September 19th, 2017
MADISON, WI — Today FluGen Inc., a clinical stage vaccine company, announced that Dr. Robert Belshe was named Chairman of the Company’s Clinical Advisory Board (CAB). Along with Dr. Belshe’s appointment, FluGen is expanding the roles of all members of the CAB to guide the Company through the clinical development of RedeeFlu™. The Company is focused on the development of a novel intranasal flu vaccine (M2SR, or RedeeFlu) that mimics natural infection without causing illness, thereby providing the hope of a broader and more durable protection than is currently available. The FluGen CAB is made up of Drs. Belshe, Kathleen Coelingh, Harry Greenberg and John Treanor, along with Company founders Drs. Yoshihiro Kawaoka and Gabriel Neumann.
FluGen’s Executive Chairman, C. Boyd Clarke, commented that “We are pleased that our approach to flu immunization has attracted such an outstanding group, with deep expertise in the development of novel approaches to influenza immunization.” Dr. Belshe is the Diana and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology, Emeritus, at Saint Louis University and is a recognized expert in clinical trials design and execution. His laboratory focuses on antibody responses to viral vaccines, including influenza, RSV and herpes. He chaired the NIH/industry cooperative Phase 3 pivotal licensing studies on live attenuated influenza vaccine (FluMist), and most recently chaired the NIH and Glaxo-Smith-Kline (GSK) Herpevac Trial for Women.
The expanded role for the CAB was prompted by the Company’s clinical plans. FluGen anticipates conducting multiple Phase 1 & 2 clinical studies in coming years to move RedeeFlu™ toward approval. “There is no question that influenza is a killer- particularly in very young children and older adults. Current vaccines work to some degree but we can do better” said Dr. Belshe. “I am pleased to work with the team to shape this potentially important program”.
FluGen’s technology is based on the fact that once the body has experienced a real or “wild-type” flu infection, it is unlikely to be infected again for a number of years. The Company’s vaccine candidate, RedeeFlu™, mimics an authentic flu infection without the headache, fever and other symptoms caused by the disease. Co-founder Dr. Kawaoka commented that “We know that those who suffer influenza infections seldom experience another infection in the following years. By creating a flu virus that will trick the body into believing it has been invaded but with no sickness, we hope that we have found a way to protect people not only in years when the vaccine does not match the infection but we hope to see multi-year protection as well. Time will tell.”
About the FluGen Clinical Advisory Board Members:
Kathleen L. Coelingh, Ph.D. was Senior Director, Medical Affairs at MedImmune, the biologics unit of AstraZeneca. Prior to that while at the NIH she led the team that discovered the mouse monoclonal antibody that neutralizes Respiratory Syncytial Virus (RSV), which was humanized at MedImmune and is licensed for prevention of serious lower respiratory tract disease caused by RSV in high-risk pediatric patients.
Harry B. Greenberg, M.D. is currently the Associate Dean for Research at Stanford University School of Medicine and the Director of Spectrum, the Stanford/NIH funded clinical and translational research center. He is also the Joseph D. Grant Professor of Medicine and Microbiology and Immunology at Stanford Medical School. He has authored more than 450 primary research and review articles and over the years has worked on a variety of pathogenic human viruses including influenza, hepatitis B and C, norovirus and rotavirus. He is a past president of the American Society of Virology, has served as the chair of the FDA Advisory Committee on Vaccines and Related Biologics, and as the Chair of the Medical Sciences Section of the AAAS. He was the Chief Scientific Officer at Medimmune Vaccines during a 2-year leave of absence from Stanford.
John Treanor, M.D. is an infectious disease specialist in Rochester, New York. He received his medical degree from University of Rochester School of Medicine and Dentistry and has been in practice for more than 20 years. He is the Director of the New York Influenza Center of Excellence and is a former voting member of the Advisory Committee on Immunization Practices (ACIP). Dr. Treanor serves on editorial boards and is a reviewer for multiple publications in the field of infectious diseases. He has been involved in several clinical studies for virtually all marketed and some novel influenza vaccines.
Co-founder Yoshihiro Kawaoka, Ph.D. has been studying influenza viruses for more than 30 years. His work has helped to answer key questions in influenza virus research such as how influenza viruses cause disease, why certain types of influenza viruses are found in humans while other types are found only in birds and how influenza viruses change over time. In 2006, Dr. Kawaoka was awarded the prestigious Robert Koch Award for his innovative research in the field of influenza virology. He currently maintains joint appointments and highly active influenza research programs at both the University of Wisconsin-Madison and the University of Tokyo.
Co-founder Gabriel Neumann, Ph.D. brings both significant academic and industry experiences to FluGen Inc. She is a trained molecular virologist with more than 15 years working with the influenza virus. Her graduate studies in Germany were instrumental in the breakthrough of “reverse genetics” during her postdoctoral fellowship in Dr. Kawaoka’s research group. For this accomplishment Dr. Neumann was awarded the Loeffler-Frosch Award in 2000. She also spent time in industry with Wyeth (now Pfizer) where she worked on the development of FluMistTM/ CAIV-T. In 2002, she rejoined Dr. Kawaoka’s research group, where she currently holds the position of Research Associate Professor.
FluGen, Inc. is a clinical stage vaccine company focused on improving the breadth and effectiveness of influenza vaccines. The Company’s technology comes from the laboratory of Dr. Yoshi Kawaoka at the University of Wisconsin, Madison. It’s lead product candidate, RedeeFlu™ is a universal flu vaccine which is based on the knowledge that a real or “wild-type” flu infection prevents people from being infected in subsequent years. RedeeFlu™ has demonstrated a robust immunology profile that works on multiple effector systems and appears to trick the body into believing it has been infected without flu symptoms. RedeeFlu™ will enter Phase 2 clinical trials in 2018.
For more information about RedeeFlu please visit