M04NM11

M04NM11 is an investigational oral therapeutic vaccine candidate developed by Emergent BioSolutions (through its subsidiary Emergent Product Development UK, formerly Microscience) for the treatment of chronic hepatitis B virus (HBV) infection. The vaccine is based on the spi-VEC platform, which utilizes a live-attenuated strain of *Salmonella enterica* serovar Typhi (Ty21a) as a delivery vector. M04NM11 is engineered to express the hepatitis B core antigen (HBcAg). Upon oral administration, the attenuated bacteria are intended to target the gut-associated lymphoid tissue (GALT), where they deliver the antigen to professional antigen-presenting cells. This approach is designed to stimulate a potent, HBV-specific cellular immune response (CD4+ and CD8+ T cells) to overcome the immune tolerance characteristic of chronic HBV infection. A Phase 1 dose-escalation study was conducted to evaluate its safety and immunogenicity in patients with chronic HBV, but the program is no longer listed in the company's active pipeline.

Other names

oral HBV therapeutic vaccine