The Flu Has a Formidable Foe in M2SR
The M2 Deleted Single Replication Live Virus Vaccine (M2SR) offers a potentially differentiating clinical value proposition. FluGen’s flu vaccine candidate works differently, stimulating mucosal, humoral, and cellular immunity, and offering unprecedented efficacy against infection and illness across seven years of virus drift, and documented steady immune response for at least six months.
M2SR contains influenza vaccine viruses (both A and B strains) with a deletion in a portion of the M2 gene. The M2 protein is added back during manufacturing, resulting in a single round of viral replication. M2SR viruses can infect cells, express the entire spectrum of influenza RNA and proteins, but cannot produce infectious virus particles. As such, M2SR vaccines do not shed infectious virus, and do not cause pathological signs of infection. This leads to a favorable safety profile in FluGen’s clinical studies where it has been well-tolerated with no serious adverse effects.
The M2SR viruses can be engineered to express the HA and neuraminidase antigens (NA) of any influenza virus, and can be manufactured in cell lines that stably express the M2 protein.
M2SR Addresses Current Vaccine Limitations
FluGen’s M2SR Vaccine Platform stimulates all adaptive immune responses, unlike leading flu vaccines. It offers broader drift protection, with proven efficacy against matched and drifted strains. It has a documented and durable immune response of at least six months and can be administered to pediatric patients through the elderly. M2SR is currently being studied in subjects ranging from 6 months to over 80 years.