SOUTH SAN FRANCISCO, Calif., Aug. 19, 2021 /PRNewswire/ -- Vaxart, Inc. (NASDAQ: VXRT), today announced the creation of an eight-member Scientific and Clinical Advisory Board.
The Advisory Board, whose first meeting occurred on July 24, 2021, is comprised of medical and health care professionals who are vaccine, research, and academic experts in immunology, microbiology, and infectious diseases.
"We are excited to have such preeminent leaders in their fields joining our Scientific and Clinical Advisory Board," said Andrei Floroiu, Vaxart's Chief Executive Officer. "We believe their participation reflects the seriousness of our mission, our science, and the disruptive promise of our oral vaccines. We will benefit from access to their years of experience and deep expertise as we continue to advance our portfolio of programs."
"I am excited by the work Vaxart is doing and the promise its work holds for improving public health," said Advisory Board member Dr. Robert B. Belshe, Adorjan Endowed Professor Emeritus of Infectious Diseases and Immunology at Saint Louis University.
"A room-temperature stable pill has the promise to change how we vaccinate people both in the U.S. and abroad. An oral tablet vaccine could help vaccinate more people sooner in more corners of the world, and thus has the potential to make a major contribution to public health globally," Dr. Belshe added.
The eight leaders joining Vaxart's Scientific and Clinical Advisory Board are:
Ralph Baric, Ph.D.
Professor, Department of Epidemiology, Microbiology,
Gillings School of Global Public Health
University of North Carolina
Ralph Baric, Ph.D., is a Distinguished Professor in the Department of Epidemiology and a Professor in the Department of Microbiology and Immunology. In addition, he is a World Technology Award Finalist and a fellow of the American Association for Microbiology. He has spent the past three decades as a world leader in the study of coronaviruses and is responsible for UNC-Chapel Hill's world leadership in coronavirus research.
The Baric Lab uses coronaviruses as models to study the genetics of RNA virus transcription, replication, persistence, pathogenesis, genetics, and cross-species transmission. He has used alphavirus vaccine vectors to develop novel candidate vaccines.
In 2017, 2018, and 2019, Baric was named to Clarivate Analytics' Highly Cited Researchers list, which recognizes researchers who have published the most widely cited papers in their field. In 2017, he was awarded a grant from The National Institute of Allergy and Infectious Diseases (NIAID) to accelerate the development of a new drug in the fight against coronaviruses, which is currently in clinical trials to reverse COVID-19 disease in humans. In this collaboration, he continued his partnership between the Gillings School of Global Public Health and Gilead Sciences to focus on an experimental antiviral treatment that he had previously shown to prevent the development of severe acute respiratory syndrome coronavirus (SARS-CoV) in mice. The drug was also shown to inhibit MERS-CoV and multiple other coronaviruses (CoV), suggesting that it may actually inhibit all CoV. He continues to work with this drug.
Robert Belshe, M.D.
Professor Emeritus, Division of Infectious Diseases, Allergy, and Immunology,
Founder, Center for Vaccine Development
St. Louis University
Robert Belshe, M.D., directed the NIH-funded Vaccine and Treatment Evaluation Unit (VTEU) at St. Louis University for the past three decades. His clinical and laboratory research interests include the development of live attenuated respiratory virus vaccines. Recent clinical projects include the evaluation of novel vaccines for influenza, including the live attenuated influenza vaccine available for children and adults aged 2-49. Belshe coordinated 50 other academic centers to evaluate a subunit vaccine for HSV2 in women ages 18-30. More than 8,300 women participated in the trial.
Past successes include evaluating haemophilus conjugate vaccines in infants and pneumococcal vaccines in infants and adults, demonstrating that smallpox vaccine dilutions could extend the national vaccine reserve by tenfold, evaluating the efficacy of acellular pertussis vaccines in college students, and developing a live attenuated vaccine as an improved vaccine for influenza.
Collaborations between the Vaccine Center and the Saint Louis University Liver Center led to the first-in-human studies of a prophylactic vaccine for hepatitis C. The Division of Infectious Diseases and VTEU have significant collaborations beyond the University, including the Midwest Research Center for Excellence for Biodefense Studies.
Stefan Gravenstein, M.D.
Professor of Medicine,
Director, Division of Geriatrics and Palliative Care
Stefan Gravenstein, M.D., is a professor in the departments of Medicine and Health Services Policy and Practice at Brown University's schools of medicine and public health and serves as the Director of the Division of Geriatrics and Palliative Medicine at the Alpert Medical School of Brown University.
Dr. Gravenstein has a long-standing interest in immunity, aging and vaccines, especially in the context of long-term care settings, topics represented in the majority of his publications.
Gregory Gray, M.D.
Professor of Medicine, Division of Infectious Diseases
Duke University School of Medicine
Gregory C. Gray, M.D., MPH, FIDSA is an infectious disease epidemiologist and Professor at Duke University with three affiliations: The Division of Infectious Diseases in Duke University's School of Medicine, the Duke Global Health Institute, and the Duke Nicholas School of the Environment. He also serves as a Professor in the Program in Emerging Infectious Diseases and the Global Health Institute at Duke-NUS Medical School, Singapore, and as a Professor of Global Health at Duke Kunshan University in China.
He leads the Duke One Health Network, which involves more than 30 professionals studying more than 30 pathogens under 30 research and training projects running in multiple countries: China, Iraq, Malaysia, Mongolia, Myanmar, Pakistan, Singapore, South Africa, the Philippines, the United States, and Vietnam.
