company’s own business; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@firstwavebio.com

Media contact:
Tiberend Strategic Advisors, Inc.
David Schemelia/ Ingrid Mezo
609) 468-9325 / (646) 604-5150
dschemelia@tiberend.com /imezo@tiberend.com

References:
¹ Immune Checkpoint Inhibitors Market, ResearchAndMarkets.com, 2020.
² Wang et al. Patients with ICPI-induced diarrhea or colitis have improved survival outcomes. J Immunother Cancer. 2018; 6: 37. Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418
³ Wang DY, Ye F, Zhao S, et al. Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: a systematic review and meta-analysis. Oncoimmunology 2017; 10: e1344805; Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418