Nov 17, 2020, 06:30 ET
NEW YORK, Nov. 17, 2020 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced the formation of a Scientific-Medical Advisory Board (SAB). Inaugural members include Drs. Fred D. Lublin, Bruce E. Sands, Jerrold R. Turner and Paul J. Utz, all internationally recognized experts in their respective fields of inflammatory and autoimmune diseases. The newly created SAB will provide management with external scientific review and high-level advice with regard to the company's preclinical and clinical development activities and product pipeline.
"The establishment of a Scientific-Medical Advisory Board marks an important milestone for Immunic and we are honored to have such highly distinguished experts as our inaugural members," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Together, their extensive knowledge, relationships and insights will be invaluable as we continue to advance our pipeline, and in particular our lead program, IMU-838, for which we recently reported very positive results from our phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis and which currently is in additional phase 2 trials for ulcerative colitis, primary sclerosing cholangitis and COVID-19."
Fred D. Lublin, M.D.
Dr. Lublin is a neuroimmunologist with a special interest in immune functions and abnormalities that affect the nervous system. He currently serves as the Saunders Family Professor of Neurology and the Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai in New York. As one of the world's foremost experts on experimental therapies for multiple sclerosis (MS), Dr. Lublin transformed patient outcomes with pioneering studies of Interferon beta-1b before the drug received approval from the U.S. Food and Drug Administration (FDA) in 1993 to treat the relapsing-remitting form of the disease. Over the years, his work has received funding from the National Institutes of Health (NIH), National Multiple Sclerosis Society (NMSS) and the International Progressive MS Alliance, among other organizations.
Dr. Lublin has served on the Board of MS Hope for a Cure and the National Multiple Sclerosis Society. He also served as past Chairman of the National Multiple Sclerosis Society (USA) advisory committee on clinical trials of new MS drugs and Chairman and National Board Member of the Clinical Advisory Committee of the New York City Chapter of the National MS Society. He has published numerous scientific articles and has served as a consultant to the NIH, as well as to pharmaceutical and biotechnology companies in all phases of drug development, including in preparation for drug presentation to the FDA and its advisory panels.
Dr. Lublin earned his medical degree from Jefferson Medical College in Philadelphia, PA and completed an externship at the National Hospital for Nervous Diseases in Queen Square, London. He concluded his formal training in New York with an internal medicine internship at Bronx Municipal Hospital, Albert Einstein Medical Center, and a neurology residency at New York Hospital, Cornell Medical Center. In 2018, Dr. Lublin received the Clifford H. Goldsmith Award for Outstanding Service and the June Halper Lifetime Achievement Award from the Consortium of MS Centers in recognition of his long-standing history of innovative research and commitment to excellence in caring for patients with MS.
Bruce E. Sands, M.D., M.S.
Dr. Sands is the Dr. Burrill B. Crohn Professor of Medicine and Chief, Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai in New York. Prior to joining Mount Sinai, Dr. Sands was Medical Co-Director of the Crohn's & Colitis Center at Massachusetts General Hospital in Boston, where he also served as the hospital's Acting Chief of the Gastrointestinal Unit as well as Associate Professor of Medicine at Harvard Medical School.
A longtime advocate for continued translational research in Crohn's disease and ulcerative colitis, Dr. Sands is widely recognized for his innovative treatment of IBD and for his clinical investigations of new therapeutics. He was among the first to report the efficacy of infliximab, a drug used to treat autoimmune diseases in ulcerative colitis, a result later confirmed in large, multi-center randomized controlled trials.
Dr. Sands has served as the Chair of the Clinical Research Alliance of the Crohn's Foundation of America, Chair of the Immunology, Microbiology and Inflammatory Bowel Disease Section of the American Gastroenterological Association (AGA) and Chair of the International Organization for the Study of IBD. He is an AGA fellow (AGAF) and a fellow of the American College of Gastroenterology (FACG). His work has appeared in several leading peer-reviewed journals, including the New England Journal of Medicine, for which he is also a reviewer, Gastroenterology and Gut. He served as an Associate Editor for the leading journal, Gastroenterology, from 2011 to 2016.
