FluGen, Inc. announced that the first subject has been dosed in a clinical study in Belgium which will challenge subjects with an influenza virus genetically mismatched by six years from the influenza strain utilized in the vaccine.
FluGen’s M2SR vaccine seeks to address this challenge. The vaccine utilizes a proprietary M2 deleted, single replication (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.
Patients naturally infected with wild type influenza often are protected from future influenza illness for many years. By tricking the body into believing it has been infected with influenza, the M2SR vaccine is designed to activate this broad and durable wild type immune response, without causing influenza disease.
The study is supported by a $14.4 million grant from the U.S. Department of Defense and will be helb conducted by SGS in Belgium. A prior Phase 1a study of FluGen’s M2SR vaccine in 96 subjects showed the vaccine to be generally safe and well tolerated, and to generate a robust immune response.
FluGen, a biopharmaceutical company specializing on the prevention and treatment of seasonal and pandemic influenza worldwide, was founded in 2007 in Madison, Wisconsin (USA) in response to the need for better methods of preventing influenza infections.