U.S. DOD Grants $11.4 Million to Study Supra-Seasonal Flu Vaccine Candidate

Wisconsin-based FluGen, Inc. announced that it had been awarded funding from the United States Department of Defense (DOD) to conduct a safety and immunogenicity study of M2SR, the Company's investigational, supra-seasonal, live, single-replication, intranasal influenza vaccine.

This study will evaluate a monovalent H3N2 flu vaccine candidate compared to a licensed quadrivalent vaccine that is considered the current standard of care for adults aged 65 and above.

The study is designed to measure a breadth of immune responses against both vaccine-matched and drifted influenza strains amongst study subjects who receive either vaccine alone, both vaccines administered simultaneously, or both given sequentially. And the study will also assess seroconversion and seroprotection to identify the number of subjects who respond with antibodies to drifted strains of the flu virus.

Paul Radspinner, President and CEO, FluGen, Inc., said in a press statement issued on July 1, 2021, "FluGen is committed to ensuring older adults are protected from the flu virus, and particularly drifted strains, and the current standard of care has not been shown to be widely effective in protecting this population from virus drift, particularly against H3N2."

"We believe M2SR has the potential to be a more effective vaccine option in older adults, as it induces a broad antibody response, including mucosal, humoral, and cellular immunity, even in the presence of pre-existing immunity to the flu. This represents a critical advancement in flu protection, and we look forward to initiating our study in the second quarter of 2022."

The M2SR vaccine candidate contains vaccine viruses with a deletion in a portion of the M2 gene. M2SR viruses can infect cells, express the entire spectrum of influenza RNA and proteins, yet cannot produce any infectious virus particles. Thus, the M2SR vaccines do not shed infectious viruses and do not cause any pathological signs of infection. 

The study is supported by an $11.4 million grant from the DOD. 

FluGen, Inc. is a clinical-stage vaccine company located in Madison, Wis., transforming vaccine efficacy in respiratory diseases.