Dr. Sands received his medical degree at Boston University School of Medicine, MA and completed a residency in internal medicine at the Hospital of the University of Pennsylvania in Philadelphia. He completed his clinical and research fellowships at the Massachusetts General Hospital. Dr. Sands also holds a Master of Science in epidemiology from Harvard School of Public Health.
Jerrold R. Turner, M.D., Ph.D.
Dr. Turner is a Professor of Pathology and Medicine at Harvard Medical School. Dr. Turner also serves as a Senior Pathologist in the Department of Pathology at Brigham and Women's Hospital and directs the Laboratory of Mucosal Barrier Pathobiology. Work in the laboratory focuses on tight junction biology and intestinal diseases. These studies have been continuously funded by the National Institutes of Health for over 25 years.
Dr. Turner previously served as the Sara and Harold Lincoln Thompson Professor at the University of Chicago, and as Associate Chair and the Associate Residency Director in the department of Pathology at the University of Chicago. Earlier in his career, he was Assistant/Associate Professor of Pathology at Wayne State University School of Medicine.
Dr. Turner has been published in numerous scientific journals throughout his career. He is the Founding Editor-In-Chief of Cellular and Molecular Gastroenterology and Hepatology, the basic and translational science journal of the American Gastroenterological Association, and has served as the Associate Editor of Gastroenterology, the American Journal of Pathology, and Laboratory Investigation.
Dr. Turner earned his medical degree and Ph.D. from Case Western Reserve University and completed his residency in anatomic pathology at Brigham and Women's Hospital, where he also completed clinical and research fellowships in gastrointestinal and hepatobiliary pathology. He is board certified in anatomic pathology.
Paul J. Utz, M.D.
Dr. Utz is an expert in the study of human and murine autoantibodies and autoantigens, apoptosis signaling pathways, animal models of autoimmunity, proteomics and multiplexed assay development for biomarker discovery. He is currently Professor of Medicine – Immunology & Rheumatology at the Stanford University School of Medicine, where he directs a lab focused on the normal immune system and how it differs with the immune system of patients with immunodeficiency disorders, infections, and autoimmune diseases. Among the autoimmune diseases being studied are systemic lupus erythematosus, rheumatoid arthritis, MS and IBD. In addition to trying to better understand the pathogenic mechanisms involved in autoimmune and inflammatory diseases, the lab is interested in developing bench-to-bedside technologies, including diagnostics and therapeutics, for human immune diseases.
In addition to his research, Dr. Utz has been an innovator in medical student education. He is the Stanford Associate Dean for Medical Student Research, focused on promoting physician investigator development across the physician-scientist career continuum, and is founder of the Stanford Institutes of Medical Research (SIMR), one of the country's largest and most respected immersive high school research programs. He also serves as the Emeritus Director of the Medical Scientist Training Program (MSTP) at Stanford.
Dr. Utz has won numerous faculty teaching awards for his work in the Department of Medicine and Immunology Interdepartmental Ph.D. Program at Stanford, and elsewhere. He is a member of the Scientific Advisory Boards of several biotechnology and pharmaceutical companies, and has co-founded three Bay Area companies.
Dr. Utz earned his medical degree from the Stanford University School of Medicine. He completed his internal medicine residency, rheumatology fellowship, and post-doctoral training at Brigham and Women's Hospital in Boston prior to joining the Harvard Medical School Faculty.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis. Immunic is developing three small molecule products: its lead development program, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect; IMU-935 is an inverse agonist of RORγt; and IMU-856 targets the restoration of the intestinal barrier function. Immunic announced positive results from its phase 2 EMPhASIS trial of IMU-838 in patients with relapsing-remitting multiple sclerosis, reporting achievement of both primary and key secondary endpoints with high statistical significance. IMU-838 is also in phase 2 clinical development for ulcerative colitis and COVID-19, with an additional phase 2 trial considered in Crohn's disease. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. For further information, please visit: www.imux.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's three development programs and the targeted diseases; the potential for IMU-838, IMU-935 and IMU-856 to safely and effectively target diseases; the nature, strategy and focus of the company; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; and the structure, composition and potential contributions of the company's scientific-medical advisory board. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on March 16, 2020, the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 6, 2020, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.
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