MADISON, Wis.--(BUSINESS WIRE)--FluGen, Inc. announced today that the company's novel M2 deleted, single replication (M2SR) influenza vaccine was safe and well tolerated, generated a dose-response effect for both humoral and mucosal antibodies, and produced robust T-cell responses in a first-in-human phase 1a trial of 96 healthy volunteers ages 18-49 years. The data are being presented at the annual ID Week conference (abstract #71884, Saturday, October 6) in San Francisco.
"The strong safety and immunogenicity data we see in this study are consistent with a vaccine that could provide broad and durable protection against influenza," said Robert Belshe, M.D., one of the study's lead authors, and the Diana and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology, Emeritus, at Saint Louis University.
The FluGen vaccine utilizes a proprietary M2SR influenza virus. The M2 gene is essential for the influenza virus to spread in the patient and the deletion of the M2 gene restricts the virus to a single replication cycle in the host. The body recognizes M2SR as an influenza infection and activates its robust immune response, but, because the virus can only replicate once, it cannot spread to other cells and cause symptoms of a real-world infection.
"This Phase 1a study highlighted the safety and immunogenicity profile of FluGen's M2SR influenza vaccine. We look forward to completing our ongoing challenge study and using that data to further guide our next steps, as we seek to increase the effectiveness of influenza vaccination," said Paul Radspinner, president and CEO of FluGen.
Based on these data, in May 2018, FluGen initiated an ongoing challenge trial with an influenza strain that is intentionally mis-matched by six years from the vaccine strain. Results from this ongoing challenge study are expected in the first half of 2019. The ongoing challenge study is supported by a $14.4 million grant from the Department of Defense. The U.S. Army Medical Research Acquisition Activity is the awarding and administering acquisition office and this work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program under Award No. W81XWH-17-1-0430.
Study volunteers (N=96) ages 18-49 years received a single intranasal inoculation with either M2SR at dose levels of 106, 107 or 108 TCID50 or saline placebo (N=24/cohort). Study subjects were evaluated for virus replication and local and systemic immune reactions for seven days. They were monitored for any adverse events for 28 days and any serious adverse events for 180 days.
No infectious virus was detected in nasal swabs from any vaccinated subject. The most commonly reported adverse event was mild nasal rhinorrhea/congestion during the first seven days after vaccination. No subject had fever or a severe reaction to the vaccine. No serious adverse events were reported. At least one adverse event was reported among 29%, 58%, and 83% of M2SR subjects administered 106, 107, or 108 TCID50, respectively, and 46% among placebo subjects. There were no notable imbalances among study groups for other events.
T-cell and B-cell responses, including influenza-specific serum and mucosal antibody responses were detected at a significantly higher frequency among vaccine than placebo subjects.
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. Yoshihiro Kawaoka at the University of Wisconsin, Madison. FluGen's lead product candidate, an M2SR vaccine, is a universal flu vaccine which is based on the knowledge that a natural or wild-type flu infection prevents people from being infected in subsequent years. The M2SR vaccine has demonstrated a robust immunology profile that works through multiple immune pathways systems and appears to convince the body it has been infected, triggering a robust immune response while not displaying flu symptoms.