Dr. Gray has conducted diverse epidemiological studies of infectious diseases for 25 years in five continents. He has authored more than 300 peer-reviewed manuscripts and book chapters.
Much of his work has involved identifying risk factors for occupational diseases, particularly for respiratory virus infections. A strong supporter of the One Health approach, he has won multiple One Health research and training grants, helped establish centers of One Health (in the U.S., Romania, and China), and developed four graduate programs in One Health (PhD, MHS, and certificate).
He has served on various expert scientific committees and boards and has won numerous professional awards. In 2019, he was elected to serve as a member of the prestigious U.S. think tank, the Council on Foreign Relations.
Harry Greenberg, M.D.
Joseph D. Grant Professor in the School of Medicine,
Associate Dean for Research
Harry B. Greenberg, M.D., the Joseph D. Grant Professor in the School of Medicine and Associate Dean for Research at Stanford University was the lead inventor of the first-generation vaccine for rotavirus, a severe diarrheal disease that kills between 300,000 and 400,000 children each year in the developing world.
Dr. Greenberg's current interests are in pathogenic viruses that infect the GI tract, liver, and respiratory tract. His primary focus is on molecular mechanisms of pathogenesis, viral determinants of protective immunity, the molecular basis of host range, virulence and tissue tropism, vaccine development, viral immunology, and epidemiology, with specific emphasis on the role of enteric viruses in less developed countries.
Marion Pepper, Ph.D.
Associate Professor, Immunology
University of Washington
Marion Pepper graduated with a bachelor's degree in Biology and English from Williams College and received her Ph.D. in Immunology in 2006 from the University of Pennsylvania. She completed postdoctoral training at the University of Minnesota and joined the Department of Immunology as an Assistant Professor in 2011, and was promoted to Associate Professor 2017.
She will be the Interim Chair of the University of Washington (Washington) Department of Immunology, effective September 2021.
The Pepper Lab at Washington is investigating the immune memory response to SARS-CoV-2 in adults who have recovered from mild COVID-19. This immune memory may help the body fight off the virus in the future. It is also investigating how previously SARS-CoV2 infected adults respond to COVID-19 vaccines compared to adults who were not previously infected.
Stanley A. Plotkin, M.D.
Emeritus Professor, University of Pennsylvania
Adjunct Professor, Johns Hopkins University
Principal, Vaxconsult, LLC
Stanley A. Plotkin, M.D., is an Emeritus Professor at the University of Pennsylvania and an Adjunct Professor at Johns Hopkins University. Until 1991, he was Professor of Pediatrics and Microbiology at the University of Pennsylvania, Professor of Virology at the Wistar Institute, and at the same time, Director of Infectious Diseases and Senior Physician at the Children's Hospital of Philadelphia. In 1991, Plotkin left the University to join the vaccine manufacturer, Pasteur-Mérieux-Connaught, where for seven years he was the Medical and Scientific Director, based at Marnes-la-Coquette, now known as Sanofi Pasteur.
Dr. Plotkin has developed several pediatric vaccines, including the rubella vaccine now in standard use throughout the world and a recently licensed pentavalent rotavirus vaccine. He has also been involved in other vaccine development programs, including anthrax, oral polio, rabies, varicella, and cytomegalovirus.
Dr. Plotkin's bibliography includes nearly 800 articles, and he has edited several books, including the standard textbook on vaccines, now in its 7th edition. He is a consultant to vaccine manufacturers, biotechnology companies, and non-profit research organizations as principal of Vaxconsult, LLC.
Dr. Plotkin attended New York University, where he received a B.A. degree, and then the State University of New York Medical School in Brooklyn, where he received an M.D. degree in 1956.
George Siber, M.D.
Member, Board of Directors, Affinivax
Adjunct Professor, Johns Hopkins School of Medicine
George R. Siber, M.D., is an internationally recognized vaccine expert with 40 years of experience in developing numerous innovative vaccines. From 1975 to 1996, Dr. Siber served on the Faculty of Medicine at Harvard University as Assistant and Associate Professor of Medicine based at the Dana Farber Cancer Institute. Concurrently, from 1982 to 1996, Dr. Siber was Director of the Massachusetts Biologic Laboratories. Under his leadership, the laboratory developed specific immune globulins to CMV (Cytogam) and to RSV (Respigam) the precursor product to Synagis.
From 1996 to 2007, Dr. Siber was Executive Vice President and Chief Scientific Officer of Wyeth Vaccines Research, overseeing the development, approval, and marketing of six innovative childhood vaccines including Prevenar, the first pneumococcal conjugate vaccine, Meningitec, the first Meningococcal C conjugate vaccine, Rotashield, the first rotavirus vaccine and FluMist, the first live nasal influenza vaccine.
Dr. Siber currently serves on the Board of Directors of Genocea and on the Scientific Advisory Boards of CureVac, ILiAD, Valneva, Vaxess, AdVaccine, CanSino, Vaxxinity and Clover. Dr. Siber has received multiple awards including the 2016 Albert Sabin Gold Medal in vaccinology.
Vaxart is a clinical-stage biotechnology company developing a range of oral vaccines based on its proprietary delivery platform called VAAST™. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design vaccines for new indications. Vaxart's development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to the Advisory Board's impact on Vaxart's business and future outlook; Vaxart's expectations regarding clinical results and trial data; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart 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. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.
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